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Role of Health-Related Quality of Life in Palliative Chemotherapy Treatment Decisions

From the Division of Psychosocial Research and Epidemiology and Department of Medical Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.

Address reprint requests to Neil K. Aaronson, PhD, Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands; email: naaron{at}nki.nl

	ABSTRACT

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PURPOSE: To determine the frequency with which health-related quality-of-life (HRQL) considerations lead to modification or discontinuation of palliative chemotherapy, and the association between physicians’ ratings of patients’ HRQL and such treatment decisions.

METHODS: Four consecutive medical consultations of 203 patients receiving outpatient palliative chemotherapy were tape-recorded and the content was analyzed to determine the frequency of and reasons for treatment alterations. Physicians rated their patients’ HRQL by using the COOP/WONCA health assessment charts. Data on tumor response and treatment toxicity were obtained from the audiotapes and, when necessary, were confirmed by medical chart audits.

RESULTS: Treatment was modified in 54 cases (26%) and discontinued in 40 (20%). The primary reasons for modifying treatment were toxicity (n = 22), HRQL considerations (n = 18), and tumor progression (n = 14). The primary reasons for discontinuation of treatment were tumor progression (n = 23), HRQL considerations (n = 6), and toxicity (n = 3). For eight patients, a combination of tumor progression and HRQL issues resulted in discontinuation of treatment. Treatment decisions were associated significantly with physicians’ global ratings of patients’ HRQL but not with more specific HRQL domains. In the presence of tumor progression or serious toxicity, HRQL considerations played little or no role in treatment decisions. Furthermore, approximately 70% of patients without evidence of tumor progression or toxicity, but with seriously impaired HRQL, continued to receive their treatment as planned.

CONCLUSION: Contrary to previous findings based on physicians’ self-report data, HRQL considerations seem to play a relatively minor role in decisions regarding modification or discontinuation of palliative chemotherapy.

	INTRODUCTION

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TRADITIONALLY, the evaluation of cancer treatments has focused on biomedical outcomes, including disease-free and overall survival and treatment toxicity. Since the 1980s, however, there has been increased interest in evaluating the effect of cancer and its treatment on the patients’ health-related quality of life (HRQL), typically defined in terms of physical, psychological, and social functioning and well-being.¹ Assessment of patients’ HRQL is particularly relevant in the palliative treatment setting. Palliative chemotherapy, for example, may alleviate tumor-related symptoms such as pain or dyspnea, and this may improve patients’ HRQL. Chemotherapy may, however, also carry with it substantial physical and psychological side effects that adversely affect the patient’s HRQL.²

The benefits and burdens associated with palliative treatment need to be continually monitored and weighed in deciding whether to continue, modify, or discontinue treatment. HRQL factors are often cited as being of major importance in palliative medicine.^2-9 In a 1990 survey of more than 500 health care professionals, HRQL was rated as the most important outcome in assessing the effect of palliative chemotherapy for advanced cancer.¹⁰ In a similar survey among medical oncologists,¹¹ HRQL was ranked by 46% of the respondents as being the most important factor in deciding whether to continue palliative therapy, followed by treatment toxicity (25%) and tumor response (18%). Both of these studies, however, were based on physicians’ self-reported attitudes and behavior, which may or may not reflect the actual decision-making process in clinical practice.

This observational study was undertaken to investigate (1) the frequency with which HRQL considerations are the primary reason for modifying or discontinuing palliative chemotherapy, on the basis of actual discussions carried out between physicians and their patients; and (2) the association between physicians’ formal ratings of patients’ HRQL and such treatment decisions.

	METHODS

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Study Sample and Procedures
This study was part of a larger investigation of doctor-patient communication in the outpatient palliative chemotherapy setting conducted from June 1996 to January 1999 in the Antoni van Leeuwenhoek Hospital, a specialized cancer treatment center in Amsterdam. The physician sample included the medical staff of the Department of Medical Oncology. The patient sample comprised a consecutive series of patients receiving outpatient palliative chemotherapy who were under the care of one of the participating physicians. Inclusion criteria were the following: 18 years of age or older, having received a minimum of two cycles of chemotherapy, basic proficiency in the Dutch language, and not participating in a concurrent HRQL study. The study was approved by the institutional review board of the hospital, and all patients gave their informed consent before participation. Patients who declined to participate were asked to respond to a brief questionnaire by telephone.

