bmj open · for peer review only consort 2010 checklist page 2 assessing outcomes) and how 11b if...

For peer review only

A Quasi-Experimental, 4-week Interventional Study to Investigate the Effects of a Psycho-educational Support

Group Therapy on Cancer Caregivers’ Burden and Quality of Life – the COPE Study Protocol

Journal: BMJ Open

Manuscript ID: bmjopen-2015-008527

Article Type: Protocol

Date Submitted by the Author: 21-Apr-2015

Complete List of Authors: Mahendran, Rathi; National University Health System, Psychological Medicine; Duke-NUS Graduate Medical School, Tan, Joyce; National University of Singapore, Psychological Medicine Ng, Hui Ying; National University of Singapore, Psychological Medicine Lim, Haikel; National University of Singapore, Psychological Medicine Chua, Joanne; National University Hospital, Psychological Medicine Lim, Siew Eng; National University Cancer Institute, Singapore, National University Health System, Griva, Konstatina; National University of Singapore, Psychology Kua, Ee Heok; National University Health System, Psychological Medicine

<b>Primary Subject Heading</b>:

Mental health

Secondary Subject Heading: Research methods, Oncology, Health services research

Keywords: MENTAL HEALTH, ONCOLOGY, PSYCHIATRY

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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A Quasi-Experimental, 4-week Interventional Study to Investigate

the Effects of a Psycho-educational Support Group Therapy on

Cancer Caregivers’ Burden and Quality of Life – the COPE Study

Protocol

R Mahendran, JYS Tan, HY Ng, HA Lim, J Chua, SE Lim, K Griva, EH Kua

Rathi Mahendran, MBBS, MMed (Psychiatry), MMedEd, FAMS Senior Consultant1 and Associate Professor2,3

Joyce Yi Siang Tan, BSocSci (Hons)

Research Assistant2

Hui Ying Ng, BSocSci (Hons) Research Assistant2

Haikel Asyraf Lim, BSocSci (Hons)

Research Assistant2 Joanne Chua, BSc (Hons), MSc, MPsy (Clinical)

Senior Psychologist1 and Deputy Head, Psychology Unit1

Siew Eng Lim, MBBCh, BAO, ABIM (Int Med & Med Onc)

Senior Consultant4 and Clinical Director, Department of Haemotology-Oncology

4

Konstadina Griva, PhD

Associate Professor5 Ee Heok Kua, MBBS, MD, FRCPsych

Senior Consultant1 and Professor of Psychiatry2

1 Department of Psychological Medicine, National University Hospital

NUHS Tower Block, Level 9 1E Kent Ridge Road, Singapore 119228

2 Department of Psychological Medicine, National University of Singapore NUHS Tower Block, Level 9 1E Kent Ridge Road, Singapore 119228

3 Duke-NUS Graduate Medical School Singapore, 8 College Road, Singapore 169857

4 National University Cancer Institute, Singapore, National University Health System NUHS Tower Block, Level 7 1E Kent Ridge Road, Singapore 119228

5 Department of Psychology, National University of Singapore

Block AS4, #02-07 9 Arts Link Singapore 117570

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Corresponding author:

Dr. R Mahendran Department of Psychological Medicine, National University Health System NUHS Tower Block, Level 9 1E Kent Ridge Road, Singapore 119228 Email: [email protected] DID: +65 6772 3893 Fax: +65 6777 2191 Keywords: Neoplasms/psychology*, Stress, Psychological/therapy*,

Caregivers/psychology*, Psychosocial intervention, Mixed methods, Support group

Word count: 3827 words

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ABSTRACT

Background: Despite the rising trend of cancer prevalence and increase in family

caregiving, research on psychosocial support group services for family caregivers of

cancer patients is sparse, with a narrow range of conceptual frameworks and little

qualitative research conducted to explore the field. In particular, little attention has

been paid to the efficacy of support group interventions on Asian caregiver samples.

This trial aims to evaluate the effectiveness of a 4-week psychoeducational support

group on family caregivers in Singapore.

Methods and Analysis: Participants will be recruited at the waiting area of the clinic,

while they are accompanying their care recipients. Because no previous work has

been done in Singapore, sample size was not calculated. The intervention is

conducted by a trained psychologist at the National University Cancer Institute,

Singapore. A mixed methods approach is used. A battery of tests is administered at

four time-points before and after the intervention: baseline, post-intervention, and

follow-up at one- and two-months post-intervention. Outcomes assessed include

quality of life, anxiety, depression, stress, basic psychological needs, perceived

competence, interpersonal support, and healthcare climate. Semi-structured interviews

are conducted at baseline and post-intervention to examine caregivers’ support needs,

and learning outcomes from the intervention.

Ethics and Dissemination: This study protocol has received approval from the local

ethics committee, the National Healthcare Group Domain Specific Review Board

(NHG DSRB Ref: 2013/00662). Written informed consent is obtained from every

participant. Results from the study will be disseminated through journals and

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conferences, and will be particularly relevant for clinicians intending to implement

similar support groups to address the psychosocial concerns of caregivers, as well as

for researchers seeking to refine the structure and evaluate the effectiveness of such

programs.

Trial registration: Current Controlled Trials NCT02120183 (Version 1.0, dated 17

April 2015)

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INTRODUCTION

Background and rationale

Cancer is a major cause of morbidity and mortality with worldwide prevalence

estimated at 14.1 million new cases and 8 million cancer-related deaths in 2012 [1].

Each patient’s cancer journey is shared by their caregivers who may be as profoundly

affected by the diagnosis and outcomes. The American Cancer Society defines a

caregiver as a family member, friend, loved one or other support person who lends

physical, emotional or other support to someone at any time during the cancer journey

[2]. The National Cancer Institute defines the caregiver as “providing a complex array

of support tasks that extend across physical, psychological, spiritual and emotional

domains” [3]. Importantly, they are part of a triadic model of involvement together

with the patient and healthcare professional and take on multiple roles from

involvement in treatment decision-making in cancer, to acting as conduits of

information between patient and the specialist and vice versa and supporting the

patient’s decisions [4].

Functional expectations of caregivers are often huge with multiple

responsibilities such as administrative tasks, instrumental tasks, navigational tasks and

social support activities [5]. The literature reflects a high level of stress amongst

cancer caregivers ranging from physical symptoms of fatigue to emotional symptoms

of stress, anxiety and depression, and social effects such as restricted roles and

activities and strained marital relationships and reduced quality of life [6].

As cancer survivorship grows, from 50 % in the seventies, to 54% between

1983 and 1985 and 65% in 2009, the illness may become a chronic disease, further

stressing caregivers with a cumulative and unrelenting burden of care [7]. A cognitive

stress theory explains that the experience of the stress depends on the relationship

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between demands and resources as perceived by the caregiver [8]. The burden of

unrelenting care and cumulative issues and responsibilities caregivers assume

contribute to the whole impact of the caregiving process. The effects on the caregivers

may in turn negatively affect patient’s health and well-being [9] .

A descriptive cross-sectional survey of caregivers found that 43% of

caregivers had unmet needs and they were more likely to be in poor health [10]. The

situation is compounded when caregivers look after patients with “high grade disease”

such as brain tumors; there is a clear trend for lower quality of life amongst this group

of caregivers [11]. Schulz et al. found that caregivers had a higher level of psychiatric

symptomatology and illness as compared to population norms [12]. Up to 95% of

caregivers have reported severe sleep problems and fatigue and over half in one study

experienced symptoms of clinical depression [13]. Another study among 54

caregivers found that most experienced a diminished sense of emotional well-being.

Flaskerud et al. found that the distress may affect both the mental and physical health

[14].

Cancer patients and their caregivers have identified five points in the cancer

journey as being particularly important: “around diagnosis, during treatment, after

discharge, at recurrence and the final weeks” [15]. The early stages of caregiving are

marked by emotional stress as the family begins to cope with the diagnosis and the

changes to family relationships, lifestyle and even socio-economic circumstances for

some families [16]. At subsequent stages of the illness process, caregiver stress levels

are often proportional to the ups and downs of the patient’s illness [15]. Studies

indicate that early intervention for caregivers is most effective in preventing later

development of psychological distress in both the cancer patient and the caregiver

[17]. This is also applicable for recurrence fears, an issue caregivers report higher

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concerns about compared to patients [18]. Early fears and distress continue to trouble

caregivers further emphasizing that intervention is beneficial at an early stage.

