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Abstract of dissertation entitled
“An evidenced-based guideline on yoga in reducing cancer
related fatigue among female breast cancer patients”
Submitted by
NG Ka-chun
For the degree of Master of Nursing
At The University of Hong Kong
In August 2016
Abstract
Breast cancer is a malignant tumor that originates in the cells of the breast
which occurs mainly in women (99%) (National Breast Cancer Foundation, 2015).
Cancer related fatigue is a common, persistent, and subjective sense of tiredness
related to cancer or to treatment for cancer that interferes with usual function (Mock
et al., 2000). About 40%-100% of female breast cancer patients experience fatigue
(Stasi, 2003). They will commonly rest or consult physicians for medication, however,
they are not the effective solution. Evidences support that yoga practice can
decrease cancer related fatigue effectively.
In Hong Kong, protocol or service for yoga practice program targeting female
breast cancer patients is limited even though the effectiveness is evidence-based
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supported. In this present study, PubMed (1950 - 2015) and CINAHL PLUS (1982 -
2015) were adopted as the database for related evidence searching engines. Five
randomized controlled studies were obtained for in depth studies. The five selected
literatures were all high quality studies with supportive result to identify the
improvement on cancer related fatigue for female breast cancer patients.
This present study proposed a yoga practice program for a families clinic in
Department of Health in Hong Kong. The target population is adult (age 18 or above)
female patients with stage 0 to III breast cancer and cancer related fatigue. In
addition, they should have no current yoga practice and the last time of yoga practice
was more than 3 months before. The enrolled patients will have yoga practice for
twice a week with 60 minutes for each session. The whole yoga program will last for
6 weeks. Well trained nurses will be the tutors and supervisors for progress
monitoring and safety assurance in each session. Evidence based protocol is
developed for the innovation to guide the nurses to carry out the yoga practice
program effectively and safely. The Scottish Intercollegiate Guidelines Network (SIGN)
grading system is adopted as the measuring tool for the level of evidence and grading
of the recommendations in the protocol.
Communication plan is established to gain support from the identified
stakeholders. Pilot study will be conducted for feasibility test and program
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enhancement before implementation. Cancer related fatigue as measured by Brief
Fatigue Inventory in Taiwan version (BFI-T) is the primary outcome of the innovation.
Besides, knowledge and satisfaction level of staff will be evaluated.
The core effectiveness of innovation will be evaluated by the primary outcome
of the study: cancer related fatigue level, which can in turn be assessed by Fatigue
Inventory in Taiwan version (BFI-T). Besides, staff satisfaction and knowledge level
are 2 keys factors of effectiveness assessment.
The transferable elements of the innovation include characteristics of targeted
population, staff, clinical setting and philosophy of care. The feasibility of the
innovation is assessed according to culture, resources and setting. The cost
effectiveness is evaluated which supports the application of the innovation. For
efficient implementation of this program, a well-designed evidence-based protocol is
developed. The innovation is designed to improve cancer related fatigue of female
breast cancer patients effectively.
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An evidenced-based guideline on yoga in reducing cancer
related fatigue among female breast cancer patients
By
NG Ka-chun
Bachelor of Nursing (Hons) H.K.U.
A thesis submitted in partial fulfillment of the requirements for
The degree of Master of Nursing
At The University of Hong Kong
August 2016
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Declaration
I declare that this thesis represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a
thesis, dissertation or report submitted to this University or to any other
institution for a degree, diploma or other qualification.
Signed: _____________________
Ng Ka-chun
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Acknowledgements
I would like to express my deepest gratitude to my dissertation supervisor, Dr.
HONG Wai-lin, Athena, for her valuable advices, guidance, support and
encouragement in my dissertation journey. Besides, I would like to show my sincere
thanks to the staff in the School of Nursing, The University of Hong Kong. They made
great effort in providing quality educational activities to enrich and consolidate my
skills of research which lead to the successful completion of my dissertation.
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Contents
Abstract………………………………………………………………………………………………………………..…01
Front Page………………………………………………………………………………………………….…………..04
Declaration…………………………………………………………………………………………………….……….05
Acknowledgements…………………………………………………………………………………………….…..06
Contents………………………………………………………………………………………………………………….07
Chapter 1: Introduction……………………………………………………………………………………….12
1.1 Background……………………………………………………………………………………………….12
1.2 Affirming the Needs…………………………………………………………………………………..13
1.2.1 Local Service Need……………………………………………………………………….13
1.2.2 Clinical Issues in Target Setting…………………………………………………....14
1.2.3 Innovation Introduction……………………………………………………………....15
1.2.4 Need of Systematic Reviews…………………………………………………………16
1.3 Objectives and Significance……………………………………………………………………….16
1.3.1 Objectives…………………………………………………………………………………….16
1.3.2 Significance………………………………………………………………………………....17
Chapter 2: Critical Appraisal…………………………………………………………………………………18
2.1 Search and Appraisal Strategies…………………………………………………………………18
2.1.1 Inclusion and Exclusion Criteria……………………………………………………18
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2.1.2 Search Strategy…………………………………………………………………………….19
2.1.3 Appraisal Strategy………………………………………………………………………..19
2.2 Results……………………………………………………………….……………………………………..20
2.2.1 Search Results………………………………………………………………………………20
2.2.2 PRISMA Flowchart……………………………………………………………………….20
2.2.3 Table of Evidence Description………………………………………………………20
2.2.4 Summary of Appraisal Results………………………………………………………21
2.3 Summary and Synthesis…………………………………………………………………………….22
2.3.1 Summary of Conclusions of Selected Studies……………………………….22
2.3.2 Study results synthesis…………………………………………………………………23
2.3.3 Evidence support conclusion………………………………………………………..32
Chapter 3: Implementation Potential and Clinical Guideline………………………………..34
3.1 Transferability……………………………………………………………………………………………34
3.1.1 Target Setting………………………………………………………………………………….34
3.1.2 Philosophy of Care………………………………………………………………………….35
3.1.3 Target Population……………………………………………………………………………35
3.1.4 Innovation Period……………………………………………………………………………37
3.2 Feasibility…………………………………………………………………………………………………..38
3.2.1 Staff……………………………………………………………………………………………..…38
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3.2.2 Organization…………………………………………………………………………….……..40
3.2.3 Skills, Equipment and Facilities……………………………………………………….41
3.2.4 Measuring Tool……………………………………………………………………………….42
3.3 Cost-Benefit Ratio……………………………………………………………………………………..43
3.3.1 Risk to Clients………………………………………………………………………………….43
3.3.2 Risk of Maintaining Current Practice……………………………………………….43
3.3.3 Potential Benefit……………………………………………………………………………..44
3.3.4 Setup Cost………………………………………………………………………………………44
3.4 Evidence-Based Practice Guideline…………………………………………………………….46
Chapter 4 Implementation Plan…………………………………………………………………………..48
4.1 Communication Plan………………………………………………………………………………….48
4.1.1 Identify Stakeholders………………………………………………………………………48
4.1.2 Communication Pathway……………………………………………………………..…50
4.2 Pilot Study Plan………………………………………………………………………………………….52
4.2.1 Feasibility of Implementation………………………………………………………….52
4.2.2 Subject Enrollment………………………………………………………………………….53
4.2.3 Action Plan…………………………………………………………………………………..…53
4.2.4 Data Collection and Instrument………………………………………………………54
4.2.5 Evaluation of the Pilot Study……………………………………………………………54
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4.2.6 Pilot Study Timeline………………………………………………………………………..54
4.3 Evaluation Plan………………………………………………………………………………………….55
4.3.1 Identification of Evaluation Targets…………………………………………………55
4.3.2 Sample Size Calculation…………………………………………………………………..55
4.3.3 Outcome Evaluation……………………………………………………………………….56
4.3.4 Data Analysis…………………………………………………………………………………..58
4.3.5 Evaluation Timeline…………………………………………………………………………59
4.4 Basis for Implementation…..………………………………………………………………………59
Chapter 5 Conclusion…………………………………………………………………………………………..61
Appendix I PRISMA 2009 Flow Diagram…………………….…………………………………………….63
Appendix II Table of Evidence……………………………………………………………………………......64
Appendix III SIGN appraisal checklists……………………………………………………………………..67
Appendix IV Brief Fatigue Inventory (Taiwan Version)……………………………………………..73
Appendix V Budgeting Table……………………………………………………………………………………75
Appendix VI Table of Study Design………………………………………………………………………….76
Appendix VII Implementation Guideline……………………………………………………………….…78
Appendix VIII Nurses Questionnaire………………………………………………………………………..82
Appendix IX Pilot Study Flow Chart…………………………………………………………………………84
Appendix X Case Recruitment Flowchart………………………………………………………………...85
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Appendix XI Yoga Program Flowchart………………………………………………………………………86
References………………………………………………………………………………………………………………87
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Chapter 1 Introduction
This chapter introduces the background information and explores the need for a
study on the effectiveness of yoga on relieving cancer related fatigue of female
breast cancer patients in Hong Kong. It provides the definition of important terms of
the thesis. Finally, it states the objectives and significance of this study.
1.1 Background
Breast cancer is a malignant tumor that originates in the cells of the breast, which
occurs mainly in women (99%)(National Breast Cancer Foundation, 2015). It can be
divided into non-invasive breast cancer (Ductal Carcinoma in situ and Lobular
Carcinoma in situ) and invasive breast cancer (Early breast cancer, Paget's disease of
the nipple, Inflammatory breast cancer, Locally advanced breast cancer and
Secondary breast cancer) (Breast Cancer Network Australia, 2015). By tumor
pathology, breast cancer can be classified as hormone receptor positive breast cancer,
HER2-positive breast cancer and Triple negative breast cancer (Breast Cancer
Network Australia, 2015). To classify the severity and estimate prognosis, breast
cancer can be further staged as stage 0, IA, IB, IIA, IIB, IIIA, IIIB, IIIC and IIII by T
(primary tumor), N (nearby lymph node), M (metastasis) system (America Cancer
Society, 2015).
Yoga is a popular exercise, especially among women. It originated in India with
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growing popularity in recent decades because of its comprehensive benefits. It is a
mind-body exercise including postures, breathing technique and meditation
providing positive physiological and psychological effects (Carson et al., 2009) (Van
Uden-Kraan et al., 2013).
Cancer related fatigue is a kind of fatigue which is only experienced by the cancer
patients because of the nature of neoplasm and side effects of treatments. About
40%-100% of female breast cancer patients experience fatigue (Stasi et al., 2003). As
defined by National Comprehensive Cancer Network (NCCN), it is a common,
persistent, and subjective sense of tiredness related to cancer or treatments that
interfere with usual functioning (Mock et al., 2000). Unlike tiredness, cancer related
fatigue is more severe and distressing but it cannot be relieved by rest (Glaus, Crow,
Hammond, 1996) (Fukuda et al., 1994).
1.2 Affirming the need
1.2.1 Local service need
With reference to Breast Cancer Registry Report No. 7 in 2014, breast cancer
has become the most common cancer among women in Hong Kong since 1993 (Hong
Kong Cancer Registry, 2014). The new cases increased from 1152 in 1993 to 3508 in
2012, accounting for 25.8% of total female cancer cases (Hong Kong Cancer Registry,
2014). It is showed 9 women will be diagnosed with breast cancer daily (Hong Kong
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Cancer Registry, 2014). The median age of patients is 54, which is lower than most
developed countries (e.g.: USA, Australia) (Hong Kong Cancer Registry, 2014). Except
for surgery (98.3%), chemotherapy (60.5%) and radiotherapy (62.2%) are two most
common adjuvant treatments for breast cancer that will induce or exacerbate cancer
related fatigue of patients (Hong Kong Cancer Registry, 2014).
1.2.2 Clinical issue in target setting
With the medical advancement, the survival rate has been increasing and stayed
at high rate. National Cancer Institute’s SEER database showed that the mean of
5-year survival rate of stage 0-III breast cancer is 91% (National Cancer Institute,
2015). Cancer related fatigue is one of the most prevalent symptoms among breast
cancer patients (Carlson et al., 2004). It is one of the most challenging and distressing
symptoms which exerts a great impact on patient’s quality of life (Minton & Stone,
2008). With the increasing number of female breast cancer patients, apart from the
treatment needs, the need for post-treatment care is also soaring. In family clinics,
there is an increasing trend for breast cancer survivors to seek medical consultation
for cancer related fatigue. To grasp the brief idea on the clinical situation, informal
interviews were conducted to female breast cancer survivors and doctors. Patients
expressed their helplessness and annoying feeling towards cancer related fatigue. It
is because rest cannot help and it makes them become inactive and this does affect
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their daily lives. However, when they seek medical consultation in clinics, doctors will
only offer simple comfort and hypnotics which cannot help to address their need.