Patients were observed during a maximum of four successive outpatient consultations with their treating physician. All consultations were tape-recorded. The audiotapes were analyzed by three trained raters (the first author and two experienced research assistants) by using a content checklist. Additionally, at the time of each consultation, the physicians were asked to rate the patients’ HRQL with a brief, standardized questionnaire.

Study Measures
Content checklist. All audiotapes were rated by means of a content checklist that was developed specifically for this study by the research team, including a medical oncologist (J.H.S.). Coding was performed directly from audiotape by the three raters. Group training was provided in the use of the checklist. To assess the level of interrater agreement and to resolve any problems in the rating procedures, all raters coded a random sample of 30 audiotapes (10 at the start of, 10 midway through, and 10 toward the end of the data collection period). A high level of agreement was reached (mean, 95%). Weekly meetings were held to discuss any difficulties encountered in ratings and to reach consensus in those cases.

Treatment decisions. It was determined whether the treatment was given as planned or was modified or discontinued during the study period (ie, four consecutive consultations). Treatment modification included reduction of the dose, postponement of the treatment course, or change to a milder chemotherapeutic regimen. Cessation of therapy was noted when the treatment was discontinued prematurely and no other chemotherapy was offered. In case of treatment modification or cessation, the primary reason underlying this decision, as discussed during the consultation, was noted: (1) tumor progression, (2) treatment toxicity, (3) HRQL considerations, or (4) a combination of these. To make a clear distinction in the rating procedure between treatment toxicity and HRQL considerations, the former was noted in case of signs (eg, blood values or values of liver or heart function) and the latter in case of symptoms (eg, fatigue, pain, or nausea). The HRQL category was also used when the decision was based on the patient’s level of functioning (physical, emotional, or social) or general well-being.

Ratings of tumor status and treatment toxicity. The audiotapes were also used as the primary source of information to classify all patients, including those who continued treatment, with regard to tumor response and treatment toxicity. In those cases in which the information derived from the audiotapes was at all unclear, medical chart audits were conducted. Tumor status was classified into two categories: (1) tumor progression (increase in size, number of sites, or both) or (2) stable disease or tumor regression. Toxicity was coded as either (1) serious (eg, significant bone marrow suppression or inadequate liver function) or (2) mild/none.

Ratings of patients’ HRQL. Immediately after each consultation, the physicians rated the patients’ HRQL by means of the Dartmouth Primary Care Cooperative Research Network/World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (COOP/WONCA) health assessment charts.^12,13 These charts assess HRQL at a generic level, covering a core set of domains, including physical fitness, feelings, daily and social activities, general well-being, and pain. An additional chart was included to assess fatigue. Each chart consists of a descriptive title, a question referring to a single aspect of the patient’s HRQL during the previous 2 weeks, and five response choices illustrated by drawings. Scores range from 1 to 5, with 1 representing the best and 5 indicating the worst level of functioning or well-being. The rationale for using physicians’ ratings rather than patients’ self-reports was that, despite an increased call for shared decision-making, many seriously ill patients still prefer to follow their physician’s recommendations.^14,15 Thus, the physician’s perspective and opinions are often a key factor in treatment decisions.^16,17 Additionally, previous studies have documented relatively high levels of agreement between physicians’ and patients’ ratings on the COOP/WONCA charts and have demonstrated that both physician- and patient-based ratings are responsive to changes in the patients’ health status over time.^13,18

Statistical Analysis
Frequency counts were used to calculate the number of patients for whom treatment was modified or discontinued and the primary reason cited during the consultations for doing so (ie, tumor progression, treatment toxicity, the patient’s HRQL, or a combination of these). The ² method was used to assess the bivariate association between tumor response, treatment toxicity, and physicians’ assessments of patients’ HRQL (COOP/WONCA charts) and the decision to continue, modify, or discontinue treatment. For these analyses, the five response choices of the COOP/WONCA charts were collapsed into two categories: no to mild HRQL impairment (response categories 1 to 3) versus moderate to severe HRQL impairment (response categories 4 to 5). For those patients whose treatment was modified or discontinued, the COOP/WONCA charts completed at the time of that decision were used. For those patients whose treatment was continued without modification throughout the course of the study, the COOP/WONCA charts from the last recorded visit were used. For all statistical testing, the level of significance was set at P .05.

