assessment of quality of life in breast cancer
TRANSCRIPT
Acta Oncologica Vol. 34, No. 5, pp. 689-694, 1995
ASSESSMENT OF QUALITY OF LIFE IN BREAST CANCER
LESLEY J. FALLOWFIELD
Effective treatment for breast cancer can produce a reasonably good ten-year survival rate in comparison to many other cancer sites. Nevertheless, the potential psychological, sexual and physical dysfunction caused by both the diagnosis and treatments can have a deleterious impact on the quality of a woman’s life. The range of possible treatments may have similar outcomes in terms of response and survival, but can produce very different effects on emotional well-being. Therefore, monitoring quality of life in breast cancer should be a mandatory part of follow-up in clinical trials. Data derived from various studies of quality of life can also be used to assist the doctor and patient in decision-making about treatment options. Furthermore, assessment of quality of life can help identify those patients who might profit from psychosocial interventions. In this paper some of the instruments used to assess quality of life in breast cancer will be discussed.
Over the past few years there has been a proliferation of research papers delineating the deleterious impact that both the diagnosis and treatment of breast cancer can have on the quality of a woman’s life. Concurrently, the past decade has seen the development of literally hundreds of tests purporting to measure health-related quality of life or some aspect of it. These instruments may range in length from those containing merely one or very few items to others with over a hundred questions (1). Few clinicians would now doubt the importance of measuring quality of life. Indeed, most would argue that in cancer care in particular improving quality of life is the primary goal of treatment; consequently they make implicit judgements about the effect of treatment continually. However, the development of appropriate psychometric tests now makes more formal assessment possible, but how can the inter-
Received 8 June 1994. Accepted 12 June 1994. From the CRC Communication & Counselling Research Centre, University College London Medical School, Department of On- cology, London, England. Correspondence to: Dr LJ Fallowfield, CRC Communication & Counselling Research Centre, University College London Medical School, Department of Oncology, 3rd Floor, Bland Sutton Insti- tute, 48 Riding House Street, London WIP 7PL, England Presented at the 5th Scandinavian Breast Cancer Symposium, May 28-June 1, 1994, Reykjavik, Iceland.
ested clinician choose between the many tests available? The answer to this question really depends on the purpose to which data will be put. For example, a clinician inter- ested in an instrument which might help screen those women most in need of counselling support might well choose something very different from another interested in clinical trials or another involved with health technology assessment who may require data to help inform health- care policy decisions or resource allocation.
Following a brief description of some of the areas of quality of life most compromised by breast cancer, the present paper will discuss the various instruments available for assessment and offer some guidelines about choosing instruments.
Primary effects on quality of life in breast cancer
The many psychological, social, functional and sexual problems associated with the diagnosis and treatment of breast cancer have been well-described in the medical literature and lay press. Seminal work conducted in the 1950s reported that anxiety and depression, together with impairments in physical and sexual functioning, were com- mon sequelae of mastectomy which was then the primary treatment available for breast cancer (2, 3). This early work was based upon anecdotal evidence, but later con-
0 Scandinavian University Press 1994. ISSN 0284-186X 689
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L. J. FALLOWFIELD Acta Oncologica 34 (1995) 690
trolled studies (4, 5) comparing psychological outcome in women with either malignant or benign breast disease showed that psychiatric morbidity, self-esteem and body image problems were prominent features post-mastectomy.
The mid to late 1970s showed an upsurge of interest in breast conserving surgery and when data from randomised trials emerged showing no survival differences between women treated by mastectomy or breast conservation and radiotherapy (6), surgeons expressed the intuitively reason- able hopes that they could offer women surgery which would not compromise survival and which would improve quality of life.
Many studies have now been published showing that those hopes have not been realised (7, 8). Comparison between different studies is difficult, due to differences in focus, sampling procedures, timing of assessments and quality of life instruments employed. However, overall anxiety and depression in women are equivalent irrespec- tive of primary surgery given. Rates vary, but in general between a quarter and a third of women experience signifi- cant degrees of anxiety and depression likely to diminish other aspects of quality of life whatever form of surgery they undergo. Had we relied upon intuition alone rather than used formal assessment measures, it seems unlikely that these counter-intuitive findings would have emerged for some time.
There are, of course, some advantages accruing to some women who have breast conserving surgery; for example, those with a very strong sense of self predicated on physi- cal attractiveness, for whom integrity of body image is vital, may be completely devastated by mastectomy. Con- versely, other women may find radiotherapy after breast conserving surgery extremely stressful, dislike the length of treatment and be unhappy with the resultant cosmetic effects. Furthermore, some women find the uncertainty and fear of local recurrence outweighs the advantages of preserving body image (9). Findings such as these show how important it is to look at both aggregated and disag- gregated scores from different domains in quality of life instruments, as although one woman may well be dissa- tisfied with her body image, she could be functioning well in other domains, while another woman might find that her altered body image impinges significantly on her social and sexual life.