From doctor’s point of view, fatigue is a symptom but not an illness or disease which
requires medical consultation and treatment. Offering hypnotics and sick leave are
what they can do. However, patients keep returning for the same reason of
consultation, which makes doctors suspicious of their abuse of medical services and
sick leaves. The misunderstanding will break the mutual trust and respect in
doctor-patient relationship. Frequent consultation with no effective treatment is
simply wasting medical resources. It is a lose-lose situation : while we spend our
valuable medical resources, both doctors and patients are not satisfied. We have to
solve the problem from the root cause.
1.2.3 Innovation introduction
As a stress relieving exercise or complementary intervention, yoga becomes
increasingly popular among breast cancer patients globally. (H.Harder et al., 2012). It
is a low cost activity which requires only a yoga mat and limited space. It suits the
restricted living environment in Hong Kong. Apart from taking yoga class, home
practice also becomes feasible. Research pointed out that yoga is one of the most
commonly used complementary therapies for breast cancer because it improves
cancer related fatigue effectively (Fouladbakhsh & Stommel, 2010). With the
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convenience for practice and the beneficial effect provided, introducing a yoga
program can be anticipated as a feasible and sustainable practice for easing cancer
related fatigue. Thus, it is worthwhile to set up an evidence based yoga program for
relieving cancer related fatigue for female breast cancer patients.
1.2.4 Need of systematic reviews
Effectiveness of yoga in improving the quality of life has been a hot issue in
recent years. Emerging number of researches were carried out in past decades to
explore the effectiveness of yoga for breast cancer patients. Cancer related fatigue
was one of the hot aspects. Four related systematic reviews were obtained from the
searching databases (H. Harder et al., 2012) (Holger Cramer et al., 2011) (Julie Sadja
et al., 2013) (Laurien M Buffart et al., 2012). The studies ranged from 1990 to 2012.
They affirmed the effectiveness of yoga as complementary therapy providing positive
effect on physical and psychological aspects of female breast cancer patients,
including cancer related fatigue.
1.3 Objectives and Significance
1.3.1 Objectives
1 To conduct systematic literature searching on the effect of yoga in relieving
fatigue for female breast cancer patients
2 To evaluate the effect of yoga on the fatigue of female breast cancer patients
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systematically
3 To assess the feasibility, transferability and effectiveness of using yoga to relieve
fatigue of female breast cancer patients
4 To develop an evidenced-based nurse-led yoga training protocol for relieving
fatigue of female breast cancer patients
5 To develop the implementation and evaluation plan for the proposed nurse-led
yoga training protocol
1.3.2 Significance
Numbers of researches showed that yoga can improve cancer related fatigue for
breast cancer patients (Moadel et al., 2007) (Carson et al., 2009) (Suzanne et al.,
2009) (Alyson et al., 2010) (Jacquelyn et al., 2009) (Julienne, et al., 2012) (Holger et
al., 2011). Developing evidence based yoga therapy program can improve the nursing
management on female breast cancer patients. The program can help to build
nurse-patient trust and save medical resources in a cost-effective approach. As a
result, it improves the quality of care, nurse-patient relationship and leads to a better
allocation of resources so as to actualize a better clinical service. For the breast
cancer patients, through cancer related fatigue reduction, they can enjoy a better
quality of life so that they can return to their job and provide persistent contribution
to the society.
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Chapter 2 Critical Appraisal
After needs affirmation and stating the significance of developing an evidenced
based practice on yoga program to improve cancer related fatigue of female breast
cancer patients, this chapter will discuss related literature extracts and appraisal. It
includes the research strategies, research results and appraisal of selected researches.
Finally, synthesis and application of the selected papers will be discussed.
2.1 Search and Appraisal Strategies
2.1.1 Inclusion and exclusion criteria
Inclusion criteria for the research:
1) Participants are adult female breast cancer patients (age>18)
2) Intervention related to yoga
3) Fatigue is included in the outcome measurement with valid measuring tools
4) Literature with full text in English or Chinese
Exclusion criteria for research:
1) Systematic review
2) Participants received no treatment
3) Intervention makes effect of yoga not comparable
4) Participants with stage IV breast cancer
5) Participants with lymphedema
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2.1.2 Research strategy
Two databases were adopted for the research: PubMed (1950 - 2015) and
CINAHL PLUS (1982 - 2015). The research was carried out on 31-10-2015. Except for
experimental researches, four systematic reviews resulted. According to the PICO
structured research question, “breast neoplasm”, “yoga” and “fatigue” were
identified in relation of the elements of targeted participants, intervention and
outcome measures respectively.
Targeted participants: “breast neoplasm”
Intervention: “yoga”
Outcome measures: “fatigue”
Resulted papers were firstly screened by titles, abstracts and descriptions.
Papers fitted into inclusion criteria were identified. Besides, manual search by the
reference pages in the identified papers and systematic reviews were conducted.
2.1.3 Appraisal strategy
The Scottish Intercollegiate Guidelines Network (SIGN) checklist was adopted as
an appraising tool. It consisted of two sections which assess the internal validity and
overall quality of the selected study. Literatures would be ranked from 1++
(Meta-analysis, systematic review or RCT with high quality and low risk of bias) to 4
(Expert opinion) as the level of evidence by answering 14 questions.
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2.2 Results
2.2.1 Search Results
MeSH was adopted to ensure that the chosen keywords covered the possible
related wordings for literatures searching. It enhanced the comprehensiveness and
relatedness of the research result. Keywords adopted were “yoga”, “breast
neoplasm” and “fatigue”. Literature started with keywords combination of “yoga”
AND “breast neoplasm” AND “fatigue” in Pubmed and CINAHL PLUS. In Pubmed, 32
papers resulted and 13 papers were obtained from CINAHL PLUS. After screened by
titles, abstracts and descriptions, 14 papers remained for Pubmed searching and 3
for CINAHL PLUS. After removal of duplications, 14 papers obtained. In the remaining
papers, 8 papers were excluded as they were already adopted in the previous
literature reviews. Another paper was excluded as the participants were breast
cancer patients with lymphedema which was the exclusion criteria of the participants
of this program. As last, 5 papers were resulted for synthesis.
2.2.2 PRISMA flowchart
PRISMA flowchart of the searching procedure is attached in Appendix I.
2.2.3 Table of Evidence Description
The 5 resulted papers were carried out in China, USA and Taiwan. They covered
the participants of Westerners and Asians. Number of participants ranged from 52 to
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200 who were all females with breast cancer staging from 0-III. Participants were
taking yoga practice at least one year before research. Yoga practice and routine
standard care were the main comparison in the 4 research papers. In the research
paper conducted by Naciye et al. (2015), comparison was made by yoga with aerobic
exercise and only aerobic exercise. Duration of yoga practice ranged from 6 weeks to
6 months. The content of intervention mainly composed of posturing and stretching,
breathing exercise, meditation and relaxation exercise. Measuring tools varied
between researches. Multidimensional Fatigue Symptom Inventory-Short Form 36
(MFSI-SF36), Fatigue Severity Scale (FSS) and Cancer Fatigue Scale (CFS) were
adopted by different single paper while Brief Fatigue Inventory (BFI) was adopted by
two researchers (Taso et al., 2014) (Kavita et al., 2014). For effect size and statistical
power, all research papers showed fatigue improvement in intervention group. None
of the papers reported any adverse effect or increase in fatigue after completion of
intervention. The P-value of their outcome measures were mainly under 0.019
except the first set of data obtained by Wang, Jiang & Zeng (2014) which the P value
was 0.706. Table of evidence of individual papers were attached in Appendix II.
2.2.4 Summary of appraisal results
All selected papers were RCT which clearly addressed the research question :
whether yoga can improve the cancer related fatigue in female breast cancer
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patients. All papers stated clear description of the study design and intervention
contents. Randomization was carried out in all papers by different measures but only
3 out of 5 papers can provide adequate concealment method. No papers could
achieve blinding. For participants’ characteristics, 4 papers listed out the
socio-demographic and medical characteristics of participants and none of them with
unacceptable different in participants in two groups. Although the outcome
measuring tools are in high variety, all of them were valid and reliable. Most of the
dropout rates of the papers were in acceptable level (lower than 20%). Only one
paper complied with intention to treat as it had no dropout that all participants’ data
were analyzed. All researches were carried out in single site only. In general, all
studies provided acceptable measures to minimize bias. For the grading on the level
of evidence, Taso et al.’s (2014) and Janice et al.’s (2014)studies rated as 1++ and the
rest rated as 1+ level.
2.3 Summary and Synthesis
2.3.1 Summary of conclusions of selected studies
Among the 5 selected research papers, 3 of them were conducted in USA. Janice
et al. (2014) concluded that if yoga limits fatigue, regular practice could have
substantial health benefit. For the papers on comparison made other than standard
routine care, Naciye et al. (2015) concluded that yoga supported by aerobic exercise
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program can improve functional recovery and psychosocial wellbeing of patients. For
comparison between yoga and stretching exercise, Kavita et al. (2014) concluded that
yoga therapy improved quality of life and physiological changes better than simple
stretching exercise and the benefits seem to have long-term durability. For the 2
papers conducted in Asia, Taso et al. (2014) and Wang et al. (2014) concluded that
yoga intervention can reduce cancer related fatigue effectively. With different
comparisons and participants, 5 selected papers provided consistent evidenced on
the positive effect of yoga therapy in reducing cancer related fatigue in female breast
cancer patients.
2.3.2 Study results synthesis
Study design
All selected papers were randomized controlled trials with quality
randomization.
Subject characteristics
All papers recruited female breast cancer patients as the study participants.
Except Wang et al.’s paper (2014), all research studies provided socio-demographic
and medical data of participants. For the papers with socio-demographic data
provided, no significant difference between intervention group and control group
was shown. Kavita’s (2014) and Janice’s (2014) studies had a more comprehensive
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coverage of ethnic groups with black people, white people and Asian. In Kavita’s
(2014) paper, Latino was also included. The comprehensive coverage enhanced the
transferability of their studies. The participants in Naciye’s (2015 ) study were all
Caucasians. Taso’s (2014) and Wang’s (2014) only recruited their local Asian
participants.
For the sample size, Janice et.al (2014) recruited most participants among 5
papers with 100 participants in each group. Only 28 and 29 participants were
allocated in Naciye’s (2015) papers. The smaller sample size was, the lower the
reliability of the study resulted. Among 5 selected papers, only Taso et al. (2014) and
Janice et al. (2014) mentioned the statistical support and rationale for the sample
size. Both of them set their power at 0.8 and significance level (Alpha) as 0.05. The
effect size setting was based on the previous published studies.
Age of participants in all studies ranged from 20 to 70.
Three researches recruited participants with breast cancer staging from 0 to III
(Kavita et al., 2014) (Janice et al., 2014) or I to III (Taso et al., 2014). Naciye’s (2014)
study limited participants in breast cancer staging I to II with unilateral breast cancer
only. Breast cancer staging of participants was not mentioned by Wang et al. (2014).
For the treatment received by participants, Janice’s (2014), Kavita’s (2014) and
Naciye’s (2015) included wider coverage of cases whose participant were received or
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receiving radiotherapy or chemotherapy after surgery. It enhanced the transferability
of their studies. Taso’s (2014) and Wang’s (2014) papers included participants with
chemotherapy after surgery only while Kavita’s (2014) one only included participants
with radiotherapy after surgery. Janice’s (2014) study further excluded the
participants with history of cancer (including breast cancer) and patients having the
medication of tamoxifen or aromatase inhibitors.
Most of the papers set limits on exclusion criteria about the experience of past
yoga and exercise practice. Taso et al. (2014) set the strictest criteria that all
participants had no yoga experience. Janice’s (2014) and Wang’s (2014) papers
excluded participants with current yoga practice. Kavita’s (2014) study limited
participants to those not practising yoga throughout 1 year before the study. Naciye’s
(2015) paper had no limits on previous exercise practice experience due to the
contents of intervention and nature of comparison.