To examine the conjoint role of tumor response, treatment toxicity, and HRQL in treatment decisions, these three variables were dichotomized as follows: (1) tumor progression, yes versus no; (2) treatment toxicity, none/mild versus moderate/severe; and (3) HRQL, good versus poor (on the basis of the COOP/WONCA "general well-being" chart). This resulted in a 2 x 2 x 2 matrix, forming eight distinct profiles (eg, stable disease/tumor regression, no/mild toxicity, good HRQL; progressive disease, no/mild toxicity, poor HRQL; and so on). For each of these profiles, the percentage of patients whose treatment was continued, modified, or discontinued was calculated.

	RESULTS

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Characteristics of the Study Sample
Of the 12 medical oncologists invited to participate, 10 agreed and two declined because of objections to having their consultations tape-recorded. The 10 participating oncologists (four women, six men) had a mean age of 44 years (range, 35 to 53 years), with an average of 11 years (range, 2 to 24 years) of experience in oncology.

Of the 382 patients asked to participate in the study, 273 agreed. Of the remaining 109 patients, 50 declined because they thought that the study would be too burdensome, 43 indicated insufficient interest or lack of time, and 16 expressed difficulty with the audiotaping. A nonrespondent analysis indicated that patients who declined to participate in the study were less well educated than those who agreed to participate (P < .01). No statistically significant differences were found between the respondents and nonrespondents with respect to age, sex, marital status, tumor site, or baseline scores on the COOP/WONCA charts.

In 61 cases, either one or more of the consultations were not recorded because of logistic reasons or the recording was of insufficient quality for analysis. In another nine cases, definitive treatment decisions were not made during the consultations but were deferred to a later telephone appointment. Because audiotapes were not made of telephone conversations, the latter patients were also excluded from the analysis. This resulted in a final sample of 203 patients with, in total, 740 tape-recorded consultations (four consecutive consultations were available for 155 patients; fewer than four consultations were available for 48 patients, primarily because of death or cessation of treatment).

The sociodemographic and clinical characteristics of the participating patients are presented in Table 1. Approximately two thirds of the patients were female, with a mean age of 56 years (range, 24 to 78 years). The patients had a wide range of cancer diagnoses, with breast cancer being the most prevalent (39%). Two thirds of the patients were undergoing first-line palliative chemotherapy.

Association Between Tumor Status, Toxicity, HRQL, and Treatment Decisions
Table 3 lists the bivariate association between tumor status, treatment toxicity, HRQL as assessed by the COOP/WONCA charts, and treatment decisions. Tumor progression (P < .001) and treatment toxicity (P < .001) were significantly associated with the decision to modify or discontinue treatment. Although the physicians’ rating of the patients’ general well-being was also associated significantly with the decision to modify or stop the treatment (P < .001), this was not the case for any of the more specific HRQL domains (ie, physical functioning, feelings, daily activities, social activities, or pain and fatigue).

	DISCUSSION

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This study investigated the role of HRQL in treatment decisions for patients receiving palliative chemotherapy. Such a study, based on a large sample of patients and using audiotapes of doctor-patient consultations, has not been performed previously.

HRQL considerations were found to be the primary reason either to modify or discontinue the treatment in 33% and 15%, respectively, of the cases in which these decisions were made. Furthermore, although a statistically significant association was found between physicians’ global ratings of their patients’ HRQL and treatment decisions, this was not the case for the more specific HRQL domains assessed by the COOP/WONCA charts. In the presence of either tumor progression or serious treatment toxicity, HRQL considerations played little or no role in treatment decisions. More striking, however, is the finding that approximately 70% of those patients without evidence of tumor progression or toxicity, but with seriously impaired HRQL, continued to receive their treatment as planned. Thus, HRQL considerations, in and of themselves, seem to trigger changes in treatment in only a minority of cases. These results are in contrast with the findings from previous surveys^10,11 in which the majority of physicians rated the patients’ HRQL as the most important factor to be considered in making treatment decisions in the palliative treatment setting.