Unfortunately there is a paucity of research on the quality of life or

interventions for cancer caregivers in Asian populations. A literature search of articles

on cancer caregivers from 1990 returned 107 articles after excluding pediatric,

hospice, and palliative populations. Out of these, only 12 were from Asian countries

(6 Taiwan, 5 Korea, and 1 Japan). In Singapore, available services in Cancer Centers

focus primarily in providing support for patients although both patients and caregivers

do receive education and information about the cancer, treatment and side-effects,

knowledge and practical approaches to appearance and adjusting to lifestyle changes.

Where family counseling is provided, it is mainly for loss, grief and bereavement

issues and at a late stage of the illness, more towards the palliative care end of the

spectrum. Caregivers participate in such groups mainly in a supportive role to the

patient. However, the literature suggests cancer caregivers have unique psychological,

emotional, and lifestyle needs, that patient support groups may not be able to

adequately meet.

Addressing caregiver needs enables and builds their resilience in meeting the

needs of the patient and also enhances the triadic relationship between patient,

healthcare professional and caregiver. This will go a long way towards improving

communications and understanding in care related matters and benefits the healthcare

team as well.

Objectives

The current study therefore aims to:

1) Implement a psychosocial group intervention that provides psycho-

educational information and support to family caregivers of patients with cancer.

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2) Assess the efficacy of the intervention on primary outcomes of caregiver

quality of life, anxiety, stress, and depression, and basic psychological needs at

baseline and follow-up immediately post-intervention, and one and two-months post-

intervention.

Following the SPIRIT guidelines [19], this paper describes the procedural

details of the study design and intervention.

Trial design

This quasi-experimental interventional study aims to evaluate the

effectiveness of a 4-week psycho-educational support group therapy. The study

protocol had ethics approval from the National Healthcare Group (NHG) Domain

Specific Review Board (DSRB) (Ref. No. 2013/00662). Two groups of participants

will be assessed; participants are self-selected into either group based on their

availability to attend the support group.

Group 1: Family caregivers attending the support group.

Group 2: Family caregivers interested in, but unavailable to attend the support group.

METHOD

Study setting and center recruitment

Subjects will be recruited from the Medical Oncology Clinic at the National

University Cancer Institute, Singapore (NCIS).

Eligibility criteria

The inclusion criteria are:

1) 21 to 74 years of age,

2) willingness to attend a 1-hour program every week for 4 weeks,

3) ability to understand and speak basic English, ability to understand and

complete self-report questionnaires with minimal assistance,

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4) status as primary adult family member who provides care and support for

the patient and lives together with the patient.

The exclusion criteria are:

1) age younger than 21 years of age, or older than 75 years,

2) inability to understand and speak basic English, and inability to understand

and complete self-report questionnaires with minimal assistance.

Participants can request to withdraw from the study at any time without

having to give any reason.

Intervention

The planned intervention was developed by the team in discussions and

consensus views. It adapted the Brief Integrative Psychological Therapy (BIPT)

developed at the National University of Singapore [20], and psycho-educational

programs from overseas centers. BIPT is an eclectic approach to psychotherapy that

integrates different approaches, and was developed in response to local needs. It uses

cognitive-behavioral, psychodynamic and supportive approaches, and where relevant

to the patient’s needs, meditation and relaxation therapy. BIPT was used to provide a

locally-specific intervention. This was moreover supported by the team’s previous

study on local caregivers’ QOL, using the Caregiver Quality of Life Scale for Cancer

(CQOLC) [21]. This study suggested that the factor structure for local caregiver

populations differed slightly from the original four-factor model or Taiwanese five-

factor model: instead of spiritual wellbeing and financial concerns, physical/practical

concerns, emotional reactivity and self-needs emerged as new factors [22].

In addition, our experience with previous Mindfulness-based Cognitive

Therapy groups showed a high dropout rate with a longer number of group sessions;

participants preferred shorter interventions. We thus designed an intervention that

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could be covered in four hour-long sessions. The intervention consists of weekly

Psycho-educational Support Groups focusing on topics specific to psychosocial and

emotional aspects of the cancer caregiving role. The proposed intervention is

exploratory in nature but is hypothesized to be beneficial in helping to recognize and

handle the difficult and often tumultuous journey of cancer caregiving

The intervention utilizes an expert-led cum peer-support framework. It aims to

increase self-knowledge and emotional self-regulation through the group experience

and to help caregivers modulate emotional reactivity to unpredictable events

associated with the course of the cancer illness. The support group used a structured

framework; each session had different content as listed below.

Week 1: focused on the emotions surrounding the shock of a diagnosis.

Week 2: introduced self-care and muscle relaxation techniques.

Week 3: introduced positive thinking skills through basic cognitive-behavioral

therapy techniques, and

Week 4: looked at the emotional reactivity that arises in the patient, caregiver

and family.

The more intense, sensitive topics are kept till later, so that caregivers can

become more familiar with the format of the group, and with one another.

Delivery of intervention. The intervention will be run by a trained clinical

psychologist who will advise and handle the participants’ needs in each session and

help them deal with the emotions related to their roles. The programme will be

formalized in a series of materials handed out to participants in each session of the

intervention, catering to each specific session’s topic.

Outcomes

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The following primary outcomes were measured: Quality of life (QOL), stress

levels, depressive and anxiety symptoms. Self-report questionnaires were used at

baseline (Time 1), after the 4 week intervention (Time 2), and at 4 weeks (Time 3)

and 8 weeks (Time 4) post-intervention. Additional measures of healthcare climate,

interpersonal support and perceived competence were used immediately post-

intervention at Time 2.

QOL. This was measured using the Caregiver Quality of Life-Cancer Scale

[21], designed to measure the QOL of family caregivers of patients with cancer. It

comprises 35-items and yields a single QOL score. Although some studies have

worked with four subscales (financial concerns, disruptiveness, burden, positive

adaptation), a recent validation study done in Singapore suggested the existence of a

different factor structure amongst the local caregiver population [22]. The items are

scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores

range from 0 to a maximum of 140. Higher scores indicate better QOL and the scale

has good psychometric properties [21].

Stress. The Perceived Stress Scale is originally a 14-item scale [23] developed

as a global measure of stress. To reduce participants’ response burden, we used the

PSS-10, a 10-item short version with high reliability and validity [24]. It requires

participants to indicate how often they have experienced each of the statements in the

last month on a five-point scale from 0 (never) to 4 (very often). Scores are obtained

by reversing responses to the positively stated items and then summing across all

scale items. It has been used to assess stress amongst Singaporean adults and has good

reliability coefficients [25].

Anxiety and depressive symptoms. The Hospital Anxiety Depression Scale

(HADS) [26] is a widely used self-rated 14-item questionnaire. It asks participants to

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indicate which of four options from 0 to 3 – with 3 indicating higher symptom

frequency – best describes their feelings over the past week. Anxiety and depressive

symptoms are scored on separate subscales of 7 items each. Scores range to a

maximum of 21 for each subscale and good psychometric properties are frequently

reported [27].

Basic psychological needs. The Basic Psychological Needs in General Scale

(BPNS) contains 21 items that measure the degree to which people experience the

basic psychological needs in their lives. It is divided into subscales measuring a need

for autonomy (7 items), competence (6 items) and relatedness (8 items) with each

item measured on a seven-point scale from 1 (not at all) to 7 (very true). A previous

study using the original scale found acceptable to excellent psychometric properties

[28] for the full scale (α = .89), and its subscales of autonomy (α = .69), competence

(α = .71) and relatedness (α = .86).

A shortened version is used in this study to reduce burden of completion and

reduce fatigue amongst participants completing the study questionnaire. Previous

studies have employed various brief versions containing either 9 or 15 items, with

good psychometric properties. Fifteen-item versions of the scale demonstrate

acceptable reliability (α = .79 to .87) [29, 30] and studies have worked with only 9

items, namely, 3 items per subscale [31–33]. This study used a modified version of

the 9-item short scale [31–33]. One item (“I get along with people I come into contact

with.”) was replaced with another item from the original scale (“I really like the

people I interact with”) based on recommendations that wording in scale items be as

specific, concrete and non-ambiguous as possible [34]. The 9-item questionnaire has

three subscales with three items each: autonomy, competency, and relatedness.

Participants were asked, based on their role as a caregiver in the past month, the

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degree to which they agree with the statements on a 7-point Likert-type scale from 1

(not at all) to 7 (very true).