Intervention
The intervention content in the selected studies were similar : posturing or
stretching, breathing exercise, meditation and relaxation exercise except Naciye et al.
(2015). It compared the effect of yoga therapy by adding the yoga practice on the
same day of aerobic exercise session as an intervention program. Naciye’s (2015)
provided the most detailed intervention description (e.g.: name of yoga posture,
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duration of each posture to keep) among 5 papers. The result provides an evidence
support on the benefit of yoga on fatigue on top of aerobic exercise which further
strengthened the beneficial effect of yoga. However, no interventional content was
being provided in Janice’s (2014) paper.
The duration of intervention ranged from 6 weeks (Kavita et al., 2014) (Naciye et
al., 2015) to 16 weeks (Wang et al., 2014). They examined the short to medium term
effect of yoga on relieving cancer related fatigue in female brest cancer patients. For
frequency, 5 papers had high diversity which ranged from 4 days per week with 50
minutes per session (Wang et al., 2014) to 2 days per week with 60 minutes per
session (Taso et al., 2014). Wang’s (2014) study provided most intensive yoga therapy
training with 3200 minutes of yoga practice in the intervention. The interventional
yoga practice time of Taso’s (2014) paper was the least intensive among 5 papers
which only took 960 minutes.
In Janice’s (2014), Kavita’s (2014) and Wang’s (2014) studies, they provided
related materials (e.g. video or audio CD and practice manual) for participants’ home
practice and kept log of their practice progress. In Naciye’s (2015) and Taso’s (2014)
papers, no home practice record was provided.
In Kavita’s (2014), Taso’s (2014) and Wang’s (2014) intervention program, they
employed certified yoga instructors for designing the yoga practice and coaching
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participants. Kavita et al.(2014) adopted one to one coaching to ensure the quality of
the yoga practice. Janice et al. (2014) and Taso et al. (2014) adopted train the trainer
approach. Certified yoga trainers would train the instructors who provided coaching
to the participants. Naciye et al. (2015) invited physiotherapists with yoga training
certificate as the coaches of the yoga program.
Controls
Among 5 selected papers, 3 of them adopted standard care or usual activities as
control (Taso et al., 2014) (Janice et al., 2014) (Wang et al., 2014) for comparison. For
Kavita et al.’s (2014) research, there were two control groups. One of them named as
waitlist group that participants would receive usual care. Another group was
stretching group. Participants would perform exercises that were specifically
recommended for female breast cancer patients who were undergoing breast cancer
treatment. The comparison provided information on the advantage of yoga therapy
over other kinds of exercise program. In Naciye et al.’s (2015) study, both groups of
participants performed aerobic exercise. For the intervention group, yoga practice
was added in extra in the program for the participants. Additional beneficial effect of
yoga which was on top of aerobic exercise performance could be examined. These 2
studies not only provided evidence on the positive effective of yoga on female breast
cancer patients but also examined the superiority of yoga over other exercise
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programs to reduce cancer related fatigue. As a result, a more comprehensive
evidence of effectiveness of yoga on reducing cancer related fatigue in female breast
cancer patients is being generated.
Outcomes
There was a high variety in outcome measuring tools. Janice et al. (2014)
measured fatigue by Multidimentional Fatigue Symptom Inventory-Short Form
(MFSI-SF). It consisted of 30 questions with a full mark of 120. The higher the mark is,
the greater the fatigue is. In the result, fatigue was not significantly lower after
treatment (p=0.019, 95% CI=-3.1 to -3.28). However, a positive effect was revealed at
the 3rd month after treatment (p<0.001, 95% CI=-4.2 to -1.4). Besides, Janice et al.
(2014) further explored the association between frequency of yoga practice and
fatigue. If the time of yoga practice is increased by 10 minutes per day, 1.7 points of
MFSI-SF decrease would be resulted in immediate post treatment measure (p=0.19)
and 2.8 points decease in 3 months after treatment measure. The additional
exploration examined and outlined the positive association of yoga practice and
fatigue.
In Taso’s (2014) paper, they adopted Taiwan version of BFI for participants’
better understanding. They listed the statistical power for the internal consistency of
the assessment tool. BFI was indicated with 0.96 Cronbach’s alphas (interference =
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0.95), 0.89 of test-retest reliability (interference = 0.091) for the severity. The
reliability and transferability of the measuring tool was proven. Data was being
collected at pretest, week 4, week 8 and post-treatment week 4. The fatigue
decreased with treatment time from 1.9 (p<0.001) at week 4 to -19.7 in
post-treatment week 4. It showed a significant positive effect of yoga program on
decreasing fatigue along with time with high statistical quality. For Kavita et al. (2014)
and Taso et al. (2014), they measured fatigue by Brief Fatigue Inventory (BFI). It
composed of 9 questions with each ranging from 0 to 10 marks. The higher the mark
is, the greater the fatigue is. The result from Kavita’s (2014) showed a great decrease
(mean = -0.725, p<0.05) in fatigue by comparison between yoga group and waitlist
group. However, for the comparison of yoga and stretching groups, there was no
significant difference (mean = 0.05, p<0.05).
Naciye et al. (2015) adopted Fatigue Severity Scale (FSS) as the fatigue assessing
tool. It consists of 9 questions rating from 1 to 7. The greater the mark is, the greater
the fatigue is. Significant fatigue is indicated by the mark greater than 36. The result
showed a decrease in FSS score between intervention group and control (mean = -4,
p<0.05) with statistical significance.
In Wang’s (2014) study, Cancer Fatigue Scale (CFS) was being used. It is made up
of 15 questions, each rating from 1 to 5. A higher mark indicates greater fatigue.
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Fatigue was being assessed at the 2nd, 4th and 6th episodes of chemotherapy of the
participants. The marks of CFS kept decreasing along with the intervention time and
the statistical significance was also increasing. The mark increased (mean = +0.57) at
2nd chemotherapy with statistical insignificant (p=0.706) while the mark dropped
(mean = -4.55) with highly statistical significance (P<0.001) at 6th chemotherapy.
As a brief conclusion, consistently, all 5 papers revealed the positive effect of
yoga on relieving cancer related fatigue in female breast cancer patients with
statistical significance.
Dropout rate
In the selected papers, 2 papers had fair dropout rate. In Kavita’s (2014) and
Naciye’s (2015) papers, dropout rate ranged from 15%-25% with most of them
gathered at about 22%. Low sample size was one of the major reasons to account for
the high dropout rate as each drop out case attributed to larger portion of total
sample size. In Janice et al.’s (2014) study, the dropout rates of intervention and
control group were 4% and 10% respectively. In Taso et al.’s (2014) studies, 0% of
dropout rate was reported. All recruited participants were receiving chemotherapy at
the same medical center with of the target setting of the paper may be the reason
behind the 0% dropout rate. The low dropout rate is one of the key factors of the
result reliability reported.
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Blinding
Because of the nature of the intervention, participants were inevitably aware of
their intervention. As a result, blinding was not applicable.
Randomization and masking
All papers took sufficient randomization measures to minimize allocation bias.
Janice’s (2014) provided the most detail description of the randomization process
and adopted multiple measures for bias minimization. They employed a data
manager for the randomization process who would not be able to have contact with
the participants. Participants were firstly stratified according to their cancer stage
and receiving radiation or not. Then, data manager would obtain block
randomization (6 per block) sequence from online randomization program for group
assignment. Participants were instructed not to disclose their group assignment to
any of the study personnel. The data collection questionnaires were administered
through computer and all technicians were blinded. The multiple measures with
detailed description enhanced the quality of randomization and masking to minimize
allocation bias. Kavita et al. (2014) randomized the participants according to their
characteristics (e.g. stage of breast cancer, time since diagnosis) by adaptive
randomization. Taso et al. (2014) adopted computer generated number in opaque
envelops for random assignment. The randomization and assignment process were
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conducted by an independent staff who would not further participate in the
subsequent process of the study. Naciye et al. (2014) randomized participants with
sealed random envelops by independent staff. Wang et al. (2014) just simply
mentioned their randomization method as random number table without further
elaboration or other measures. It weakened the reliability of the randomization
quality which was key factor of bias minimization.
Other methodological quality
No studies applied intention to treat. All missing data, if any, was excluded from
analysis which affected the quality of the result. Selective reporting and unreported
outcomes were not noted. In Wang et al.’s research (2014), intervention and control
group were situated in different ward to prevent cross contamination of participants
which enhanced the reliability of the result.
2.3.3 Evidence support conclusion
In the 5 selected papers, two of them rated as 1++ (Taso et al., 2014) (Janice et
al., 2014). These 2 papers generated significant results with quality methodology and
analysis including sample size analysis with statistical support, quality randomization
and concealment, low dropout rate and demographic data analysis. The 2 papers
produced detailed explanation on their results and low risk of bias was noted.
Another 3 of the selected papers rated as 1+ (Kavita et al., 2014) (Naciye et al.,
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2015) (Wang et al., 2014). Although they showed significant results in measured
outcome, they did not prove their sample sizes were sufficient statistically and their
dropout rates were high. In Wang’s (2014) paper, no detailed description of
randomization process and measures were provided.
The SIGN appraisal checklists of individual papers were attached in Appendix III.
With reference to the outcomes and appraisal results, the selected papers
provided adequate evidence on adopting yoga program to reduce cancer related
fatigue in female breast cancer patients to support the thesis.
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Chapter 3 Implementation Potential and Clinical Guideline
This chapter will focus on the consideration of implementation potential based
on the reviewed literatures. To assess the implementation potential, examination of
several issues related to transferability, feasibility and cost-benefit ration are needed.
This chapter will compare the similarities and differences between the innovation
and reviewed literatures to assure the possibility of implementation.
3.1 Transferability
3.1.1 Target Setting
The targeted clinical setting for innovation implementation will be family clinics
in Department of Health. In Hong Kong, there are 5 family clinics. In the coming years,
there will be two more clinics as a response to the increasing services need. Family
clinic is one of the service units of Professional Development and Quality Assurance
(PDQA). It provides primary care service to civil servants, their dependents and the
pensioners. Service scope mainly includes medical consultation, minor surgery,
specialties referral, immunization and health education and promotion. Each clinic
will schedule nurse-led support group on regular basis to provide quality health
education to clients in small group basis. For service enhancement, except the
current services (e.g. hypertension, diabetic mellitus and weight control),
department seeks for service diversity to cover more comprehensive service need.
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3.1.2 Philosophy of care
The mission of the Department of Health is safeguarding the health of the
people of Hong Kong through promotive, preventive, curative and rehabilitative
services as well as fostering community partnership and international collaboration.
Proposed innovation is a part of the rehabilitative program to empower the self-care
ability of patients to relieve symptom and restore health.
Implementing health promotional plan of the department and developing
guidelines to practise evidence-based health care are two of the departmental
objectives of the targeted clinical setting. Proposed innovation is a health
promotional program. Trained nurses will conduct yoga programs to targeted clients
decrease cancer-related fatigue and encourage continuous self-practice for
substantive benefit. It aims at health restoration by a nurse-led health promotional
group. The innovation was being developed in evidence based manner. As a result,
the philosophy of care of the innovation and the organization of targeted setting is
well matched. Innovation could be therefore anticipated to receive well support from
the organization.
3.1.3 Target population
Breast Cancer Registry Report No. 7 in 2014 showed that breast cancer has
become the top female cancer killer in Hong Kong since 1993 (Hong Kong Cancer
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Registry, 2014). The median age of patients is 54 with decreasing trend (Hong Kong
Cancer Registry, 2014). In family clinics, there is an increasing number of female
breast cancer patients. The mean age of the female breast cancer related fatigue
patients is 52 , which matches the mean age in Hong Kong. They seek medical
consultation frequently for cancer related fatigue which affects their daily lives. The
population of female breast cancer patients who are attending family clinics is not
high. In 2015 family clinics statistics, 5 family clinics served 246064 consultations.
Breast cancer patient consultations contributed about 2% (4921) to the total
consultations. Among those related consultations, about 80% (3937) of them were
about cancer related fatigue. For each clinic, they have to serve 875 female breast
cancer related fatigue cases per year. The above figures were increasing. Although
the number of patients benefited seems to be limited, innovation can prevent the
deterioration of the problems. Repeated consultations on relieving such fatigue
ruined the harmony and trust between doctors and patients. It impaired staff morale
and aroused patients’ complaints. More and more cancer related fatigue patients will
sure further increase the medical burden and hinder the optimization of medical
resources allocation. Proposed innovation is a low cost and evidence-based solution
to ease the situation.