Having looked very briefly at some of the quality of life issues important to women with breast cancer, I now want to discuss some of the assessment measures available. Commonly used measures in breast cancer include various generic, domain specific and cancer specific tests.
Generic tests
Generic tests are appealing to researchers interested in comparisons of quality of life across different disease states. They have usually undergone considerable testing to
establish reliability and validity and norms for different populations may be available. Examples of generic tests include such things as the General Health Questionnaire (GHQ) (10).
This instrument has three versions, with 28, 30 or 60 items, and was originally designed to screen populations for psychiatric and social morbidity. The GHQ-28 has four subscales, assessing depression, anxiety, social functioning and physical symptoms and scoring is relatively quick and simple. The GHQ has good reliability and has been satis- factorily validated against clinical interview schedules. However, as the instrument was designed for use with non-physically-sick populations, it has been suggested that higher thresholds to determine caseness should be used with physically sick patients, for example in women with breast cancer undergoing cytotoxic chemotherapy ( 1 1).
Another example of a generic test gaining in popularity is the Medical Outcomes Short-form 36 (MOS SF-36) (12). This relatively brief but comprehensive and psychometri- cally sound questionnaire was developed for use for a variety of different purposes, such as general population surveys, for health policy evaluations as well as clinical practice or research in clinical trials. The 8 subscales measure 1) physical functioning; 2) impairment to role activities (due to health), 3) pain, 4) psychological well- being, 5) impairment to role activities (due to psychologi- cal problems), 6) social functioning, 7) energy and fatigue, and 8) general health perceptions. The SF-36 can be administered as a self-report questionnaire or by a trained interviewer, which might be useful in advanced cancer if patients are too ill to complete forms. Currently an inter- national team is translating the questionnaire into 15 different languages and is also working on a utility index for economic evaluations ( 13).
The Nottingham Health Projile (NHP) (14) was devel- oped originally as a survey tool, but has been used increas- ingly to evaluate the outcome of medical interventions (15). The authors conducted many research projects to refine their instrument, producing evidence of its reliability and validity. The NHP is divided into two parts-one has 38 statements subdivided into 6 problem areas: energy pain, emotional reactions, sleep, social isolation and phys- ical mobility; the other has 7 statements concerned with areas of daily life, hobbies, interests, and holidays.
Although the instrument has proved popular and been widely used, there are problems. For example, it only looks at negative aspects of health, making it impossible for patients to indicate well-being accurately. Zero scores do not necessarily reflect the absence of problems; thus, the profile may not detect relatively small but nevertheless significant areas of distress. The NHP was an innovative instrument, but has now probably passed its sell-by date. Indeed, Sonja Hunt herself does not regard it as an appropriate tool for assessing the quality of life (Hunt personal communication, 1993).
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QUALITY OF LIFE IN BREAST CANCER 69 1 Acta Oncologica 34 (1995)
One of the most comprehensive generic tests developed is the Psychological Adjustment to Illness Scale (PAIS) ( 16). Originally a semi-structured interview, administered by trained doctors, nurses, psychologists or social workers, it is now used most often in its self-report version. The PAIS has 45 questions looking at a patient's global adjust- ment to illness in seven important areas affecting quality of life: 1) health care orientation, 2) vocational environment, 3) domestic environment, 4) sexual relationships, 5) ex- tended family relationships, 6) social environment, 7) psy- chological distress. Comprehensive coverage such as this, however, is not without its costs. The test takes patients approximately 30 min to complete and scoring is quite complex. There are norms available for comparison across a variety of patient populations such as cardiac, renal and cancer patients.
Domain specific tests
Some generic measures do not contain sufficient items to measure domains which might be crucial to someone un- dergoing treatment for cancer. Thus, one of the domain specific tests might be added, such as those questionnaires looking at psychological morbidity. An example of this would be the Profile of Mood States (POMS) (1 7 ) , which measures an individual's current emotional state by asking subjects to rate how applicable 65 different mood descrip- tions are to them. There are 6 different subscales on the POMS: tension, depression, anger, vigour, fatigue, and confusion. It has been used in clinical trial work, but is probably of more value in charting the benefits of psycho- social interventions, e.g. Spiegel et al. (18) showed that women in a professionally led self-help group with ad- vanced breast cancer showed significant improvements over controls in negative feelings of anxiety, tension, fatigue, and confusion.