Healthcare environment. The Healthcare Climate Questionnaire (HCCQ) [35]

is from a family of scales that assess the degree to which a social context is autonomy

supportive for target individuals. Participants are asked to indicate how true each

statement was for them during their participation in the support group therapy. This

scale has been used for both specific interpersonal styles of healthcare providers, as

well as the interpersonal climate of a clinic or group of providers. Responses are

recorded on a 7-point Likert scale from 1 to 7 (strongly disagree to strongly agree).

The HCCQ is specific to healthcare contexts and was created with a sample of 276

patients, with high reliability (α = .95) [35]. The 5-item scale used in this study is a

shortened version of the original 15-item scale and has been found to have a

Cronbach alpha of 0.80, correlating 0.91 with the full scale, thus indicating that the

modified scale is a fully adequate version of the longer HCCQ [36]. It has been used

on samples of diabetic patients, where patient perception of autonomy support from a

health care provider related to a change in HbA1c values at 12 month [36].

Interpersonal Support Evaluation List (ISEL). The ISEL [37] was designed to

measure perceptions of social support among individuals in the general population.

The original ISEL was designed to measure four functions of perceived support:

tangible (i.e., material assistance or instrumental support), belonging (i.e.,

identification with one's social network), self-esteem (i.e., from positive comparisons

with others), and appraisal support (i.e., informational support). The ISEL was

subsequently modified by its creators with the removal of the self-esteem subscale

and elimination of items to form a 12-item short version. The 4-item appraisal support

subscale of this modified scale is used here to assess the perceived availability of

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someone to talk to about one’s problems. Participants are asked, in the past two

weeks, the degree to which they agree with the statements on a 5-point Likert-type

scale from 1 (definitely false) to 3 (definitely true). The ISEL was initially developed

and validated using a community sample [29] and the 12-item short form was further

validated in samples with risks of respiratory illness, osteoarthritis interventions, risks

of subclinical CVD and breast cancer interventions. The appraisal support subscale

shows acceptable reliability of α = .67—.77 [38, 39]. The ISEL in its original 40-item

form has been used in investigations of the effects of an intervention on breast cancer

patients [40], and a shorter 6-item form of the 12-item scale has been used in quality

of life amongst older adults [39], and amongst cancer caregivers [41], amongst others.

Perceived Competence. The Perceived Competence Scale (PCS) is a short, 4-

item questionnaire typically written to be specific to the relevant behavior or domain

being studied. The PCS assesses participants’ feelings of competence in specific

domains or contexts. Participants are asked to indicate how true each statement has

been for them in the past 2 weeks. Responses are recorded on a 7-point Likert scale

from 1 to 7 (strongly disagree to strongly agree). The scale has had excellent internal

consistency (α = 0.80 to 0.94) [36, 42]. It has been linked to physiological outcomes

in diabetic patients, where increases in a patient's perceived competence related to

significant reductions in their HbA1c values over 12 months [36].

Participant timeline

The quasi-experimental framework was used to accommodate caregivers’

schedules. Caregivers were recruited into the intervention based on their availability

and interest. Interested caregivers could enter each of two conditions: the intervention

group or the control group, which was waitlisted. Available caregivers are placed in

the first group (Group 1a) till a group size of ten is reached. The next ten will be put

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on a wait-list and form the control group (Group 1b), who will still be able to benefit

from the program at a later time. In this manner subsequent treatment and control

groups will be recruited.

Participants’ written informed consent is taken and the baseline questionnaire

administered before the start of the first support group session (Time 1). At the final

session, after 4 weeks, participants complete a second questionnaire (Time 2) and are

handed a packet of two follow-up questionnaires (Time 3 and Time 4) with stamped

envelopes addressed to the Principal Investigator. These are to be returned after

completion at the one- and two-month follow-up assessment points.

The RA meets participants on the wait-list control group separately to get the

informed consent and complete the first questionnaire.

An inconvenience fee of $15 is paid to each participant after completion of

each support group session. Participants in the waitlist control arm are paid $15 upon

receipt of their completed questionnaire.

Missed sessions. To accommodate caregivers’ schedules, participants who

were unable to make it for one or more sessions were permitted to complete the

session they had missed in a following month; that is, if a participant missed Session

2 of the intervention, they could complete the other sessions first before completing

Session 2 in a following month.

Sample size calculation

Prior information on the outcomes of support group interventions for

caregivers is lacking in Singapore. As such, it is not possible to compute a sample size

for the study. This study thereby functions as a pilot study for future work on local

family caregivers.

Recruitment

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Research assistants (RAs) will approach family members accompanying

patients at the waiting areas of the clinic and provide them with a flyer and introduce

the study in brief. If interested, family members are provided with a Participant

Information Sheet that provides more details of the study. Those who are keen to

participate will be asked to leave their contact details (phone number) with the RA

who will subsequently confirm availability and register the caregiver in the next

available support group session.

Data management

Each participant will be assigned a unique subject identification number so

that they can be tracked anonymously throughout. The trial data will be entered into

an SPSS database by the RAs.

Statistical considerations

Outcomes will be analysed immediately after the intervention and at 1 and 2

months after the intervention ends. Participants will be assessed on an intention-to-

treat basis. To examine changes within groups (intervention vs. control) on baseline

and follow-up assessments, Analyses of Covariance (ANCOVAs) will be performed

for each outcome measure. Demographic and casemix differences between the groups

will be used as covariates.

In addition, a “per protocol” analysis will be conducted to examine caregivers

who were able to complete all four sessions of the intervention arm.

No formal subgroup analyses are planned but exploratory analyses of the

caregiver demographics (e.g. age range, ethnicity, income level) on the effect of the

intervention will be carried out.

DISCUSSION

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Although support group interventions have had a significant positive impact

on multiple outcomes [43], there is a paucity of research on caregiver populations in

Asia. The majority of studies have been mainly conducted on female, Caucasian

caregiver populations [44]. Studies of the Asian caregiving experience are few and far

between [45–47] . Moreover, research on caregivers in Singapore is concentrated on

dementia and elderly care recipients [48, 49]. However, with rising prevalence of non-

communicable chronic diseases such as cancer and depression [50, 51], there is a

greater need for research on how caregivers in Asia are impacted and cope. The

common finding that depression prevalence is higher amongst Asian caregiver

populations than Western caregiver populations suggests the possibility that Asian

populations may experience a greater burden of caregiving.

Group-based approaches may provide cost-effective means of providing

mental healthcare. However, few studies have examined the impact of support groups

on family caregivers. Only two of 29 RCTs reviewed in a meta-analysis conducted

caregiver-only groups [43]. Group-based interventions are of interest because they are

more cost-effective than one-on-one counselling in providing structured support.

Moreover, feedback has been generally positive. Caregiver-focused groups were rated

as providing skills such as information and support that reduced the negative appraisal

of caregiving, decreased uncertainty, and lessened hopelessness, while also teaching

skills to cope with the stresses of caregiving [52]. This supports suggestions that such

groups might give caregivers the chance to openly interact with other caregivers in the

absence of their care recipients [43]. Moreover, in a systematic review of

psychosocial interventions, group-based or otherwise, caregivers listed the most

useful aspect of interventions as regular interactions with a professional, providing the

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chance to openly communicate issues with them and as a time to talk about feelings

and questions related to cancer [52, 53].

There is also a need to expand qualitative understandings of how a support

group is received in cultural contexts which are not attuned to support groups, much

less one for cancer. In Singapore, cancer is still seen as a terminal disease with little

hope of recovery, and there is also a stigma against psychological counselling and

psychiatric support, facilitated by the general stigma against mental illness amongst

both patients and paradoxically, healthcare professionals [54]. Furthermore, a family–

centred model of decision-making tends to be predominant in Asian populations [55],

and in Singapore, this is further encouraged by public policy such as healthcare

subsidies that are based on a calculation of the immediate family’s total income,

rather than individual income [56]. Beliefs or expectations of the role the family

caregiver ought to play may thus exist and may influence the way individuals respond

to the intervention.

With the rising trend of cancer and other non-communicable diseases, the

global disease burden will be increasingly shouldered by chronic, outpatient care.

Much of this will involve the immediate family and bring with it costs to caregiver

well-being. Effective short-term interventions are needed to provide support to

caregivers managing busy schedules.

However, the current trial does pose methodological challenges in recruiting

and ensuring attendance for all consecutive sessions of the support group. To

accommodate caregivers’ needs, caregivers will make up for sessions they miss in

follow-up sessions. These will be taken into account in data analysis.