From the 5 selected research papers, Asian population was included in most of
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the studies. Although Janice’s (2014) and Kavita’s (2014) studies were conducted in
USA, they included 3% and 4% of Asian participants in the studies. Naciye’s (2015)
did not mentioned about the ethnicity. Wang’s (2014) and Taso’s (2014) papers were
conducted in China and Tai Wan which all participants were Asians (Chinese and
Taiwanese).
In Wang’s (2014) studies, they did not provide detailed demographical data.
They included participants aged from 18-60 as inclusion criteria. For Naciye’s (2015),
Kavita’s (2014) and Janice’s (2014) papers, the mean ages of their participants were
48.6, 51.9 and 51.6 respectively. In Taso’s (2014) studies, 66.6% of their participants
age from 41-60 with 21.7% aged below 40. All participants included in the 5 papers
were female patients.
The ethnicity, age and sex between the selected studies and the target
population showed no significant discrepancy. The positive results of the selected
literatures are therefore being considered as highly transferable to local application.
3.1.4 Innovation Period
In the 5 selected studies, Kavita’s (2014) and Naciye’s (2015) conducted their
intervention for 6 weeks. Janice’s (2014) intervention lasted the longest among 5
studies, it took 24 weeks to complete. For the Asian based studies, Wang’s (2014)
and Chao’s (2014) took 24 weeks and 8 weeks for their intervention respectively.
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The mean time of intervention for the 5 papers is 12 weeks. With consideration that
prolonged interventional period may cause higher cost and drop out due to loss of
participants’ concentration and compliance, interventional period is set as 6 weeks
for a better balance between cost and benefit.
The innovation period will be divided into 3 stages lasting for 9.5 months in total.
The first stage will be preparatory stage. It takes 6 months for interventional
preparation (e.g. train-the-trainers by licensed yoga therapist, yoga program content
design, DVD and log book productions, and procurement of yoga mattresses). The
interventional yoga program will last for 1.5 months in stage 2. Follow up data
collection, data analysis and program evaluation will be conducted in stage 3 lasting
for 2 months.
3.2 Feasibility
3.2.1 Staff
It is a nurse-led innovation in which nurses exercise the ultimate autonomy.
Nurses can initiate and terminate the intervention according to the situation (e.g.
environmental safety, manpower allocation) and patients’ conditions (e.g. medical
condition, mental status) at any time.
In current policy, 1000 clients per year is one of the appraisal criteria that each
registered nurse in Department of Health has to fulfill. In other words, conducting
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health educational program is the duty of each nurse in Department of Health. In
family clinics, leading a support group is one of the nursing educational programs. In
support groups, nurses will provide health education via a lecture together with
educational activities (e.g. physical exercise, games). The format of the proposed
innovation is similar to the nature of current practice of support group. As a result,
nurses are anticipated to be familiar with the format to conduct the proposed
innovation as a new support group topic. Innovation implementation should not
cause high degree of interference to the current staff function.
After massive retirement and service expansion, the ratio of junior nursing staff
is increasing with nearly all of them are degree or master holders. Comparatively,
higher educated nurses are more adaptive and motivated to welcome the clinical
change with evidence-based support. For senior staff, it is anticipated they are more
reluctant to the proposed innovation as they may not be familiar with knowledge of
yoga and not capable of demonstrating yoga to patients. To relieve the worries, we
have to introduce the roles and duties that nurses play in this innovation. Throughout
the program, nurses are not required to make perfect postural demonstration to
patients. The main duty of nurses is to ensure patients’ safety throughout yoga and
their willingness to particpate. During the yoga class, patients will learn to perform
yoga posture from the demonstrative video which was designed and recorded by
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licensed yoga trainer. Nurses will assess and amend patients’ postures for injury
prevention and benefit maximization. To realise their roles, 5 nurses will attend the
train-the-trainer session during office hours alternately on 2 separate days. They will
be well equipped with the knowledge of yoga and the cautious key points of the
postures in the yoga program. The trained nurses will provide training sessions to the
rest of the nurses to ensure all nurses will be able to conduct the innovation with
good quality. After training session, nurses will be well equipped and able to
participate in the innovation.
3.2.2 Organization
Currently, hypertension, diabetics mellitus and weight control are the topics of
support group in family clinics. In manpower allocation aspect, proposed innovation
is just a new topic under the same support group service. It does not involve
manpower expansion or reallocation. Therefore, implementation will not cause high
degree of interference to the manpower allocation but only 5-hour official release for
each staff for training.
In recent years, PDQA has been seeking new topics for service expansion.
Proposed innovation will not only provide service expansion scope to department
but also maximize service resources allocation by providing evidence-based service
to meet the actual needs of clients. As a result, organization is anticipated to support
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the implementation of the nurse-led innovation.
3.2.3 Skills, equipment and facilities
For successful implementation, software and hardware assessment is a must. In
family clinics, there is a function room for conducting health education in group (e.g.
support group, smoking cessation reunion). The function room is about 700 square
feet which is spacious enough for 5-7 clients to perform yoga at the same time.
Function room is well equipped with video, computer and public address (PA) system
for educational and tutoring purposes. In case clients forget to bring their own yoga
mats yoga lesson, clinics will have 5 in reserve for loan, which is the only setup cost
for the program in equipment and facilities aspect.
In software aspect, well equipped nurses with yoga knowledge is a must.
Licensed yoga trainers will provide related training to nurses. It includes basic yoga
knowledge, patients’ preparation and limitation for intervention, patients’ condition
assessment and monitoring, details of designed yoga program, correct postures of
yoga, injury prevention, participation motivation and outcomes evaluation. Nurses
are not required to perform the yoga postures but provide help and assist clients to
perform yoga postures correctly. Therefore, nurses need not worry about their
physical ability to conduct the program.
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3.2.4 Measuring tool
Outcome measurement focuses on cancer related fatigue. To evaluate the effect
of the innovation effectively and efficiently, Brief Fatigue Inventory in Taiwan version
(BFI-T) (Appendix IV) will be adopted as measuring tool. In the selected papers,
Kavita’s (2014) and Tsao’s (2014) adopted BFI as their measuring tool to evaluate the
effect of their interventions. The tool was designed by Mendoza et al. (1999). The
Taiwan version was established by Lin et al. (2006). It is a set of questionnaire which
consisted of 9 simple questions with each of them rated from 0 to 9 marks. It is a
comprehensive measuring tool that not only assesses the severity of the fatigue, but
also the extent to which fatigue interferes with patients’ daily life.
BFI-T is the translated version of the questionnaire from English to Chinese. To
ensure BFI-T can assess the cancer-related fatigue of Chinese iterated people
effectively, evidence-based evidence is needed. In Lin’s (2006) paper, the validation
of Taiwanese version of BFI was examined. Internal consistency was proved to be of
good quality by Cronbach alpha coefficients (n=0.96). Karnofsky Performance Status
(KPS) is a measuring tool to measure the ability of cancer patients to perform
ordinary tasks. In the validation study, the score of KPI and BFT-T showed a positive
relation. It proved the known-group validity is good. The convergent validity was well
proven by high correlation between BFI-T and the fatigue and vigor subscale of the
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Profile of Mood Status (POMS), a psychological rating scale of mood status. With the
significant change of BFI-T score across different chemotherapy stages, high
sensitivity was proven. Besides, the psychometric properties of BFI-T were highly
consistent with English version of BFI. To conclude, it is a clinically easy-to-use
measurement of cancer related fatigue with excellent reliability, validity and
sensitivity.
3.3 Cost-Benefit Ratio
3.3.1 Risk to clients
In the 5 selected literatures, no patients’ risk discussion or adverse reaction was
reported. However, risk of injury and physical intolerance were spotted. Nurses are
well trained for ensuring proper yoga postures performed and patients’ condition
assessment and monitoring. Besides, emergency trolley with medical backup by clinic
is always ready to minimize the effect of ad-hoc unfavorable condition.
3.3.2 Risk of maintaining current practice
In current practice, breast cancer patients seek repeated medical consultation
for their cancer-related fatigues. However, from medical officers’ point of view,
cancer related fatigue it a symptom but not an illness which does not need any
medical treatment or consultation. As a result, they will commonly prescribe
hypnotics for rest, nurses counselling and sick leaves. Indeed, the prescription is
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insufficient for symptom treating. Patients keep seeking medical consultation
repeatedly. It induces doubt on the quality of medical services and confidence in
medical officers, at the same time, medical officers will suspect patients for abusing
sick leaves. Trust between medical officers and patient is therefore broken. Conflicts
and complaints are resulted. It increases workload and impairs staff morale. Besides,
repeated medical consultation leads to wastage of treasurable and limited medical
resources.
3.3.3 Potential benefit
Proposed innovation can enhance service quality by providing an
evidence-based solution to alleviate cancer-related fatigue of breast cancer patients
effectively. The image and status of PDQA can therefore be improved. As the
cancer-related fatigue eased, repeating symptom-related consultation can be
reduced. Medical resources consumption can be maximized due to wastage
prevention. Besides, related conflicts, complaints and unnecessary workload will
decrease. Rapport between patients and medical staff can be well preserved. Staff
morale is therefore well boosted.
3.3.4 Setup cost
To ensure high quality patients’ condition monitoring, injury prevention and
preserving acceptable workload for nurses, the setup of yoga class will be in small
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class basis which only consist of 6 participants only. In preparatory state, employing
licensed yoga trainer for training and content design will be the largest portion of the
total setup cost. For nurses training, 5 nurses will be selected to participate the
training session which lasting for 5 hours each (HKD $8750). The 5 trained nurses will
be the trainers to well equip the rest of their nursing colleagues for the yoga
coaching technique. Besides staff training, the yoga trainer will design the yoga
program with demonstration for videotaping (HKD $5000). Equipment for
videotaping is available in clinic (HKD $300). To encourage continuous home practice,
patients are advised to buy their own yoga mats for lesson. However, 6 spare yoga
mats will be acquired (HKD $330) in case patients forget to bring theirs for the class.
Training manuals will be provided for each nurse (HKD $50).
For innovation implementation, participants will receive a DVD for home
practice (HKD $9) and log book for progress record (HKD $60). To evaluate the
effectiveness of the program, patients will complete the questionnaire of BFI-T in 3
moments: before innovation, after innovation and 3 months after innovation (HKD
$18). Evaluation form for program arrangement and teaching quality will be
delivered in the last lesson (HKD $3). Existing staff ($912) and venue ($6000) will be
used for the intervention.
To summarize, the total setup cost will be $22208 which included the running
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cost for 1 interventional group with evaluation already.
Maintenance cost is composed by DVD production and the printing cost of
evaluation form, BFI-T and log books. Venue and equipment maintenance cost are
excluded as the maintenance will be responsible by Architectural Service Department
(ASD) and Electrical and Mechanical Service Department (EMSD). As a result, the
total maintenance cost for the 1 class with 12 lessons will be HKD $6993.
Detail budgeting table is enclosed in Appendix V for further reference.
3.4 Evidence-Based Practice Guideline
To develop an evidence-based practice guideline, a review of related literatures
was conducted. Literatures resulted in search engines of Pubmed and CINAHL PLUS
generated a total of 45 papers. After removal of duplications, application of exclusion
criteria and systematic review exclusion, 5 randomized controlled trials papers
remained. (Appendix I & VI) Selected literatures were appraised by The Scottish
Intercollegiate Guidelines Network (SIGN) checklist to assess the internal validity and
overall quality with satisfactory result obtained. Among the selected papers, 3 of
them were ranked as “+” and 2 of them ranked as “++”. (Appendix III) After extraction
of details in selected literatures, table of evidence (TOE) was synthesized. (Appendix
II) TOE enhanced decision making in setting up the concrete evidence based
guideline by comparison of details among selected literatures was done.
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Details of evidence-based practice guideline is enclosed in Appendix VII for
further reference.
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Chapter 4 Implementation Plan
After transferability and feasibility affirmation, detail implementation plan has
to be worked out for systematic and efficient application of the innovation. The
implementation plan includes communication plan, pilot study plan, evaluation plan
and the basis for implementation.