There are several possible explanations for the relatively modest role that HRQL issues seem to play, at least in an explicit sense, in treatment decisions surrounding palliative chemotherapy. First, cessation of active treatment runs contrary to the prevailing ethos in clinical medicine; physicians are trained to intervene, and when this is no longer feasible or appropriate, it may engender feelings of powerlessness.¹⁹

Second, physicians may decide to continue administering chemotherapy because of concern that the HRQL of their patients would deteriorate further if active treatment were to be stopped. Although the few randomized studies comparing palliative chemotherapy with best supportive care have yielded mixed findings,^20-22 they do tend to suggest that patients receiving active antitumor therapy function better emotionally than those receiving supportive care only. Slevin²³ has posited that the HRQL benefits associated with active treatment may reflect, at least in part, the provision of hope and the increased social support often experienced as a result of close medical supervision. Whether these are sufficient grounds for continuing active therapy is an ethical question that cannot be resolved empirically.

Third, patients themselves may be willing to accept even major limitations in their HRQL for relatively small survival benefits.^24-26 They may also have unrealistic expectations of the effect of treatment on survival.^27,28 For example, in a study of women with advanced ovarian cancer receiving palliative chemotherapy, 42% believed that the treatment was potentially curative, despite the fact that their physician had informed them that this was not the case.²⁸

Finally, previous research has indicated that, in general, HRQL issues play a less prominent role than is often assumed in doctor-patient communication in the palliative treatment setting. For example, we found that, in 20% to 54% of consultations in which patients experienced serious HRQL problems, no time was devoted to the discussion of those problems.²⁹ In particular, patients’ psychosocial problems and nonspecific symptoms, such as fatigue, were often left unaddressed. Patients are often unwilling to initiate such discussions themselves without some prompting from their doctor, whereas physicians report that they tend to defer to their patients in raising psychosocial health issues. In some cases, this may lead to a conspiracy of silence whereby many HRQL issues are left unaddressed because both physicians and their patients are reluctant to raise such issues without a clear signal from the other that this is appropriate and desired.³⁰

We note that these results need to be interpreted with some caution for several reasons. First, the study was conducted in a specialized cancer treatment center, and, although the patient sample was large, the number of physicians involved was limited. Although we have no reason to believe that the results are in any way atypical of what would be found in other hospitals, we encourage similar investigations in other treatment settings.

Second, the primary source of information used in this study was recorded conversations between oncologists and their patients. It is possible that, in those cases in which HRQL issues were not explicitly mentioned as a reason for modifying or discontinuing chemotherapy, they may have been taken into account in an implicit, unspoken manner. However, we believe that it is appropriate that factors contributing significantly to treatment decisions be discussed openly to ensure that the decision-making process is as transparent as possible to both patients and physicians.

Third, although consistent rules were applied to distinguish between treatment toxicity (ie, objective signs) and HRQL (ie, subjective symptoms), we recognize that they may, in some cases, be correlated. For example, chemotherapy may be discontinued if there is evidence of moderate renal failure, even though the patient may not yet be experiencing symptoms. If the treatment were to be continued, however, the patient would become symptomatic. In such a case, the explicit reason given for treatment cessation—abnormal renal function—may reflect an underlying but implicit concern with the future HRQL of the patient. Again, however, we would argue that, in such cases, the implications of objective indicators of toxicity for the functioning and well-being of the patient need to be made explicit.

In conclusion, although physician surveys have indicated that HRQL considerations play a prominent role in the decision to modify or stop palliative cancer treatment, the results of this study, based on actual patient-physician encounters, suggest that this is so in only the minority of cases. Not surprisingly, tumor progression and serious treatment toxicity virtually always result in treatment modification or cessation. However, in the absence of these traditional, objective indicators of treatment failure, the patient’s HRQL, even when seriously compromised, often does not trigger a change in treatment. With the increased interest in oncology in patient-reported outcomes and patient-centered treatment, additional efforts should be directed toward incorporating HRQL factors, both formally and informally, in patient-physician communication and in clinical decision-making.

	ACKNOWLEDGMENTS

 
Supported by grant no. NKI 95-1134 from the Dutch Cancer Society.

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Submitted April 12, 2001; accepted October 29, 2001.

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