Ethics and dissemination

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Informed consent will be obtained from all participants and confidentiality of

the issues raised during the support group will be maintained strictly. All data will be

anonymised and maintained in accordance with the guidelines stated by the NHG

DSRB.

Dissemination of findings will include presentations at conferences and

publications in peer review journals.

Competing interests

The authors declare that they have no competing interests.

Funding

The National University Cancer Institute, Singapore Centre Grant FY2013-2016,

Seed Funding Program supported the study.

Authors’ contributions

HYN and JT coordinated the support groups, administered the questionnaires, and

helped draft the manuscript. HYN conducted the interviews and will be performing

the statistical analyses. JC conducted the support groups. HL participated in the

design of the study and statistical analysis. KG advised on study methodology and

statistical analysis. RM and EHK conceptualized the study, and participated in its

design and coordination and helped draft the manuscript. SEL was involved in study

design and facilitating the conduct of the study at the National University Cancer

Institute, Singapore. All authors read and approved the final manuscript.

Authors’ information

The study was initiated by results from a previous study by JC, which found

significant levels of stress and a demand for psychological support services amongst

family cancer caregivers at the National University Cancer Institute, Singapore, under

the National University Health System.

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SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and

related documents*

Section/item ItemNo

Description

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions,

and, if applicable, trial acronym (completed)

Trial registration 2a Trial identifier and registry name. If not yet registered, name of

intended registry (completed)

2b All items from the World Health Organization Trial Registration Data

Set (NA)

Protocol version 3 Date and version identifier (completed)

Funding 4 Sources and types of financial, material, and other support

(completed)

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors (completed)

5b Name and contact information for the trial sponsor (NA)

5c Role of study sponsor and funders, if any, in study design; collection,

management, analysis, and interpretation of data; writing of the report;

and the decision to submit the report for publication, including whether

they will have ultimate authority over any of these activities (NA)

5d Composition, roles, and responsibilities of the coordinating centre,

steering committee, endpoint adjudication committee, data

management team, and other individuals or groups overseeing the

trial, if applicable (see Item 21a for data monitoring committee) (NA)

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the

trial, including summary of relevant studies (published and

unpublished) examining benefits and harms for each intervention

(completed)

6b Explanation for choice of comparators (completed)

Objectives 7 Specific objectives or hypotheses (completed)

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Trial design 8 Description of trial design including type of trial (eg, parallel group,

crossover, factorial, single group), allocation ratio, and framework (eg,

superiority, equivalence, noninferiority, exploratory) (completed)

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital)

and list of countries where data will be collected. Reference to where

list of study sites can be obtained (completed)

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility

criteria for study centres and individuals who will perform the

interventions (eg, surgeons, psychotherapists) (completed)

Interventions 11a Interventions for each group with sufficient detail to allow replication,

including how and when they will be administered (completed)

11b Criteria for discontinuing or modifying allocated interventions for a

given trial participant (eg, drug dose change in response to harms,

participant request, or improving/worsening disease) (NA)

11c Strategies to improve adherence to intervention protocols, and any

procedures for monitoring adherence (eg, drug tablet return,

laboratory tests) (NA)

11d Relevant concomitant care and interventions that are permitted or

prohibited during the trial (NA)

Outcomes 12 Primary, secondary, and other outcomes, including the specific

measurement variable (eg, systolic blood pressure), analysis metric

(eg, change from baseline, final value, time to event), method of

aggregation (eg, median, proportion), and time point for each

outcome. Explanation of the clinical relevance of chosen efficacy and

harm outcomes is strongly recommended (completed)

Participant

timeline

13 Time schedule of enrolment, interventions (including any run-ins and

washouts), assessments, and visits for participants. A schematic

diagram is highly recommended (see Figure) (completed)

Sample size 14 Estimated number of participants needed to achieve study objectives

and how it was determined, including clinical and statistical

assumptions supporting any sample size calculations (completed)

Recruitment 15 Strategies for achieving adequate participant enrolment to reach

target sample size (NA)

Methods: Assignment of interventions (for controlled trials)

Allocation:

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Sequence

generation

16a Method of generating the allocation sequence (eg, computer-

generated random numbers), and list of any factors for stratification.

To reduce predictability of a random sequence, details of any planned

restriction (eg, blocking) should be provided in a separate document

that is unavailable to those who enrol participants or assign

interventions (NA)

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central

telephone; sequentially numbered, opaque, sealed envelopes),

describing any steps to conceal the sequence until interventions are

assigned (NA)

Implementation 16c Who will generate the allocation sequence, who will enrol participants,

and who will assign participants to interventions (NA)

Blinding

(masking)

17a Who will be blinded after assignment to interventions (eg, trial

participants, care providers, outcome assessors, data analysts), and

how (NA)

17b If blinded, circumstances under which unblinding is permissible, and

procedure for revealing a participant’s allocated intervention during

the trial (NA)

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other

trial data, including any related processes to promote data quality (eg,

duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with

their reliability and validity, if known. Reference to where data

collection forms can be found, if not in the protocol (completed)

18b Plans to promote participant retention and complete follow-up,

including list of any outcome data to be collected for participants who

discontinue or deviate from intervention protocols (NA)

Data

management

19 Plans for data entry, coding, security, and storage, including any

related processes to promote data quality (eg, double data entry;

range checks for data values). Reference to where details of data

management procedures can be found, if not in the protocol

(completed)

Statistical

methods

20a Statistical methods for analysing primary and secondary outcomes.

Reference to where other details of the statistical analysis plan can be

found, if not in the protocol (completed)

20b Methods for any additional analyses (eg, subgroup and adjusted

analyses) (NA)

20c Definition of analysis population relating to protocol non-adherence

(eg, as randomised analysis), and any statistical methods to handle

missing data (eg, multiple imputation) (NA)

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Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role

and reporting structure; statement of whether it is independent from

the sponsor and competing interests; and reference to where further

details about its charter can be found, if not in the protocol.

Alternatively, an explanation of why a DMC is not needed (NA)

21b Description of any interim analyses and stopping guidelines, including

who will have access to these interim results and make the final

decision to terminate the trial (NA)

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and

spontaneously reported adverse events and other unintended effects

of trial interventions or trial conduct (NA)

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and

whether the process will be independent from investigators and the

sponsor (NA)


Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board

(REC/IRB) approval (NA)

Protocol

amendments

25 Plans for communicating important protocol modifications (eg,

changes to eligibility criteria, outcomes, analyses) to relevant parties

(eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators) (NA)

Consent or assent 26a Who will obtain informed consent or assent from potential trial

participants or authorised surrogates, and how (see Item 32) (NA)

26b Additional consent provisions for collection and use of participant data

and biological specimens in ancillary studies, if applicable (NA)

Confidentiality 27 How personal information about potential and enrolled participants will

be collected, shared, and maintained in order to protect confidentiality

before, during, and after the trial (completed)

Declaration of

interests

28 Financial and other competing interests for principal investigators for

the overall trial and each study site (completed)

Access to data 29 Statement of who will have access to the final trial dataset, and

disclosure of contractual agreements that limit such access for

investigators (NA)

Ancillary and

post-trial care

30 Provisions, if any, for ancillary and post-trial care, and for

compensation to those who suffer harm from trial participation (NA)

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Dissemination

policy

31a Plans for investigators and sponsor to communicate trial results to

participants, healthcare professionals, the public, and other relevant

groups (eg, via publication, reporting in results databases, or other

data sharing arrangements), including any publication restrictions

(NA)

31b Authorship eligibility guidelines and any intended use of professional

writers (NA)

31c Plans, if any, for granting public access to the full protocol, participant-

level dataset, and statistical code (NA)

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to

participants and authorised surrogates (NA)

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological

specimens for genetic or molecular analysis in the current trial and for

future use in ancillary studies, if applicable (NA)

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013

Explanation & Elaboration for important clarification on the items. Amendments to the

protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT

Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported”

license.