4.1 Communication Plan
Effective communication with stakeholders is one of the key successful factor for
the implementation of innovation. A well planned communication plan can provide
detail information of the proposal to let the stakeholders to have well understanding
of the innovation.
4.1.1 Identify Stakeholders
The stakeholders of the innovation involved multidisciplinary aspects:
administrators, frontline health care providers, trainers and targeted patients.
Administrators
Administrators include nursing officer (NO) in-charge of the clinic, senior
medical officer (SMO) in-charge of the clinic, senior nursing officer (SNO) of the
service department and consultant of the service department. They are the
determinative persons to approve the implementation of the proposed innovation as
they are the manpower, funding and resources allocators. Besides, administrators
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can liaise to coordinate resources planning for the innovation and provide
administrative opinion for innovation enhancement. To consider the feasibility of the
innovation, administrator focuses on the aim, risk, cost and benefits of the
innovation which should be clearly addressed for innovation approval.
Frontline Health Care Providers
In frontline level, medical officers and nurses are the key stakeholders. Medical
officers will coordinate the implementation of the innovation by case screening,
detail assessment and referral to innovation. They mainly concerns about the aim of
innovation, benefits to clients, resources consumption and workload increment.
For nurses, they are the key stakeholders in the innovation clinically as they play
the vital role in the whole innovation: planning, preparation, co-ordination,
implementation and evaluation of the innovation. As a result, they will concern on
the workload increment, difficulties encountered in implementation and requisition
of required skills.
Yoga Trainer
Yoga trainer will provide adequate training to the nurses, design the appropriate
content of the yoga program and formulate risk identification protocol. The protocol
helps to identify the inappropriate physical conditions for yoga for risk management.
The concerns of yoga trainer mainly fall on the need of targeted recipients, the
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appropriateness of yoga content and the rewards
Targeted Patients
Targeted patients will be adult female breast cancer patients with cancer related
fatigue (CRF). They are the program recipients and key beneficiaries of the innovation.
They show concern on the cost, risk and benefit of the innovation.
4.1.2 Communication Pathway
Communication plan will adopt ascending approach. Innovation will be
proposed and discussed with the most influential stakeholders, the administrators,
for approval and funding. A proposal draft will be presented to nursing officer
in-charge and senior medical officer in-charge in clinic meeting to gain preliminary
opinion for innovation enhancement and approval. After that, presentation will be
escalated to the quarterly senior staff meeting. Presentation to be conducted in
senior staff meeting will be sent through senior medical officer (SMO) in-charge of
the clinic to the consultant of the service department. Before presentation in senior
staff meeting, the PowerPoint file with proposal files will be sent to all related parties
who will participate in the senior staff meeting. They include all the targeted
administrators of the innovation for preliminary study. Presentation in the meeting
will focus on the present clinical situation, limitation of current practice, related
literatures of innovation, risk and cost of the innovation and the expected benefits of
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the innovation to the service. After the presentation, discussion will be initiated for
exploring clinical feasibility. Questions and opinions will be consolidated for further
enhancement. Along with the stages advancement of the innovation, progress report
will be presented to the influential stakeholders in quarterly senior staff meeting to
keep communication and the whole process open and transparent. Communication
channel will be sustained through emails and progress presentation.
When approval is obtained, quotation requests will be sent by executive officer
(EO) to look for a suitable yoga trainer. Meeting will be arranged to introduce the
innovation and the job requirement to the trainer. Draft and feedback of yoga
program content and risk identification protocol will be discussed through emails.
Meeting will be arranged whenever necessary for demonstration and discussion.
Continuous communication will be achieved by emails and phone calls, if necessary.
After yoga program and risk identification protocol are established, a seminar
will be provided to medical officers and nurses in clinic for detailed introduction to
the innovation which focuses on the implementation and training. In the seminar,
question-and-answer session will be arranged to clarify immediate queries,
anticipated difficulties and misunderstanding. Health care providers are encouraged
to provide suggestions or queries by any means (e.g. emails, informal meeting,
written form) after the seminar in order to sustain a convenient and continuous
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communication for program enhancement. All questions and opinions will be
consolidated and reverted in regular monthly clinic meeting.
4.2 Pilot Study Plan
4.2.1 Feasibility of implementation
Anticipated feasibility was being explored based on the current situation and
obtained literatures in chapter 3. However, to ensure the actual feasibility of the
innovation, pilot study is the best solution.
The aim of the pilot study is to examine the difference between the estimation
and the execution of the program. Pilot study can provide valuable experience for
enhancement in order to improve the innovation. The study will examine subject
recruitment, implementation, evaluation, data collection and general feasibility of
the program. After pilot study, difficulties and opinions will be collected for
innovation modification.
Main objectives of pilot study are to:
1) Identify potential problems and difficulties of the innovation in subject
recruitment strategies, maintaining participation rate and data collection
2) Examine the feasibility of the innovation
3) Feedback collection from different stakeholders for further enhancement
Target enrollment size will be 8 participants. Three trained nurses will coordinate
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to conduct the pilot scheme according to the proposed protocol alternately.
Appendix IX presents the flow of the pilot study scheme.
4.2.2 Subject Enrollment
Recruitment of participants will be conducted under the framework of inclusion
and exclusion criteria of the protocol. Targeted capacity of participants will be 8
patients. Potential participants will be referred by doctors when they come to have
medical consultation. Nurses will provide the details of the innovation to the referred
patients. Patients will be enrolled after verbal consent obtained. Nurses will record
the difficulties encountered in the enrollment process for further enhancement. The
flow of case recruitment can be referred to in Appendix X.
4.2.3 Action Plan
A 2-hour introductory workshop will be arranged for 3 nurses to introduce
details of the innovation. After that, they will participate in a 5-hour yoga training
workshop. Licensed yoga trainer will introduce the basic yoga knowledge, content of
the yoga program and precautions in conducting a yoga training lesson. When
patients recruitment is completed, trained nurses will start the yoga training program
for 6 weeks. The details of the yoga training program can be referred to in Appendix
XI.
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4.2.4 Data Collection and Instrument
Except for demographical data, the primary data collected from the pilot
scheme will be the BFI-T score of pre-test before starting of the yoga grogram,
post-test after program end immediately and post-test at 4 weeks after the program.
Collected data will be input in Statistical Package for Social Science (SPSS) for
statistical analysis. Besides, dropout rate, if any, and staff satisfactory score
(Appendix VIII) will be collected and analyzed.
4.2.5 Evaluation of the Pilot study
Evaluation is based on 2 sources of information.
Statistical report can provide the information on the program impact on
program provider (nurses) and recipients (participants). Improvement in CRF as
indicated by the score in BFI-T is anticipated.
Collected comments can provide the direction to streamline the logistics and
resources allocation in perfecting the innovation. Enhancement meeting will be held
monthly with related stakeholders if necessary.
4.2.6 Pilot Study Timeline
The pilot study takes 9.5 months. The preparatory stage will last for 6 months. In
this stage yoga trainer will design the program content and then offer a 5 hours’
training for the 3 selected nurses. At the same time, documents necessary for the
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program will be well prepared. The yoga intervention will last for 6 weeks and 2
months for data collection and analysis. The 4 nurses (researcher and 3 trained
nurses) will take turn to maintain the smooth running of the pilot study.
4.3 Evaluation Plan
The aim of the evaluation plan is to assess the effectiveness of the innovation. It
includes identification of evaluation targets, sample size calculation and outcome
evaluation of different parties in the innovation.
4.3.1 Identification of Evaluation Targets
The key objective of the evaluation is to ensure every stakeholder can get their
anticipated benefits. The evaluation targets are therefore identified as the patients
(innovation recipients), health care providers (innovation providers) and the system.
4.3.2 Sample Size Calculation
The sample size of the innovation should be calculated in statistical method to
obtain the significant change result. In the reviewed literatures, only two papers
(Kavita, 2014)(Tsao, 2014) used Brief Fatigue Inventory (BFI) as the assessment tools.
Regretfully, Kavita’s (2014) paper did not mention the sample size calculation.
Therefore, sample size calculation will be based on Tsao’s (2014) paper. One-sample t
test will be performed by Piface, an online sample size calculator. In Tsao’s (2014)
research, it only listed out the standard deviations of experimental and control group
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at different data collection time. Therefore, standard deviation of change will be
calculated by the square root of the sum of standard deviation at pre-test and 4
weeks after intervention, which is, 7.7078. In Tsao’s (2014) paper, the mean of BFI in
pre-test dropped 10.7 marks to 5.4 in the post-test 4 weeks after yoga program,
hence, the true value for sample size calculation will be 10. With the power set as 0.8
and alpha equals to 0.05, the required sample size will be 6. For conservative
consideration, dropout rate will set as 20% and the required sample size will be 8.
4.3.3 Outcome Evaluation
The outcomes of the innovation are multidimensional. It provides
comprehensive information for innovation enhancement with high quality and
sustainability of the program. The outcome evaluation of the innovation includes 3
aspects: patients, health care providers and the system.
Patients
Clinically, patients are the core evaluation target as they are the beneficiaries of
the innovation. The CRF of the participants is expected to decrease after the
innovation. For assessment, BFI-T will be adopted.
Health Care Providers
Health care providers are responsible for the execution of the whole innovation.
Their comments are vital for innovation enhancement. Nurses are expected to gain
- 57 -
satisfaction, skills and knowledge via the innovation. For assessment, an anonymous
questionnaire will be used to assess nurses’ knowledge, self-perceived skills and
satisfaction. (Appendix VIII). Feedback and program enhancement will be announced
in monthly nurses meeting after nurses’ comments are collected.
System
System logistic determines patients’ experience, quality of intervention and staff
satisfaction which affect the effectiveness and sustainability of the program. For this
vital part, assessment should be comprehensive to cover different aspects. The
measuring outcomes include access of innovation, utilization of innovation, human
resources and cost of innovation. During recruitment, the access to innovation is
crucial. It will be evaluated by the number of participants being recruited from the
target group of patients.
The utilization rate of the innovation refers to the participation rate of the
enrolled patients in the yoga program. In each session of yoga class, class attendance
would be signified by participants’ signature. Definitely, the utilization of the
innovation will be affected by personal reasons or conditions (e.g. medical condition,
private affairs, individual time management), however, it can provide a reference on
general satisfaction of patients’ towards the innovation which is one of the successful
factor of the innovation.
- 58 -
For human resources allocation aspects, manpower and job duty will be
assigned as planned. In the anonymous questionnaire for nurses, workload and
general satisfaction will be assessed. Assessment will be conducted before the pilot
test and after the innovation for comparison. The feedback from the questionnaire
can reflect if the existing manpower allocation can meet innovation requirement.
Administrative stakeholders would commonly propose the minimum manpower for
cost-effectiveness. However, the workload of nursing staff is also important as staff
morale is one of the factors of the quality and sustainability of innovation. As a result,
adjusting the manpower allocation and workload by balancing the cost and morale is
vital.
The major cost of the innovation is the setup cost of the program including yoga
program content design and staff training by licensed yoga trainer. The real cost
should not far exceed the formulated budget plan and must be lower than the
funding provided by the department. The budget plan will be evaluated and
amended after pilot test.
4.3.4 Data Analysis
Statistical Package for Social Science (SPSS) will be adopted as the statistical
analysis tool. Demographic data (e.g. age, living district, marital status, educational
level) will be summarized by descriptive statistics. The effect of the intervention will
- 59 -
be analyzed by paired t-test with the scores of Brief Fatigue Inventory Taiwan version
(BFI-T). The mean scores of BFI-T obtained in pre-test, immediate after intervention
and 4 weeks after intervention show the effect of the yoga therapy on the primary
outcome: patients’ cancer related fatigue (CRF) level. It indicates the effectiveness of
the innovation. Besides, the paired t-test can be applied to the anonymous
questionnaire (Appendix VIII) to analyze the knowledge and satisfaction level of
health care providers. Questionnaire score before the pilot test and after the
innovation will be compared to assess the effectiveness of the training.
4.3.5 Evaluation Timeline
The main evaluation will be conducted for 10 weeks which is the period of
conducting the first yoga class of the program. After collection of analyzed data and
comments, enhancement meeting will be held monthly with related stakeholders if
necessary. Besides, evaluation meetings will be held half yearly to report the
progress, comments and enhancement to administrators and review the
effectiveness of the resources allocation for the innovation.