Another commonly used domain specific test for psy- chological morbidity is the Hospital Anxiety and Depres- sion Scale (HADS) (19), which was designed specifically for use with physically sick populations. The two sub- scales, for anxiety and depression, do not include items of a somatic nature, for example weight loss, which could be caused by cancer as much as mood disturbance. Each subscale has 7 items, rated on a four-point scale, so it is extremely quick to administer, complete and score. Valida- tion against the Clinical Interview Schedule shows that it has satisfactory sensitivity and specificity (20). The HADS has been translated into many different languages, includ- ing more European, Japanese and some Asian languages. Thus, it can be used with multi-ethnic populations or in cross-cultural studies.
An example of a domain specific test looking at physical function would be something like the Karnofsky Perfor- mance Scale (KPS) (21), although I hesitate to describe this as a quality of life measure. Nevertheless, the KPS is
a widely used scale of functional performance applied to oncology patients. It does have some prognostic use as scores pretreatment tend to correlate well with survival. Another similar domain specific example is the WHO Performance Status. The WHO 5-point scale is physician rated with patients fully active and well scoring 0, whilst those completely disabied score 4.
One of the many problems with physician-rated 'quality of life' instruments that rely entirely upon assessment of physical functioning is the assumption that a patient with a lowish score due to immobility necessarily has a poorer quality of life than a patient with a higher score. A breait cancer patient, for example, recovered from her operation and having finished adjuvant therapy would receive a fairly high score. However, she might be so emotionally crippled by depression and a concomitant loss of libido and self-esteem that her quality of life would be extremely poor.
Cancer specific tests
Oncology has led the way in quality of life research and the past decade has seen the development of many cancer specific instruments, such as the Functional Living Index- Cancer (FLIC) (22). This multidimensional instrument comprising 22 questions rated on a visual analogue scale with specific questions designed to assess the overall func- tional quality of a cancer patient's day-to-day life, includ- ing items related to pain, stress, the ability to work and to do household chores. As with all visual analogue scales scoring can be time consuming. Some authors have sug- gested that as there are so few items measuring each dimension of quality of life, its ability to measure signifi- cant change over time may be poor. Consequently, it is not recommended for clincial trial work (23).
A very much more comprehensive questionnaire is the Cancer Rehabilitation Evaluation System (CARES) (previ- ously Cancer Inventory of Problem Situations-CIPS (24, 25). It has been validated against other standardised mea- sures of psychosocial distress, physical function, marital adjustment and quality of life. The full CARES question- naire contains 139 items, although certain subscales are only applicable to certain patients and not others. For example, only patients who have been treated within the past month answer the 9 chemotherapy related questions. The specificity of the instrument highlights those areas of psychosocial functioning of most concern to patients, thus its main value is to provide detailed information about potential rehabilitation needs. Furthermore, patients are invited to indicate those problems with which they would like some help.
Rotterdam Symptom Checklist (RSCL) (26) was de- signed specifically to measure the toxicity and impact that treatment for cancer was having on psychosocial function- ing or quality of life. In the core instrument 30 items can
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L. J. FALLOWFIELD Acra Oncologica 34 (1995) 692
be divided into two primary subscales measuring both physical and psychosocial dimensions. There are vers- ions which include additional items for specific can- cer sites; for example, a breast cancer version in- cludes items concerned with body image. The sensit- ivity and specificity for the psychological items on the scale have been validated against trained interviewer ratings in advanced breast cancer patients (20). The test is extremely easy to understand and patients find it quite acceptable (27).
The European Organisation for Research and Treatment of Cancer (EORTC) has developed a multidimensional self-assessment questionnaire to assess quality of life in heterogeneous groups of cancer patients (28). The EORTC QL Core 30 questionnaire assesses functioning in physical, psychological and social domains. There are many different groups in Europe developing specific mod- ules which contain other items addressing issues particu- larly relevant to different cancer sites, including breast. The authors are evaluating and refining their instrument with meticulous care (29) and it is hoped that this will result in a major breakthrough in the standardisation of assessment methods in cancer clinical trials.
Choosing a quality of life instrument in breast cancer
I have already mentioned that choosing a questionnaire really depends on the primary use that will be made of the data collected. There are 4 main reasons: 1) to assist doctor and patient in decision-making, 2) in clinical trials, 3) to identify women at risk of developing psychosocial problems, and 4) for economic analysis and resource allocation.
To assist in decision-making
As I have already discussed, there is no difference in survival between surgical options (6), or psychol- ogical morbidity; thus, women may be offered the choice between breast conservation and mastectomy (30). Good information about the general quality of life considerations can assist decision-making and pre-treatment assessment of individual women can help health-care professionals in providing the best avail- able support and advice. For example, Ward et al. (31) looked at factors influencing women’s decision about surgery. The primary concern to women who opted for mastectomy was the desire to avoid time off work and other side-effects, necessitated by radiotherapy treat- ment, whereas women who chose lumpectomy had the desire to maintain ‘body integrity’ as their primary concern. They seemed prepared to trade off the inconve- nience of radiotherapy treatment for preservation of body image.