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A Pilot, Quasi-Experimental, Mixed Methods Investigation into the Efficacy of a Psycho-educational Support Group

Intervention for Caregivers of Cancer Outpatients – The COPE Study Protocol

Journal: BMJ Open

Manuscript ID: bmjopen-2015-008527.R1


Date Submitted by the Author: 23-Jul-2015

Complete List of Authors: Mahendran, Rathi; National University Health System, Psychological Medicine; Duke-NUS Graduate Medical School, Tan, Joyce; National University of Singapore, Psychological Medicine Griva, Konstadina; National University of Singapore, Psychology Lim, Haikel; National University of Singapore, Psychological Medicine Ng, Hui Ying; National University Hospital, Psychological Medicine Chua, Joanne; National University Hospital, Psychological Medicine Lim, Siew Eng; National University Cancer Institute, Singapore, National University Health System, Kua, Ee Heok; National University Health System, Psychological Medicine


Mental health

Secondary Subject Heading: Research methods, Oncology, Health services research, Evidence based practice

Keywords: MENTAL HEALTH, ONCOLOGY, PSYCHIATRY, QUALITATIVE RESEARCH


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A Pilot, Quasi-Experimental, Mixed Methods Investigation into the Efficacy

of a Psycho-educational Support Group Intervention for Caregivers of Cancer

Outpatients – The COPE Study Protocol

R Mahendran, JYS Tan, K Griva, HA Lim, HY Ng, J Chua, SE Lim, EH Kua



Research Assistant2

Konstadina Griva, PhD Associate Professor4

Haikel Asyraf Lim, BSocSci (Hons) Research Assistant2

Hui Ying Ng, BSocSci (Hons)

Research Assistant1

Joanne Chua, BSc (Hons), MSc, MPsy (Clinical)



Senior Consultant4 and Clinical Director, Department of Haemotology-Oncology5 Ee Heok Kua, MBBS, MD, FRCPsych





3 Duke-NUS Graduate Medical School Singapore, 8 College Road, Singapore 169857 4 Department of Psychology, National University of Singapore Block AS4, #02-07 9 Arts Link Singapore 117570 5 National University Cancer Institute, Singapore, National University Health System


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Dr. R Mahendran Department of Psychological Medicine, National University Health System NUHS Tower Block, Level 9 1E Kent Ridge Road, Singapore 119228 Email: [email protected] DID: +65 6772 3893 Fax: +65 6777 2191 Keywords: Neoplasms/psychology*, Stress, Psychological/therapy*, Caregivers/psychology*,

Psychosocial intervention, Mixed methods, Support group

Word count: 4235 words

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ABSTRACT

Introduction: Despite the rising trend of cancer prevalence and increase in family caregiving,

little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver

samples, particularly support groups, given the benefits that have been shown in studies on

Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week

psychoeducational support group for Singaporean family caregivers of patients receiving

outpatient care.

Methods and Analysis: Facilitated by a clinical psychologist, this intervention is primarily

based on the Brief Integrative Psychological Therapy, with a supportive-expressive intent.

Participants will be recruited while they are accompanying their care recipients for outpatient

consultations. Because this is a pilot study, a sample size of 120 participants is targeted based on

sample sizes of previous studies. The study adopts a quasi-experimental design, as participants

are assigned the intervention or control arms based on their availability to attend the intervention.

A mixed methods approach is used to evaluate the outcomes of the intervention. A self-

administered battery of tests is completed at four time-points: baseline, post-intervention, and

follow-up at one- and two-months post-intervention; semi-structured interviews are conducted at

baseline and post-intervention. Primary outcomes are quality of life, anxious and depressive

symptoms; secondary outcomes are stress and basic psychological needs. Analysis using

ANCOVA would be conducted to determine the effectiveness of the intervention.

Ethics and Dissemination: This study protocol has ethics approval from the National

Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written

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informed consent is obtained from every participant. Results will be disseminated through

journals and conferences, and will be particularly relevant for clinicians intending to implement

similar support groups to address the psychosocial concerns of caregivers, as well as for

researchers seeking to refine the structure and evaluate the effectiveness of such programs.

Trial registration: Current Controlled Trials NCT02120183

(https://clinicaltrials.gov/show/NCT02120183)

Strengths of the study:

• The intervention here catering to caregivers of ambulatory cancer patients expands the limited work done among Asian caregivers on support group interventions.

• 4-week psycho-social intervention builds on previous programs and approaches developed for local caregivers, and hence directly addresses their concerns.

• The complementary strengths of the quantitative and qualitative data collection methods employed here provides a comprehensive understanding of the daily caregiving experience and the effectiveness of the support group.

Limitations of the study:

• Self-selection bias into study conditions may influence the evaluative outcomes, understating the actual effectiveness of the intervention.

• Restriction to English-speaking participants for the intervention may limit the generalizability of the findings.

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INTRODUCTION


Cancer is a major cause of morbidity and mortality with worldwide prevalence estimated

at 14.1 million new cases and 8 million cancer-related deaths in 2012 [1]. Each patient’s cancer

journey is shared by their caregivers who may be as profoundly affected by the diagnosis and

outcomes. The American Cancer Society defines a caregiver as a family member, friend, loved

one or other support person who lends physical, emotional or other support to someone at any

time during the cancer journey [2]. Importantly, they are part of a triadic model of involvement

together with the patient and healthcare professional and take on multiple roles, from

involvement in treatment decision-making in cancer, to acting as conduits of information

between patient and the specialist and vice versa and supporting the patient’s decisions [3].

Functional expectations of caregivers are often huge with multiple responsibilities such

as household chores, emotional support, providing transportation, and symptom management [4].

As cancer survivorship grows, from 50% in the seventies, to 54% between 1983 and 1985 and

65% in 2009, the illness may become a chronic disease, further stressing caregivers with a

cumulative and unrelenting burden of care and responsibility [5]. Psychological morbidity or

psychiatric symptomatology among cancer caregivers is high [6, 7]. Levels of distress has also

been shown to be higher than those reported by patients themselves [8].

As identified in stress process models (see example Pearlin et al., 1990 [9]), personal

resources moderate the psychosocial impact or strain related to caregiving. Key among those are

the more malleable psychological resources such coping strategies and social support, which

have consistently been shown to be associated with better caregiving outcomes [6, 10–12] and

thereby form core parts in interventions for cancer caregivers (see review by Waldron et al.,

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2013 [13]). This line of work indicates that the most efficacious interventions comprised of

skills-training and supportive-educational components such as psychosocial coping skills, family

involvement, and symptom management [13]. While there is a good evidence base for caregiving

interventions, most of the work has been conducted in Western settings [13, 14].

Group therapy for caregivers of cancer patients in Western studies have been shown to be

beneficial, due to group processes of social comparison, information sharing, and peer support

[15]. In Asia, the effectiveness of group therapy for caregivers of cancer patients is unclear, as

research work in this area has largely been absent. Cultural features specific to Asian cultures

may influence caregiver outcomes differently, in comparison to Western populations. For

example, Chinese caregivers displayed a tendency for collective decision making regarding

important decisions, adopted a fatalistic explanation for the care recipients’ illness, experienced a

sense of guilt and shame [16, 17], and had reservations in expressing their feelings to avoid

placing unnecessary burden on other family members [16, 18]. Familial obligation to care for the

family member with cancer was also emphasized [19]. Distress was often experienced in terms

physical symptoms, and emotional coping involved the strategy of endurance [17]. Because these

culturally-derived attitudes and perceptions frame the caregiving experience, interventions that

are culturally-sensitive, patient-centered, and theoretically-motivated have been advocated [20].

Existing interventions among Asian populations focus mainly on imparting practical

skills to caregivers of cancer patients requiring palliative care, through home-based care or home

visits from nurses [21–23], with an emphasis on coping with end-of-life issues and bereavement

[24, 25]. On the other hand, interventions for caregivers of non-palliative care recipients tend to

be delivered via the phone [26] or over the internet [27], while others work with couple dyads,

where one spouse provides care for the other who has cancer [28].

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Among Asian caregivers of other patient populations, studies have provided evidence of

its effectiveness and suitability [29, 30]. For example, comparing different types of psychosocial

interventions for caregivers of schizophrenia patients in Hong Kong, results from a randomized

controlled trial showed that caregivers in the mutual support group had greater improvements in

family and patient functioning than caregivers in the psycho-education and standard care groups,

with benefits being sustained over the long term [31]. While Asian families are known to be

reluctant to seek external help beyond the family unit [17], including professional help, they

appear willing to share their experiences with peers who are facing similar difficulties, making

support groups a more attractive option of seeking help [32].