4.4 Basis for Implementation
The core effectiveness of the innovation is determined by primary outcome: CRF
of patients. It can be assessed by a well validated, easy-to-use and reliable
assessment tool: Brief Fatigue Inventory Taiwan version (BFI-T). With reference to the
- 60 -
reviewed literatures, the innovation is expected to decrease CRF of female adult
breast cancer patients. A successful criterion is set as mean BFI-T decreases 10 marks
after innovation.
In health care providers’ aspect, staff satisfaction and knowledge are the key
outcome assessment. It indicates the staff morale and self-perceived capability to
conduct the innovation, which are the key factors of innovation sustainability.
Well-planned training arrangement and continuous support will increase the
knowledge and satisfactory level of nurses as indicated by the anonymous
questionnaire (Appendix VIII). With comparison to pre-innovation, the mean
post-innovation questionnaire score decrease 20 marks is considered as successful
implementation.
For the whole system of innovation, successful implementation should be
indicated by enrollment rate and participation rate. More than half of the target
population enroll in the innovation and the participation rate of the innovation is
greater than 80% are two of the successful criteria which illustrate the demand of
the innovation.
Departmental budget is limited. The real cost of the innovation has to fall within
the estimated budget and lower than the approved funding for program
sustainability.
- 61 -
Chapter 5 Conclusion
Breast cancer is a fatal disease. Medical advancement lengthened the life span
of breast cancer survivors. The need of medical and nursing care from this population
is increasing. Cancer related fatigue is one of the most common symptoms
experienced by the breast cancer patients. The fatigue will impair their functional
level and quality of life. According to the literatures reviewed, yoga is an effective
solution to alleviate cancer related fatigue for breast cancer survivors.
Breast cancer patients can benefit from the proposed yoga program to decrease
their cancer related fatigue and regain better functional ability. It helps them to
resume to their social and family role for better contribution and self-image. For
health care providers, they can develop better practice in caring for breast cancer
patients by acquiring related knowledge and skills. On the health care system level,
the program can preserve patient-doctor rapport and maximize the allocation of
valuable medical resources by minimizing ineffective repeating consultations.
With the establishment of communication, pilot, implementation and
evaluation plans, the innovation provides a framework for success in the target
setting. Participation in the proposed yoga program is just the beginning, sustaining a
long term home practice will be the ultimate goal of the program. As a health care
provider, there is a hope that the implementation of the program will encourage the
- 62 -
breast cancer survivors to develop the habit of regular yoga practice which helps
them to lead a fatigue-free life with quality.
- 63 -
Appendix I PRISMA 2009 Flow Diagram
From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred
Reporting Items for Systematic Reviews and Meta-analysis: The PRISMA Statement. PLoS
Med 6(6): e1000097. Doi:10.1371/journal.pmed1000097
Records identified through Pubmed
(n=32)
Records identified through CINAHL PLUS
(n=13)
Records Screened
(n=14)
Records Excluded
(n=18) Records Screened
(n=3)
Records Excluded
(n=10)
Records after duplicates removed
(n=14)
Full-text articles assessed for eligibility
(n=5)
Studies included in qualitative synthesis
(n=5)
Full-text articles excluded
1 (∵lymphedema = exclusion criteria)
8(∵included in previous systematic reviews)
(n=9)
64
Appendix II Table of Evidence
Citation /
Design
(Study
Quality)
Sample Characteristics Intervention Control Outcomes
Measure
(Score Scale)
Effect Size
(Intervention – Control)
Chao-Jun
g Taso et.
al.(2014)/
RCT(++)
N=60, female
BC: stage I-III
Age 20-70
Receiving chemo.
No yoga practice
before
At least 1 month
after BC surgery
YG
N=30
8 wks, 2
days/wk, 60
mins/day
SC
N=30
Fatigue by BFI
(Taiwan
version)(0-90)
Pretest
0.7(p<0.001)
Wk 4
1.9(p<0.001)
Wk 8
-9.5(p<0.001)
4 wks after Tx
-19.7(p<0.001)
Janice
K.Kiecolt-
Glaser et.
al.(2014)/
RCT(++)
N=200, female
Age: 27-76
BC: stage 0-IIIa
Completed Tx 3 yrs
Completed
surgery/adjuvant
Tx/RT at least 2
months
No prior Hx of
cancer
No current yoga
YG
N=100
6 months, 2
days/wk, 90
mins/day
WL
N=100
Usual
activities
No yoga
practice
Fatigue by
MFSI-SF-36(36
-129)
Immediate post Tx
-1.7
SE=0.7
95% CI=-3.1 to -3.28
P<0.019
3 months post Tx
-2.8
SE=0.71
95% CI=-4.2 to -1.4
P<0.001
65
practice or previous
practice for >3
months
No vigorous
physical activity 5
hrs/wk
Kavita D.
Chandwa
ni et.
al.(2014)/
RCT(+)
N=163, female
age≧18, female
BC: stage 0-III
Before RT &
scheduled daily
adjuvant RT for 6
wks
No yoga practice 1
yr before
YG
N=35
Class +
home
practice: 6
wks, 3
days/wk, 60
mins/day
WL (usual care)
N=54
ST
N=56
Fatigue by
BFI(0-90)
End of Tx
YG:WL=-0.9(p<0.05)
YG:ST=0.2(p<0.05)
1 month after Tx
YG:WL=-0.6(p<0.05)
YG:ST=-0.2(p<0.05)
3 months after Tx
YG:WL=-1(p<0.05)
YG:ST=-0.1(p<0.05)
6 months after Tx
YG:WL=-0.4(p<0.05)
YG:ST=0.1(p<0.05)
Naciye
Vardar
Yağlı et.
al.(2015)/
RCT(+)
N=52, female
BC: unilateral, stage
I-II
Treatment
completed ≧3 yrs
Aerobic exercise
and yoga
N=24
6 wks, 3
days/wk, 30
mins/day
Aerobic exercise
N=28
Treadmill
for 6 wks, 3
days/wk, 30
mins/day
Fatigue by
FSS(9-73)
After training
-4.4(p<0.05)
66
Inactive
Age<60
No metastasis
Exercise
level:
60%-70% of
max. HR
Wang
Guofei et.
al.(2014)/
RCT(+)
N=100, female
Completed 1st dose
of chemo.
Age:18-60
Not practicing yoga
Yoga
N=50
4 months, 4
days/wk, 50
mins/day
RC&C
N=50
Fatigue by CFS
(Chinese
version)(0-60)
2nd Chemo.
0.57(p=0.706)
4th Chemo.
-3.49(p=0.004)
6th Chemo.
-4.55(p<0.001)
Footnote: BC = breast cancer, BFI = Brief Fatigue Inventory, CI = confidence interval, CFS = Cancer Fatigue Scale, Chemo. = chemotherapy, FSS = Fatigue
Severity Scale, HR = heart rate, Hx = history, max. = maximum, mins = minutes, MFSI-SF = Multidimentional Fatigue Symptom Inventory-Short
Form, P = p-value, RC&C = routine cure and care, RT = radiotherapy, SC = standard care, SD = standard deviation, ST = active stretching, Tx =
treatment, wks = weeks, WL = waitlist, yrs = years, YG = yoga
67
Appendix III SIGN Appraisal Checklists
Bibliography: Chao-Jung Taso et.al., 2014
Study Type: RCT
1.1 The study addresses an appropriate and clearly focused question.
Comment: PICO are clearly stated
Yes
1.2 The assignment of subjects to treatment groups is randomized.
Comment: Computer generated random number assignment
Yes
1.3 An adequate concealment method is used. Comment: Opaque envelope Yes
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Comment: Subjects cannot be blinded because of the nature of intervention.
Only investigators blinded
No
1.5 The treatment and control groups are similar at the start of the trial.
Comment: Socio-demographic data and medical characteristics were listed
out with no significant difference
Yes
1.6 The only difference between groups is the treatment under investigation. Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes(BFI, Taiwan
version)
1.8 What percentage of the individuals or clusters recruited into each treatment
arm of the study dropped out before the study was completed?
0%
1.9 All the subjects are analyzed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
Yes
∵all data was
being analyzed
1.10 Where the study is carried out at more than one site, results are comparable
for all sites. Comment: Study only carried out in one site.
Does not apply
2.1 How well was the study done to minimize bias?
Comment: sample size with power=0.8, alpha=0.05
and medium level of covariate’s R2=0.13, randomized
with concealment, single blind
Acceptable (++)
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the statistical
power of the study, are you certain that the overall
effect is due to the study intervention?
Yes∵supported sample size with 0%
dropout, P value of comparison <0.001
2.3 Are the results of this study directly applicable to the
patient group targeted by this guideline?
Yes. ∵only fatigue applicable and
patients receiving chemotherapy is part of
target group only
2.4 Notes. Summarise the authors’ conclusions. Add any
comments on your own assessment of the study, and
the extent to which it answers your question and
Author’s conclusion: 8 week yoga exercise
program effectively reduced fatigue.
Comment: It answered my question with
68
mention any areas of uncertainty raised above. similar nature of sample(Chinese), good
statistical power and 0% dropout
Level of Evidence 1++
Bibliography: Janice K. Kiecolt-Glaser et.al., 2014
Study Type: RCT
1.1 The study addresses an appropriate and clearly focused question.
Comment: PICO are clearly stated
Yes
1.2 The assignment of subjects to treatment groups is randomized.
Comment: Block randomization
Yes
1.3 An adequate concealment method is used. Comment: Data manager had no
participant contact and not allowed to mention assignment to others
Yes
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Comment: Subjects cannot be blinded because of the nature of intervention.
Only investigators blinded
No
1.5 The treatment and control groups are similar at the start of the trial.
Comment: Socio-demographic data and medical characteristics were listed
out with no significant difference
Yes
1.6 The only difference between groups is the treatment under investigation. Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes(SF-36)
1.8 What percentage of the individuals or clusters recruited into each treatment
arm of the study dropped out before the study was completed?
Yoga:4%
Waitlist: 10%
1.9 All the subjects are analyzed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
No
1.10 Where the study is carried out at more than one site, results are comparable
for all sites. Comment: Study only carried out in one site.
Does not apply
2.1 How well was the study done to minimize bias?
Comment: acceptable sample size (subjects=200) with
statistical power support, randomized with well
concealment, low dropout rate
Acceptable (++)
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the statistical
power of the study, are you certain that the overall
effect is due to the study intervention?
Yes∵statistical supported sample size
with low dropout, P value of comparison
<0.019, positive intervention increment
effect investigated
2.3 Are the results of this study directly applicable to the
patient group targeted by this guideline?
Yes.
∵only fatigue applicable and patients
completed treatment and unilateral
cancer are part of target group only
69
2.4 Notes. Summarise the authors’ conclusions. Add any
comments on your own assessment of the study, and the
extent to which it answers your question and mention
any areas of uncertainty raised above.
Author’s conclusion: Yoga practice
substantially reduced fatigue.
Comment: Good quality RCT to support
with positive intervention increment
effect shown.
Level of Evidence 1++
Bibliography: Kavita D. Chandwani et.al., 2014
Study Type: RCT
1.1 The study addresses an appropriate and clearly focused question.
Comment: Outcome not stated
No
1.2 The assignment of subjects to treatment groups is randomized.
Comment: Adaptive Randomization
Yes
1.3 An adequate concealment method is used. No (not mentioned)
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Comment: Subjects cannot be blinded because of the nature of intervention.
Only investigators blinded
No
1.5 The treatment and control groups are similar at the start of the trial.
Comment: Socio-demographic data and medical characteristics were listed
out with no significant difference
Yes
1.6 The only difference between groups is the treatment under investigation. Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes (by BFI)
1.8 What percentage of the individuals or clusters recruited into each treatment
arm of the study dropped out before the study was completed?
Yoga:19%
Stretch: 23%
Waitlist: 15%
1.9 All the subjects are analyzed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
No
1.1
0
Where the study is carried out at more than one site, results are comparable
for all sites. Comment: Study only carried out in one site.
Does not apply
2.1 How well was the study done to minimize bias?
Comment: small sample size (n=163), dropout rate in
control group is a bit high (stretch=23%>20%),
concealment not mentioned
Acceptable (+)
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the
statistical power of the study, are you certain that the
overall effect is due to the study intervention?