Widening parameters of benefit in clinical trials
Quality of life as an important outcome measure in clinical trials of surgery for breast cancer, as I have already mentioned in reference to the Breast Conservation Study (7). Another example can be seen in a study reported by Bates et al. (32). They used the GHQ-28 to determine the quality of life of elderly women treated with tamoxifen alone or tamoxifen and optimal surgery. Quality of life assessment may also be useful in an adjuvant chemother- apy setting and there are data emerging showing the predictive value of quality of life assessment. For example, in a study reported by Fraser et al. (33) comparing differ- ent chemotherapeutic drugs and routes of administration in women with advanced breast cancer, no single factor pretreatment predicted either response or survival more accurately than the patient’s initial quality of life scores.
If quality of life variables are to be used as valid endpoints along with response, toxicity and survival, then it is vital that the choice of test should be decided at the time that protocols are being designed. Quality of life assessment requires the same scientific rigour that is ap- plied to other laboratory or clinical outcome measures. Thus, it must be properly integrated into the protocol, not merely added as an afterthought as has happened too often in the past. Furthermore, adequate resources must be provided to permit accurate data collection and analysis. This supposed ‘softness’ of quality of life data is more often a reflection of the lackadaisical fashion in which the tests have been chosen, or methods of data collection, rather than problems intrinsic to the measures themselves.
Identification of patients at risk to developing psychosocial problems
It is well known now that approximately a third of all women treated for breast cancer will experience significant psychiatric morbidity during the first three years of treat- ment (34) and that, if these problems can be identified early, counselling intervention may help (35). The problem is finding a reliable means of identifying those women most at risk of developing psychological difficulties. At least three studies have shown that it is possible to use standardised measures to identify factors pre-operatively in patients most at risk (36-38). In particular, those patients with a clear history of depression and a high number of significantly stressful life events occurring prior to diagno- sis are very likely to be strong indicators of the risk of development of high psychological distress.
To inform economic analysis and health care policy
Undoubtedly, cost utility analysis (CUA) is becoming an increasingly important means of rationing/distributing scarce healthcare resources and the generation of so-called
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693 Aria Oncologica 34 ( 1995) QUALITY OF LIFE IN BREAST CANCER
quality adjusted life years (QALYs) form part of CUA. Many criticisms have been made of the manner in which QALYs are generated (39, 40). One problem has been that most QALYs take a macro look at health status valuations based on professional judgements or those of people gener- ally disease-free; they have very little to d o with a sick individual’s quality of life. The terms ‘quality of life’ and ‘QALY’ are confusing and this is more than just a ques- tion of semantics. There is clear distinction between the sort of quality of life measures used in most research and clinical work and those that tend to be used for the generation of QALYs. The problem is not simple and the issues need to be explored much more fully because the consequences of using quality of life estimates in resource allocation are scientifically and ethically complex. This debate is important, but beyond the scope of this paper.
Conclusions
The measurement of quality of life which can assist decision-making, provide valuable data in clinical trials and identify women who need psychosocial interventions has not been applied as successfully yet in economic evalu- ations. Some general suggestions can be made about choice of quality of life instruments for the first three purposes described. In particular, the EORTC QLQ Core 30, RSCL and CARES would seem to be particularly useful in breast cancer research and for clinical work.
Surveying the literature in the quest for an off-the-shelf questionnaire can be a daunting prospect. Nevertheless, investment of time in choosing the right one is vital. The enthusiastic researcher always has to make some compro- mise and it is probably better to use well-validated, stan- dardised measures than to add to the existing confusing pool yet another naively constructed measure, although there is no compelling reason why extra ad hoc questions designed along the standard lines and format of the ques- tionnaire chosen should not be added to address more precisely any problem( s) not satisfactorily evaluated. How- ever, this should always be done with care, to preserve the original psychometric properties of the instrument. More comments about questionnaire choice and design in gen- eral can be found in Fallowfield (41), but one of the primary problems about people constructing their own quality of life instruments is that it becomes difficult to pool data for meta-analysis or to compare outcomes across trials and disease states. Many good quality of life tests now exist with established psychometric properties. so we should invest time in seeking them out and utilising them. Just as a poorly manufactured or calibrated medical in- strument would have unfortunate consequences for pa- tients, data derived from inadequate unvalidated quality of life questionnaires could have a detrimental effect in breast cancer care.
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