To our best knowledge, the only one cancer caregiving intervention in Singapore has

recruited exclusively caregivers of advanced cancer patients with majority of the care recipients

being on home hospice care [33], hence generalizability to caregivers of ambulatory patients is

not clear. Outcomes such as quality of life (QOL) and burden have been shown to be better for

caregiving in context of home palliative care relative to those in ambulatory outpatient care [34].

Hence, the present study seeks to expand on this work by developing and evaluating the effect of

an intervention program for Asian cancer caregivers in ambulatory settings. The key

consideration was to adopt a culturally sensitive and pragmatic intervention approach that would

facilitate participation and retention among this group. As such, recommendations for

interventions that integrate various therapies and are time-efficient [35, 36] were deemed

paramount. Developed in response to these considerations, the protocol of this current

intervention – Caregiver of cancer Outpatients Psycho-Education support group therapy, or

known as COPE – is described here.

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Covered in 4 one-hour long weekly sessions, the intervention encompasses topics on the

psychosocial and emotional aspects of the caregiving role. Through facilitation by the clinical

psychologist and group interactions, it sought to increase self-knowledge, emotional regulation,

and coping strategies.

Aims of study

Using both quantitative and qualitative data collection methods, this study aims to

evaluate the efficacy of the intervention. Clinical indicators of quality of life (QOL), depressive

and anxious symptoms form the primary outcomes, while secondary outcomes comprise of stress

and basic psychological needs. Interviews are conducted also to qualitatively elicit responses

surrounding the challenges and needs caregivers face, their caregiving motivations, and feedback

on the intervention.

We hypothesize that there would be improvements in QOL, and decreases in depressive

and anxious symptoms after the intervention. Stress levels will be lower, with gains in

caregivers’ sense of autonomy, competence and relatedness.

METHOD

Trial design

This quasi-experimental study protocol has ethics approval from the National Healthcare

Group (NHG) Domain Specific Review Board (DSRB) (Ref. No. 2013/00662). Evaluation of the

intervention will be done by comparing two groups of participants:


Group 2: Family caregivers interested in, but are unavailable to attend the support group

at the moment, and will be waitlist to attend subsequent support groups.

Two arms of the study will be formed – the intervention arm and the control arm.

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3) ability to understand and speak basic English, ability to understand and complete

self-report questionnaires with minimal assistance,

4) status as primary adult family member who provides care and support for the patient

and lives together with the patient.



2) inability to understand and speak basic English, and inability to understand and

complete self-report questionnaires with minimal assistance.

Because this is a pilot study, and we hope to include as many caregivers as possible, no

exclusion was made based on care recipients’ cancer type, cancer stage, time since first

diagnosis, or current treatment of patients. Participants can request to withdraw from the study at

any time without having to give any reason.

Delivery of intervention. The intervention will be run by a clinical psychologist who will

provide psycho-education and facilitate the discussion among caregivers. The program will be

formalized in a series of materials handed out to participants in each session of the intervention,

summarizing each specific session’s topic.

Participants who become intensely distressed will have a personal consultation with the

clinical psychologist.

COPE Intervention

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This intervention is part of ongoing quality improvement efforts to implement Psycho-

oncology services at the National University Cancer Institute, Singapore (NCIS) [37], which

includes a needs assessment survey using the Caregiver Quality of Life – Cancer instrument

[38], and modified 5-week Mindfulness-Based Cognitive Therapy (MBCT) groups conducted

previously [37]. Results from the survey and feedback from MBCT groups participants indicated

a unique set of needs of Singaporean caregivers. While endorsing needs of emotional and social

support, and physical/practical concerns, constraints in time commitment resulted in preferences

for shorter interventions, as well as interventions that encompass additional therapeutic

components beyond mindfulness, such as supportive talk therapy and psycho-education. These

needs and preferences of local caregivers were taken into consideration when the expert team –

made up of psychiatrists and a psychologist – collaborated to develop this intervention.

Accommodating local preferences for a multi-faceted therapeutic program, the Brief

Integrative Psychological Therapy (BIPT) – developed at the National University of Singapore

[36, 39] – was the primary therapeutic approach guiding the intervention. Originally developed

in response to local needs for time efficient therapy that combines various psychotherapy

techniques [39], the BIPT’s eclectic approach integrates cognitive-behavioral, psychodynamic

and supportive approaches, as well as meditation and relaxation therapy. In addition, the patient-

centric focus emphasizes customized therapeutic approaches to target patients’ specific needs

[36]. In designing this current intervention, we infused elements of cognitive behavioral therapy

and supportive therapy.

Recognizing the psychological changes accompanying the caregiving role [10], the self-

determination theory (SDT) [40] motivated the secondary focus of the intervention. The theory

proposes that when social environments are supportive of individuals’ basic psychological needs

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for autonomy, competence and relatedness, greater psychological well-being is attained. This

gives an intrinsic motivation for behaviors driven by these psychological needs [40]. Hence,

support group sessions are designed towards creating a platform that promotes participants’

sense of autonomy, competence and relatedness, while measures focusing on autonomy,

competence and relatedness are utilized as secondary outcomes.

The group psychotherapy format – pioneered by Yalom and colleagues – was adopted

[41], instead of a one-to-one psychotherapy session. Through providing a platform for

interpersonal interaction between peers with similar life experiences [41], group psychotherapy

enables social learning, a normalization of experiences, and mutual validation among the group

[32]. This fulfils the supportive-expressive intent of the intervention. A practical advantage of

the group format is its capacity to reach out to a larger number of caregivers, in comparison with

individual psychotherapy.

Content of intervention. Topics were tailored in response to the specific concerns of

burden, physical/practical concerns, emotional reactivity, self-needs and social support endorsed

by Singaporean caregivers on the CQOLC in the study mentioned earlier [38]. The content of

each session is described here:

Week 1: Coping with the diagnosis, through general coping skills, normalizing of

personal reactions and dealing with uncertainty

Week 2: Behavioral change, through self-care, stress management and mindfulness

concepts

Week 3: Cognitive change, through challenging negative thoughts and re-interpretation

of events

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Week 4: Managing emotions, through handling emotional reactivity using self-soothing,

safe-place imagery and distraction

The more intense, sensitive topics are kept till later, so that caregivers can become more

familiar with the structure of the sessions, and with one another.

Study setting for recruitment and data collection

Subjects recruited are caregivers who are accompanying their care recipients for

outpatient consultations at NCIS, where the intervention is also held at.

Recruitment

Research assistants (RAs) will approach family members accompanying patients at the

waiting areas of the clinic and provide them with a flyer and introduce the study in brief. If

interested, family members are provided with a Participant Information Sheet that provides more

details of the study. Those who are keen to participate will be asked to leave their contact details

(phone number) with the RA who will first verify the eligibility against a checklist, before

subsequently confirming the availability and register the caregiver in the next available support

group session.

Outcomes

Measurements will be taken at baseline (Time 1), immediately after the 4-week

intervention (Time 2), and at 4 weeks (Time 3) and 8 weeks (Time 4) post-intervention.

Assessment will comprise self-report questionnaires (as listed below) and a qualitative

component (interviews) undertaken only with intervention participants at Time 1 and at Time 2.

Administered at all 4 time points, self-report questionnaires will consist of: QOL, stress level,

basic psychological needs, depressive and anxiety symptoms.

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QOL, depressive and anxiety symptoms are primary outcomes; stress level, basic

psychological needs and caregiving motivations are secondary outcomes.

QOL. This is measured using the Caregiver Quality of Life-Cancer (CQOLC) Scale [42],

designed to measure the QOL of family caregivers of patients with cancer. It comprises 35-items

and yields a single QOL score. The items are scored on a 5-point Likert scale ranging from 0

(not at all) to 4 (very much). Scores range from 0 to a maximum of 140. Higher scores indicate

better QOL and the scale has good psychometric properties [42].

Anxiety and depressive symptoms. The Hospital Anxiety and Depression Scale (HADS)

[43] is a widely used self-rated 14-item questionnaire. Participants indicate which of four options

from 0 to 3 – with 3 indicating higher symptom frequency – best describes their feelings over the

past week. Anxiety and depressive symptoms are scored on separate subscales of 7 items each.

Scores range to a maximum of 21 for each subscale and good psychometric properties are

frequently reported [44].

Basic psychological needs. The Basic Psychological Needs in General Scale (BPNS)

contains 21 items that measure the degree to which people experience the basic psychological

needs in their lives. It is divided into subscales measuring a need for autonomy (7 items),

competence (6 items) and relatedness (8 items) with each item measured on a seven-point scale

from 1 (not at all) to 7 (very true). A previous study using the original scale found acceptable to

excellent psychometric properties [45] for the full scale (α = .89), and its subscales of autonomy

(α = .69), competence (α = .71) and relatedness (α = .86).