Fair certainty
∵small sample size, P value of outcome
measurement ranged from 0.56-0.03 but
P=0.04 in comparison of end of treatment
between intervention and waitlist
70
2.3 Are the results of this study directly applicable to the
patient group targeted by this guideline?
Yes.∵only fatigue applicable and patients
undergoing radiotherapy is part of target
group only
2.4 Notes. Summarise the authors’ conclusions. Add any
comments on your own assessment of the study, and
the extent to which it answers your question and
mention any areas of uncertainty raised above.
Author’s conclusion: Fatigue improved to a
greater extent among women in the yoga
group relative to women in the control
group
Comment: It answered my question but
insufficient statistical power
Level of Evidence 1+
Bibliography: Naciye Vardar Yağlı et.al., 2014
Study Type: RCT
1.1 The study addresses an appropriate and clearly focused question.
Comment: PICO are clearly stated
Yes
1.2 The assignment of subjects to treatment groups is randomized.
Comment: Random sealed envelope drawing
Yes
1.3 An adequate concealment method is used. Comment: Sealed envelope Yes
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Comment: Subjects cannot be blinded because of the nature of intervention.
Only investigators blinded
No
1.5 The treatment and control groups are similar at the start of the trial.
Comment: Socio-demographic data and medical characteristics were listed
out with no significant difference
Yes
1.6 The only difference between groups is the treatment under investigation. Yes
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes(FSS)
1.8 What percentage of the individuals or clusters recruited into each treatment
arm of the study dropped out before the study was completed?
Intervention: 20.8 %
Control: 25%
1.9 All the subjects are analyzed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
No
1.1
0
Where the study is carried out at more than one site, results are comparable
for all sites. Comment: Study only carried out in one site.
Does not apply
2.1 How well was the study done to minimize bias?
Comment: low sample size (n=52), fair dropout rate,
randomized with sealed envelope
Acceptable (+)
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the statistical
power of the study, are you certain that the overall
Fair
∵ fair sample size with no statistical
support, fair dropout but P value of
71
Bibliography: Wang Guofei et.al., 2014
Study Type: RCT
1.1 The study addresses an appropriate and clearly focused question.
Comment: PICO are clearly stated
Yes
1.2 The assignment of subjects to treatment groups is randomized.
Comment: Random number table
Yes
1.3 An adequate concealment method is used. Comment: Not mentioned No
1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.
Comment: Subjects cannot be blinded because of the nature of intervention.
Only investigators blinded
No
1.5 The treatment and control groups are similar at the start of the trial.
Comment: No socio-demographic data listed out
Not mentioned
1.6 The only difference between groups is the treatment under investigation. Can’t say
1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes(CFS, Chinese
version)
1.8 What percentage of the individuals or clusters recruited into each treatment
arm of the study dropped out before the study was completed?
Intervention: 20 %
Control: 16%
1.9 All the subjects are analyzed in the groups to which they were randomly
allocated (often referred to as intention to treat analysis).
No
1.10 Where the study is carried out at more than one site, results are comparable
for all sites. Comment: Study only carried out in one site.
Does not apply
2.1 How well was the study done to minimize bias?
Acceptable (+)
Comment: low sample size (n=100), fair
dropout rate, adequate concealment
effect is due to the study intervention? comparison <0.05
2.3 Are the results of this study directly applicable to the
patient group targeted by this guideline?
Yes.
∵only fatigue applicable and patients
receiving chemotherapy is part of target
group only
2.4 Notes. Summarise the authors’ conclusions. Add any
comments on your own assessment of the study, and
the extent to which it answers your question and
mention any areas of uncertainty raised above.
Comment: It provided evidence on yoga can reduce
fatigue on top of aerobic exercise which strengthens
the use of yoga as an intervention in my program.
Author’s conclusion: participation in
physical activity with interventions (e.g.:
yoga) in breast cancer patients is an
effective method for sustaining functional
capacity and QoL.
Level of Evidence 1+
72
method not mentioned , no
socio-demographic data
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the statistical
power of the study, are you certain that the overall
effect is due to the study intervention?
Fair
∵ fair sample size and dropout,
adequate concealment method not
mentioned but p value of comparison
<0.05
2.3 Are the results of this study directly applicable to the
patient group targeted by this guideline?
Yes∵outcome measure applicable,
patients receiving chemotherapy is part of
target group only with similar
characteristics (Chinese)
2.4 Notes. Summarise the authors’ conclusions. Add any
comments on your own assessment of the study, and
the extent to which it answers your question and
mention any areas of uncertainty raised above.
Author’s conclusion: Yoga intervention
could significantly reduce fatigue.
Comment: It answered my question with
similar nature of sample (Chinese) with
acceptable quality
Level of Evidence 1+
73
Appendix IV Brief Fatigue Inventory - Taiwan Version (BFI-T)
簡單的思考下面三個問題：
1. 你現在有任何累或疲憊的感覺嗎?
2. 如果有，從 0 到 10 分(0 分為完全不累，10 分為想像中最疲憊的狀態)找出一個適合描述您每天疲憊
狀態的分數。
3. 這樣的疲憊是否有影響您日常生活的機能(例如工作、家務等)。
您可透過「台灣版簡明疲憊量表測驗」來幫助自己了解癌因性疲憊症的現況與影響程度：
我們大多數人一生有時會感覺非常疲勞或勞累。
您最近一週內是否有不尋常的疲勞或勞累?
是 否
1. 請標記一個數值,最恰當的表示您現在的疲勞程度(乏力,勞累)
0 1 2 3 4 5 6 7 8 9 10
2. 請標記一個數值,最恰當的表示您在過去 24 小時內一般疲勞程度(乏力,勞累)
0 1 2 3 4 5 6 7 8 9 10
3. 請標記一個數值,最恰當的表示您在過去 24 小時內最疲勞程度(乏力,勞累)
0 1 2 3 4 5 6 7 8 9 10
4. 請標記一個數值,最恰當的表示您在過去 24 小時內疲勞對您下述方面的影響：
A. 一般活動
0 1 2 3 4 5 6 7 8 9 10
B. 情緒
0 1 2 3 4 5 6 7 8 9 10
74
C. 行走能力
0 1 2 3 4 5 6 7 8 9 10
D. 正常工作(包括外出工作和戶內家務)
0 1 2 3 4 5 6 7 8 9 10
E. 與他人關係
0 1 2 3 4 5 6 7 8 9 10
F. 享受生活
0 1 2 3 4 5 6 7 8 9 10
75
Appendix V Budgeting Table
Budget Plan Estimated Cost (HKD$)
Preparation
Nurses training by licensed yoga trainer
(1 session for 5 staff, 5 hours/lesson)
(5 staffs X 5 hours X $350/hour )
$9750
Training manual printing (10 X 10 pages X $0.5) $50
Yoga program design and demonstration $5000
Video Recording $300
Yoga mats (6 X $55) $330
Implementation (60 mins/lesson, twice/week for 6 weeks)
Venue cost (Function Room) $6000
Staff
(Hourly salary of an RN in average seniority ∴MPS 20)
$912
DVD production (6 X $1.5) $9
Log book printing (10 pages X 6 X $1 ) $60
BFI-T questionnaires printing
(Pre- and Post-intervention)
(2X 2 pages X 6 X $0.5 )
$12
Evaluation
Staff
(Hourly salary of an RN with average seniority ∴MPS 20) *4
$776
BFI-T questionnaires printing
(Post intervention 3 months)
(2 pages X 6 X $0.5)
$6
Evaluation Form printing (1 page X 6 X 0.5) $3
Total Setup Cost $22208
Maintenance cost / class (12 lessons) $6993
Note:
1) BFI-T = Brief Fatigue Inventory (Tai Wan version)
2) MPS = Master Point Scale
3) The above budget plan is for 6 patients / class
76
Appendix VI Table of Study Design
Studies Design
Janice, K.K., Jeanette, M.B., Rebecca, A., Juan, P., Charles, L.S., William, B.M…Ronald, G. (2014). Yoga’s Impact on
Inflammation, Mood, and Fatigue in Breast Cancer Survivors: A Randomized Controlled Trial. Journal of
Clinical Oncology, 32 (10), 1040-1049.
Randomized Controlled Trial
Kavita, D., Chandwani, George, P., Hongasandra, R.N., Nelamangala, V., Raghuram… Lorenzo, C. (2014).
Randomized, Controlled Trial of Yoga in Women With Breast Cancer Undergoing Radiotherapy. Journal of
Clinical Oncology, 32 (10), 1058-1065.
Randomized Controlled Trial
Naciye, V.Y., Gul, S., Hulya, A., Melda, S., Deniz, I.I., Sema, S… Yavuz, O. (2015). Do Yoga and Aerobic Exercise
Training Have Impact on Functional Capacity, Fatigue, Peripheral Muscle Strength, and Quality of Life in
Breast Cancer Survivors. Integrative Cancer Therapies, 14 (2), 125-132.
Randomized Controlled Trial
Taso, C.J., Lin, H.S., Lin, W.L., Chen, S.M., Huang, W.T. & Chen, S.W. (2014). The Effect of Yoga Exercise on Randomized Controlled Trial
77
Improving Depression, Anxiety, and Fatigue in Women With Breast Cancer: A Randomized Controlled Trial.
The Journal of Nursing Research, 22 (3), 155-164.
Wang, G.F., Wang, S.H., Jiang, P.L. & Zeng, C. (2014). Effect of Yoga on cancer related fatigue in breast cancer
patients with chemotherapy. Journal of Central South University (Medical Science), 39 (10), 1077-1082.
Randomized Controlled Trial
78
Appendix VII Implementation Guideline
Background
After affirming the implementation potential of the innovation, evidence based
protocol was established based on the selected literatures after critically appraisals. In this
chapter, synthesized protocol will be presented with description of target group,
recommendations and supportive evidences.
Title:
Evidenced-based yoga program in reducing cancer related fatigue among female breast
cancer patients
Target user
This protocol is aimed to support the nurses in family clinics to provide quality caring
and education on adult female breast cancer patients with cancer related fatigue.
Target group
This protocol covers adult (age>18) female breast cancer patients who seek medical
advices on breast cancer related fatigue in families clinics.
Evidence Based Recommendations
The following recommendations are derived from the review of 5 selected literatures.
1) Medical history of target group
Patients selected for the yoga program are suffering from stage 0 to III breast cancer
79
(Taso, 2014; Janice, 2014; Kavita, 2014; Naciye, 2015)
Evidence
In the selected literatures, 4 out of 5 included patients with stage 0-III breast
cancer. Comparing with stage IV breast cancer patients, stage 0-III patients
possess better physical fitness for yoga therapy. It can ensure sustainable
participation and home practice compliance.
2) Yoga practice history
Selected patients have no current yoga practice and the recent yoga practice was
more than 3 months before study(Taso , 2014; Janice , 2014; Kavita , 2014, Naciye ,
2015; Wang , 2014)
Evidence
This educational program aims at promoting sustainable yoga practice among
female breast cancer patients to reduce cancer related fatigue. Benefit
maximization can be reached by recruiting female breast cancer patients with no
regular yoga practice habit for better resources utilization.
3) Intervention period
Yoga program will last for 6 weeks with a twice a week schedule (60 mins per class)
(Janice, 2015, Kavita, 2014; Naciye,2015; Taso, 2014)
80
Evidence
The mean interventional period of 5 selected literatures was 6 weeks which is
sufficient to achieve beneficial effect. The target group of the yoga program
possesses the highest similarity in patients’ demographic characteristics with
Taso’s (2014) studies which achieved a high quality convincing supportive result.
Therefore, frequency is set as 60 mins per class for twice a week. Prolonged
interventional period and high frequency may led to decrease in participation
and increase in dropout rate.
4) Post-program evaluation
Post-program evaluation should be conducted 3 months after program. (Janice,
2014; Kavita , 2014)
Evidence
Cancer related fatigue level may be affected by individual condition and home
practice. From the review of selected literatures, 3-month is a reasonable time
period to obtain accurate and comparable outcomes for program evaluation.
5) Assessment tools
Brief Fatigue Inventory (Tai Wan version) (BFI-T) is adopted as the assessment tool to
examine the level of cancer related fatigue. (Kavita , 2014; Taso , 2014)
Evidence
81
For Taiwan version, traditional Chinese translation promotes better
understanding and more accurate answer of targeted Chinese patients. Besides,
BFI-T was proven with excellent reliability, validity and sensitivity by literature
(Lin, 2006) which is an effective and user friendly assessment tool.
6) Program content
Content of yoga program will be composed by warm up, yoga postures, breathing
exercise and meditation. (Kavita, 2014; Naciye, 2015; Taso, 2014; Wang, 2014)
Evidence
In the review of the selected literatures, 4 out of 5 possess the above content to
achieve the beneficial result effectively.
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Appendix VIII Questionnaire on Evidence-based yoga program for female
breast cancer patients
Instruction
Please circle the appropriate number to indicate your attitude to each statement.
Number Indication
1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
Knowledge Level and Self-perceived Skills
Question Statement Number
1 I understand the nature of breast cancer. 1 2 3 4 5
2 I understand the common treatments of breast cancer. 1 2 3 4 5
3 I understand the source of cancer related fatigue (CRF) 1 2 3 4 5
4 I understand the effect of CRF on patients’ daily live. 1 2 3 4 5
5 I am clear about the need for practicing yoga by breast cancer
patients.
1 2 3 4 5
6 I am clear about the risks, benefits and complications of the
innovation.
1 2 3 4 5
7 I understand the inclusion and exclusion criteria of the
innovation.
1 2 3 4 5
8 I developed the required skills for me to conduct the yoga
program successfully.
1 2 3 4 5
9 I understand the yoga postures, sequence, duration and
frequency of the innovation.
1 2 3 4 5
10 I understand the use of Brief Fatigue Inventory (BFI-T) to assess
patients’ fatigue level.
1 2 3 4 5
11 I am confident to provide detail explanation and instruction of
the innovation to patients.
1 2 3 4 5
12 I am alert to patients’ adverse reaction and difficulties during
the yoga program.
1 2 3 4 5
83
Satisfaction Level
Question Statement Number
13 I understand my expected role in the innovation. 1 2 3 4 5
14 The content of the program is well-organized to facilitate
teaching.
1 2 3 4 5
15 The duration of the innovation is appropriate. 1 2 3 4 5
16 The teaching materials are well prepared with clear instruction. 1 2 3 4 5
17 The assessment tool is easy to use. 1 2 3 4 5
18 The program workload is affordable. 1 2 3 4 5
19 Overall, I am confident in conducting the innovation. 1 2 3 4 5
20 Overall, I am satisfied with the innovation arrangement. 1 2 3 4 5
Other Comment
1) What are the difficulties in conducting the innovation?
2) What are the rooms for improvements of the innovation?
3) Other comments:
~~END~~
84
Appendix IX: Flow Chat for Pilot Study Scheme
Innovation Enhancement
Evaluation for Feeback and Comment Collection
4 Weeks Post-yoga Data Collection (BFI-T)
Immediate Post-yoga Training Data Collection (BFI-T)
Yoga Training for 6 weeks
Pre-yoga Training Data Collection (BFI-T)
Participants Recruitment (8 Patients)
Training Workshop for Three Nurses by Yoga Trainer
Program Preparation
(e.g.: Yoga program design, documents printing)
85
Appendix X: Case Recruitment Flowchart
Doctor • Breast cancer cases seek medical consultation in targetted
setting
Doctor
• Inclusion Criteria:
• Adult
• Female
• Breast cancer of stage 0 to III
• Experienced cancer-related fatigue
Doctor
• Exclusion Criteria:
• Currently practicing yoga (practice yoga last 3 months regularly for > twice/week)
• Lymphoedema
• Cognitive impairment
Doctor • Doctors will refer clients to nurses for Yoga program
introduction
Nurse
• Deatails of yoga program will be explained to referred patients
• Obtain Consent from patients
86
Appendix XI: Yoga program Flowchart
Lesson
1
• Pre-test
• Participants need to complete the BFI-T questionnaire as a pre-test
Lesson
1
• Nurses will spend 10 mins to introduce the details of the program as a reminder to participants
Lesson
1-12
• Yoga lesson
• 60 mins / lesson, Twice / week, Lasts for 6 weeks
• Content:
• Warm up
• Yoga Postures
• Breathing Exercise
• Meditation
Lesson
12
• Patrticipants need to complete the BFI-T questionnaire right after the lesat lesson as the first post test
• Participants are reminded to keep performing Yoga at home after the program
4 weeks after
• Phone follow-up will be conducted
• Frequency of Yoga performace in the last 4 weeks
• 2nd post-test: BFI-T
87
References
Alyson, J. L., Lisa, C.B., Rachel, C., Cornelia, M.U., Jaya, R., Bonnie, M. & Anne, M. (2012).
Randomized Controlled Pilot Trial of Yoga in Overweight and Obese Breast Cancer
Survivors: Effects on Quality of Life and Anthropometric Measures. Support Care
Cancer, 20 (2), 267-277.
American Cancer Society (2015). How is breast cancer staged?. Retrieved November 28,
2015 from
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-staging
Breast Cancer Network Australia (2015). Types of Breast Cancer. Retrieved November 28,
2015 from
https://www.bcna.org.au/understanding-breast-cancer/types-of-breast-cancer/
Buffart, L.M., Van Uffelen, J.GZ., Riphagen, I.I., Brug, J., Van Mechelen, W., Brown, W.J. &
Chinapaw, M. JM. (2012). Physical and psychosocial benefits of yoga in cancer
patients and survivors, a systematic review and meta-analysis of randomized
controlled trials. BMC Cancer, 12 (559).
Carlson, L., Angen, M., Cullum, J., Goodey, E., Koopmans, J., Lamont, L…Bultz, B.D. (2004).
High levels of untreated distress and fatigue in cancer patients. British Journal of
Cancer, 90, 2297-2304.
Carson, J. W., Carson, K. M., Porter, L. S., Keefe, F. J., Victoria, L. & Seewaldt (2009). Yoga of
88
Awareness program for menopausal symptoms in breast cancer survivors: results
from a randomized trial. Support Care Cancer, 17 , 1301-1309.
Fukuda, K., Stephen, E.S., Ian, H., Michael, C.S., James, G.D., Anthony, K. & International
Chronic Fatigue Syndrome Study Group (1994). The Chronic Fatigue Syndrome: A
Comprehensive Approach to Its Definition and Study. American College of Physicians,
121 (12), 953-959.
Fouladbakhsh, J.M. & Stommel, M. (2010). Gender, Symptom Experience, and Use of
Complementary and Alternative Medicine Practices Among Cancer Survivors in the
U.S. Cancer Population. Oncology Nursing Forum, 37 (1), 7-15.
Glaus, A., Crow, R. & Hammond, S. (1996). A qualitative study to explore the concept of
fatigue/tiredness in cancer patients and in healthy individuals. European Journal of
Cancer Care, 5 (2), 8-23.
Harder, H., Parlour, L. & Jenkins, V. (2012). Randomised controlled trials of yoga
interventions for women with breast cancer: a systematic literature review. Support
Care Cancer, 20, 3055-3064.
Holger, C., Silke, L., Petra, K., Anna, P. & Gustav, D. (2012). Can yoga improve fatigue in
breast cancer patients? A systematic review. Acta Oncologica, 51 (4), 559-560.
Hong Kong Breast Cancer Foundation (2015). Hong Kong Breast Cancer Registry Report
No.7. Retrieved December 1, 2015 from
89
http://www.hkbcf.org/download/bcr_report7/full_report_2015.pdf
Jacquelyn, B., Holly, W., Mel, H., Sally, E.B. & Robert, B. (2009). Effect of Iyengar yoga
practice on fatigue and diurnal salivary cortisol concentration in breast cancer
survivors. Journal of the American Academy of Nurse Practitioners, 23 (3), 135–142.
Janice, K.K., Jeanette, M.B., Rebecca, A., Juan, P., Charles, L.S., William, B.M…Ronald, G.
(2014). Yoga’s Impact on Inflammation, Mood, and Fatigue in Breast Cancer Survivors:
A Randomized Controlled Trial. Journal of Clinical Oncology, 32 (10), 1040-1049.
Julienne, E. B., Deborah, G., Beth, S., Patricia, A.G., Michael, R.I., Richard, O., & Gail, G.
(2012). Yoga for persistent fatigue in breast cancer survivors: A randomized controlled
trial. Cancer, 118 (15), 3766-3775.
Julie, S. & Paul, J.M. (2013). Effects of Yoga Interventions on Fatigue in Cancer Patients and
Survivors: A Systematic Review of Randomized Controlled Trials. Explore (NY), 9 (4),
232-243.
Kavita, D., Chandwani, George, P., Hongasandra, R.N., Nelamangala, V., Raghuram…
Lorenzo, C. (2014). Randomized, Controlled Trial of Yoga in Women With Breast
Cancer Undergoing Radiotherapy. Journal of Clinical Oncology, 32 (10), 1058-1065.
Lin, C. C., Chang, A.P., Chen, M.L., Cleeland, C.S., Mendoza, T.R., & Wang, X.S. (2006).
Validation of the Taiwanese Version of the Brief Fatigue Inventory. Journal of Pain and
Symptom Management, 32 (1), 52-59.
90
Mendoza, T.R., Wang, X.S., Cleeland, C.S., Morrissey, M., Johnson, B.A., Wendt, J.K., &
Huber, S.L. (1999). The rapid assessment of fatigue severity in cancer patients: Use of
the Brief Fatigue Inventory. Cancer, 85, 1186-1196. doi: 10.1002/(SICI)
1097-0142(19990301)85:5<1186::AID-CNCR24>3.0.CO;2-N
Minton, O. & Stone, P. (2008). How common is fatigue in disease-free breast cancer
survivors? A systematic review of the literature. Breast Cancer Res Treat, 112, 5-13.
Moadel, A. B., Shah, C., Wylie-rosett, J., Harris, M.S., Patel, S.R., Hall, C.B. & Sparano, J.A.
(2007). Randomized Controlled Trial of Yoga Among a Multiethnic Sample of Breast
Cancer Patients: Effects on Quality of Life. Journal of Clinical oncology, 25 (28),
4387-4395.
Mock V., Atkinson A., Barsevick A., et al. (2000). National Comprehensive Cancer Network.
NCNN practice guidelines for cancer-related fatigue. Oncology, 14, 151– 161.
Naciye, V.Y., Gul, S., Hulya, A., Melda, S., Deniz, I.I., Sema, S… Yavuz, O. (2015). Do Yoga and
Aerobic Exercise Training Have Impact on Functional Capacity, Fatigue, Peripheral
Muscle Strength, and Quality of Life in Breast Cancer Survivors. Integrative Cancer
Therapies, 14 (2), 125-132.
National Breast Cancer Foundation (2015). About Breast Cancer. Retrieved December 1,
2015 from http://www.nbcf.org.au/Research/About-Breast-Cancer.aspx
National Cancer Institute (2015). Fast Stats. Retrieved December 1, 2015 from
91
http://seer.cancer.gov/faststats/selections.php?series=data
Stasi, R., Abriani, L., Beccaglia, P., Terzoli, E. & Amadori, S. (2003). Cancer-Related Fatigue:
Evolving Concepts in Evaluation and Treatment. Cancer, 98 , 1786–1801.
Suzanne, C. D., Shannon, L. M., Gregory, B. R., Cassie, R. C., Lynn, F., Kristin, D. & Edward,
A.L. (2009). Restorative yoga for women with breast cancer: findings from a
randomized pilot study. Psychooncology, 18 (4), 360-368.
Taso, C.J., Lin, H.S., Lin, W.L., Chen, S.M., Huang, W.T. & Chen, S.W. (2014). The Effect of
Yoga Exercise on Improving Depression, Anxiety, and Fatigue in Women With Breast
Cancer: A Randomized Controlled Trial. The Journal of Nursing Research, 22 (3),
155-164.
Van Uden-Kraan, C.F., Chinapaw, M.J.M., Drossaert, C.H.C., Verdonck-de Leeuw, I.M. &
Buffart, L.M. (2013). Cancer patients’ experiences with and perceived outcomes of
yoga: results from focus groups. Support Care Cancer, 21 , 1861-1870.
Wang, G.F., Wang, S.H., Jiang, P.L. & Zeng, C. (2014). Effect of Yoga on cancer related
fatigue in breast cancer patients with chemotherapy. Journal of Central South
University (Medical Science), 39 (10), 1077-1082.