A shortened version is used in this study to reduce burden of completion and fatigue

amongst participants completing the study questionnaire. Previous studies have employed

various brief versions containing either 9 or 15 items, with good psychometric properties.

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Fifteen-item versions of the scale demonstrate acceptable reliability (α = .79 to .87) [46, 47] and

studies have worked with only 9 items, namely, 3 items per subscale [48–50]. This study uses a

modified version of the 9-item short scale [48–50]. One item (“I get along with people I come

into contact with.”) was replaced with another item from the original scale (“I really like the

people I interact with”) based on recommendations that wording in scale items be as specific,

concrete and non-ambiguous as possible [51]. The 9-item questionnaire has three subscales with

three items each: autonomy, competency, and relatedness. Participants were asked, based on

their role as a caregiver in the past month, the degree to which they agree with the statements on

a 7-point Likert-type scale from 1 (not at all) to 7 (very true).

Stress. The Perceived Stress Scale is originally a 14-item scale [52] developed as a global

measure of stress. To reduce participants’ response burden, we used the PSS-10, a 10-item short

version with high reliability and validity [53]. It requires participants to indicate how often they

have experienced each of the statements in the last month on a five-point scale from 0 (never) to

4 (very often). Scores are obtained by reversing responses to the positively stated items and then

summing across all scale items. It has been used to assess stress amongst Singaporean adults and

has good reliability coefficients [54].

Qualitative Interviews. Semi structured interviews will be conducted to allow deeper

insights into the lived caregiving experience, beyond the information gathered using

questionnaires. An interview guide will be used to explore issues on caregiving duties; needs and

challenges of caregiving, the reasons and motivation pertaining to taking up the caregiving. At

Time 2 questions will be added to explore participants’ experience and feedback with the

intervention. Interview topics (questions and probes) will be used flexibly to allow participants to

share issues of importance to their experience.

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At Time 1, interview questions will focus on the goals and motivations of caregiving

(Example: “Why do you give care to your loved one?”), the nature of the caregiving relationship

(Example: “How would you describe your relationship with your loved one?”, and challenges

faced in caregiving (Example: “What challenges do you face in caring or your loved one? How

have you coped with these challenges?”).

At Time 2 (post intervention), a similar interview guide will be used to explore how

caregiving experience or motivations may have changed (Example: “Since the last time we

spoke, how have your ideas about your goals and motivations changed?”) in addition to

questions to get feedback on the intervention program (Example: “What have you learnt from the

intervention and from interacting with the group?”).


Prior information on support group interventions for caregivers is largely lacking in

Singapore and as a pilot study, hence we are unable to compute a sample size. Nonetheless,

based on the sample sizes of similar studies conducted locally and overseas [31, 33, 55, 56], as

well as what is deemed feasible within the available timeframe and resources, we aim to recruit

120 participants in total, with 60 participants for each arm.

Allocation of participants to study arms

This study follows a quasi-experimental design to accommodate participants’ schedules

and preferences; as such consenting participants are assigned to either study condition based on

their availability and preference instead of using randomization. Upon consent, caregivers can

enter either of two conditions: the intervention group or the control group, which is waitlisted.

Available caregivers are placed in the first group (Group 1a) until a group size of ten is reached.

The next ten will be put on a wait-list and form the control group (Group 1b), who will still be

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able to benefit from the program at a later time. In this manner, subsequent treatment and control



administered before the start of the first support group session (Time 1). At the final session,

after 4 weeks, participants complete a second questionnaire (Time 2) and are handed a packet of

two follow-up questionnaires (Time 3 and Time 4) with stamped envelopes addressed to the

Principal Investigator. These are to be returned after completion at the one- and two-month

follow-up assessment points.

The RA meets participants on the wait-list control group separately to get the informed

consent and complete the first questionnaire.

An inconvenience fee of $15 is paid to each participant after completion of each support

group session. Participants in the waitlist control arm are paid $15 upon receipt of their

completed questionnaire.

Missed sessions. To accommodate caregivers’ schedules, participants who are unable to

make it for one or more sessions are permitted to complete the session they had missed in a

following month; that is, if a participant missed Session 2 of the intervention, they could

complete the other sessions first before completing Session 2 in a following month.

Qualitative interviews. A subset of 20 participants from the intervention arm will be

interviewed twice – once at Time 1 before the intervention starts, and the second time at Time 2.

Data management

Each participant will be assigned a unique subject identification number so that they can

be tracked anonymously throughout. The trial data will be entered into an SPSS database by the

RAs.

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Outcomes will be analysed at Time 2, Time 3 and Time 4. Participants will be assessed

on an intention-to-treat basis. To examine changes between groups (intervention versus control)

on baseline and follow-up assessments, ANCOVA will be performed for each outcome measure.

Demographic and casemix differences between the groups that are significant confounds will be

entered as covariates. Alternatively, Latent Growth Modelling might be considered, depending

on the quality of the data obtained.

In addition, a “per protocol” analysis will be conducted to examine caregivers who were

able to complete all four sessions of the intervention arm.

No formal subgroup analyses are planned but exploratory analyses of the caregiver

demographics (e.g. age range, ethnicity, income level) and the disease characteristics of the care

recipient (e.g. cancer type, cancer stage) on the effect of the intervention will be carried out.

DISCUSSION

Although support group interventions have had a significant positive impact on multiple

outcomes [57], there is a paucity of research on caregiver populations in Asia. The majority of

studies have been mainly conducted on female, Caucasian caregiver populations [58]. Studies of

the Asian caregiving experience are few and far between [59–61]. Moreover, research on

caregivers in Singapore is concentrated on dementia and elderly care recipients [62, 63].

However, with rising prevalence of non-communicable chronic diseases such as cancer and

depression [64, 65], there is a greater need for research on how caregivers in Asia are impacted

and cope. The common finding that depression prevalence is higher amongst Asian caregiver

populations than Western caregiver populations suggests the possibility that Asian populations

may experience a greater burden of caregiving.

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Group-based approaches may provide cost-effective means of providing mental

healthcare. However, few studies have examined the impact of support groups on family

caregivers. Only two of 29 RCTs reviewed in a meta-analysis conducted caregiver-only groups

[57]. Group-based interventions are of interest because they are more cost-effective than one-on-

one counselling in providing structured support. Moreover, feedback has been generally positive.

Caregiver-focused groups were rated as providing skills such as information and support that

reduced the negative appraisal of caregiving, decreased uncertainty, and lessened hopelessness,

while also teaching skills to cope with the stresses of caregiving [66]. This supports suggestions

that such groups might give caregivers the chance to openly interact with other caregivers in the

absence of their care recipients [57]. Moreover, in a systematic review of psychosocial

interventions, group-based or otherwise, caregivers listed the most useful aspect of interventions

as regular interactions with a professional, providing the chance to openly communicate issues

with them and as a time to talk about feelings and questions related to cancer [13, 66].

There is also a need to expand qualitative understandings of how a support group is

received in cultural contexts which are not attuned to support groups, much less one for cancer.

In Singapore, cancer is still seen as a terminal disease with little hope of recovery, and there is

also a stigma against psychological counselling and psychiatric support, facilitated by the general

stigma against mental illness amongst both patients and paradoxically, healthcare professionals

[67]. Furthermore, a family–centred model of decision-making tends to be predominant in Asian

populations [68], and in Singapore, this is further encouraged by public policy such as healthcare

subsidies that are based on a calculation of the immediate family’s total income, rather than

individual income [69]. Beliefs or expectations of the role the family caregiver ought to play may

thus exist and may influence the way individuals respond to the intervention.

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With the rising trend of cancer and other non-communicable diseases, the global disease

burden will be increasingly shouldered by chronic, outpatient care. Much of this will involve the

immediate family and bring with it costs to caregiver well-being. Effective short-term

interventions are needed to provide support to caregivers managing busy schedules.

However, the current trial does pose methodological challenges in recruiting and ensuring

attendance for all consecutive sessions of the support group. To accommodate caregivers’ needs,

caregivers will make up for sessions they miss in follow-up sessions. These will be taken into

account in data analysis.

Limitations

Because the study design accommodates participants’ preferences and availability, a self-

selection process into either the intervention or control arm may occur. Those who decline to

attend may be more stressed due to multiple commitments, but yet are in greater need of the

support. Because those who attend are possibly better adjusted caregivers, a ceiling effect may

result when evaluating the effectiveness of the program, hence understating its actual

effectiveness. This can be corrected for by comparing the baseline characteristics of both study

arms during data analysis.

Another limitation is the restriction of the intervention to only English-speaking

participants. This excludes the segment of non-English speaking caregivers, who may have

different supportive needs. Generalizability of the findings is thus limited to only English-

speaking caregivers.


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Informed consent will be obtained from all participants and confidentiality of the issues

raised during the support group will be maintained strictly. All data will be anonymised and

maintained in accordance with the guidelines stated by the NHG DSRB.

Dissemination of findings will include presentations at conferences and publications in

peer review journals.

Competing interests


Funding

The National University Cancer Institute, Singapore Centre Grant FY2013-2016, Seed Funding

Program supported the study.


HYN and JT coordinated the support groups and administered the questionnaires. HYN

conducted the interviews. JT also helped to draft the manuscript. KG advised on study

methodology, statistical analysis and helped to draft the manuscript. HL participated in the

design of the study and will be conducting statistical analysis. JC conducted the support groups.

RM and EHK conceptualized the study, and participated in its design and coordination and

helped draft the manuscript. SEL was involved in study design and facilitating the conduct of the

study at the National University Cancer Institute, Singapore. All authors read and approved the

final manuscript.

REFERENCES



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CONSORT 2010 checklist Page 1

CONSORT 2010 checklist of information to include when reporting a randomised trial*

Section/Topic Item No Checklist item

Reported on page No

Title and abstract

1a Identification as a randomised trial in the title 1

1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 3

Introduction

Background and

objectives

2a Scientific background and explanation of rationale 5-8

2b Specific objectives or hypotheses 8

Methods

Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 8

3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons -

Participants 4a Eligibility criteria for participants 9

4b Settings and locations where the data were collected 12

Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were

actually administered

11-12

Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they

were assessed

12-15

6b Any changes to trial outcomes after the trial commenced, with reasons -

Sample size 7a How sample size was determined 15

7b When applicable, explanation of any interim analyses and stopping guidelines -

Randomisation:

Sequence

generation

8a Method used to generate the random allocation sequence 15

8b Type of randomisation; details of any restriction (such as blocking and block size) -

Allocation

concealment

mechanism

9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers),

describing any steps taken to conceal the sequence until interventions were assigned

-

Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to

interventions

15

Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those -

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assessing outcomes) and how

11b If relevant, description of the similarity of interventions 10-11

Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 17

12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 17

Results

Participant flow (a

diagram is strongly

recommended)

13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and

were analysed for the primary outcome

-

13b For each group, losses and exclusions after randomisation, together with reasons -

Recruitment 14a Dates defining the periods of recruitment and follow-up -

14b Why the trial ended or was stopped -

Baseline data 15 A table showing baseline demographic and clinical characteristics for each group -

Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was

by original assigned groups

-

Outcomes and

estimation

17a For each primary and secondary outcome, results for each group, and the estimated effect size and its

precision (such as 95% confidence interval)

-

17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended -

Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing

pre-specified from exploratory

-

Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) -

Discussion

Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 19

Generalisability 21 Generalisability (external validity, applicability) of the trial findings 19

Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 17-19

Other information

Registration 23 Registration number and name of trial registry 4

Protocol 24 Where the full trial protocol can be accessed, if available 4

Funding 25 Sources of funding and other support (such as supply of drugs), role of funders 20

*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also

recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials.

Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.

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A Pilot, Quasi-Experimental, Mixed Methods Investigation into the Efficacy of a Group Psychotherapy Intervention for

Caregivers of Cancer Outpatients – The COPE Study Protocol

Journal: BMJ Open

Manuscript ID: bmjopen-2015-008527.R2


Date Submitted by the Author: 24-Aug-2015

Complete List of Authors: Mahendran, Rathi; National University Health System, Psychological Medicine Tan, Joyce; National University of Singapore, Psychological Medicine

Griva, Konstadina; National University of Singapore, Psychology Lim, Haikel; National University of Singapore, Psychological Medicine Ng, Hui Ying; National University Hospital, Psychological Medicine Chua, Joanne; National University Hospital, Psychological Medicine Lim, Siew Eng; National University Cancer Institute, Singapore, National University Health System, Kua, Ee Heok; National University Health System, Psychological Medicine


Mental health

Secondary Subject Heading: Research methods, Oncology, Evidence based practice

Keywords: MENTAL HEALTH, ONCOLOGY, PSYCHIATRY, QUALITATIVE RESEARCH


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A Pilot, Quasi-Experimental, Mixed Methods Investigation into the Efficacy

of a Group Psychotherapy Intervention for Caregivers of Cancer Outpatients

– The COPE Study Protocol

R Mahendran, JYS Tan, K Griva, HA Lim, HY Ng, J Chua, SE Lim, EH Kua



Research Assistant2

Konstadina Griva, PhD Associate Professor4

Haikel Asyraf Lim, BSocSci (Hons) Research Assistant2

Hui Ying Ng, BSocSci (Hons)

Research Assistant1

Joanne Chua, BSc (Hons), MSc, MPsy (Clinical)



Senior Consultant4 and Clinical Director, Department of Haemotology-Oncology5 Ee Heok Kua, MBBS, MD, FRCPsych





3 Duke-NUS Graduate Medical School Singapore, 8 College Road, Singapore 169857 4 Department of Psychology, National University of Singapore Block AS4, #02-07 9 Arts Link Singapore 117570 5 National University Cancer Institute, Singapore, National University Health System


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Ms Joyce Tan Department of Psychological Medicine, National University of Singapore NUHS Tower Block, Level 9 1E Kent Ridge Road, Singapore 119228 Email: [email protected] DID: +65 6772 3496 Fax: +65 6777 2191 Keywords: Neoplasms/psychology*, Stress, Psychological/therapy*, Caregivers/psychology*,

Psychosocial intervention, Mixed methods, Support group

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ABSTRACT

Introduction: Despite the rising trend of cancer prevalence and increase in family caregiving,

little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver

samples, particularly support groups, given the benefits that have been shown in studies on

Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week group

psychotherapy for Singaporean family caregivers of patients receiving outpatient care.

Methods and Analysis: Facilitated by a clinical psychologist, this intervention is primarily

based on the Brief Integrative Psychological Therapy, with a supportive-expressive intent.

Participants will be recruited while they are accompanying their care recipients for outpatient

consultations. Because this is a pilot study, a sample size of 120 participants is targeted based on

sample sizes of previous studies. The study adopts a quasi-experimental design, as participants

are assigned the intervention or control arms based on their availability to attend the intervention.

A mixed methods approach is used to evaluate the outcomes of the intervention. A self-

administered battery of tests is completed at four time-points: baseline, post-intervention, and

follow-up at one- and two-months post-intervention; semi-structured interviews are conducted at

baseline and post-intervention. Primary outcomes are quality of life, anxious and depressive

symptoms; secondary outcomes are stress and basic psychological needs. Analysis using

ANCOVA would be conducted to determine the effectiveness of the intervention.

Ethics and Dissemination: This study protocol has ethics approval from the National

Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written

informed consent is obtained from every participant. Results will be disseminated through

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journals and conferences, and will be particularly relevant for clinicians intending to implement

similar support groups to address the psychosocial concerns of caregivers, as well as for

researchers seeking to refine the structure and evaluate the effectiveness of such programs.

Trial registration: Current Controlled Trials NCT02120183

(https://clinicaltrials.gov/show/NCT02120183)

Strengths of the study:

• The intervention here catering to caregivers of ambulatory cancer patients expands the limited work done among Asian caregivers on support group interventions.

• 4-week psycho-social intervention builds on previous programs and approaches developed for local caregivers, and hence directly addresses their concerns.

• The complementary strengths of the quantitative and qualitative data collection methods employed here provides a comprehensive understanding of the daily caregiving experience and the effectiveness of the support group.

Limitations of the study:

• Self-selection bias into study conditions may influence the evaluative outcomes, understating the actual effectiveness of the intervention.

• There is no restriction on the cancer type or stage of participants’ care recipients, which may influence the psychological outcomes reported on the various measures, in addition to the intervention.

• Restriction to English-speaking participants for the intervention may limit the generalizability of the findings.

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