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© 2002 American Society for Clinical Oncology Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy–Hepatobiliary QuestionnaireByFrom the Hepatobiliary Disease Management Program, Memorial Sloan-Kettering Cancer Center, and Beth Israel Medical Center, New York, and Jacobi Medical Center, Bronx, NY; Evanston Northwestern Healthcare and Northwestern University, Evanston, IL; and Community Cancer Care, Indianapolis, IN. Address reprint requests to Nancy Heffernan, RN, BSN, Hepatobiliary Disease Management Program, Memorial Sloan-Kettering Cancer Center, Hepatobiliary Service Box 549, New York, NY 10021; email: heffernn{at}mskcc.org
PURPOSE: This is the first report on the development and initial validation of the Functional Assessment of Cancer Therapy–Hepatobiliary (FACT-Hep) questionnaire, a 45-item self-report instrument designed to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers. The FACT-Hep consists of the 27-item FACT-G, which assesses generic HRQL concerns, and the newly validated 18-item Hepatobiliary Subscale (HS), which assesses disease-specific issues. PATIENTS AND METHODS: The development of the HS followed a four-phase process of item generation, item reduction, scale construction, and reliability/validity testing. Two independent samples were studied: item generation (sample 1; n = 30) and reliability/validity testing (sample 2; n = 51). RESULTS: In sample 2, all subscales and aggregated scores showed high internal consistency at initial assessment (Cronbach’s alpha range, 0.72 to 0.94) and retesting (Cronbach’s alpha range, 0.81 to 0.94). Measurement stability over a 3- to 7-day period was also high for all aggregated scales (test-retest correlation range, 0.84 to 0.91; intraclass correlation coefficient range, 0.82 to 0.90). Convergent and divergent validity were demonstrated by examining relationships between FACT subscales and mood, social support, and social desirability. Finally, when performance status and treatment status were used to divide sample 2, the HS differentiated groups to a degree comparable to the Physical and Functional Well-Being subscales of the FACT-G, thereby contributing favorably to a 32-item Trial Outcome Index. In addition to the 18 validated, scored items in the HS, seven treatment-related items may be appended, if clinically indicated, as a separate subscale. CONCLUSION: The 45-item FACT-Hep can be used independently as a brief measure of disease-related symptoms and functioning. Alone or paired with the FACT-G, the HS has promise for use in assessing the disease-specific HRQL of patients with hepatobiliary cancers.
HEPATOBILIARY CANCERS, including pancreatic cancer, cholangiocarcinoma, gallbladder cancer, and primary and metastatic cancers of the liver, historically have been associated with a poor prognosis and poor health-related quality of life (HRQL). However, recent advances in hepatic surgical techniques along with improved patient selection have resulted in hepatic resection being considered safe and effective therapy for hepatocellular carcinoma, hilar cholangiocarcinoma, and metastatic colorectal cancer.1-4 For patients with disease that is not amenable to potentially curative resection, current palliative interventions including ablative therapies and new chemotherapeutic agents have modestly but significantly improved survival and HRQL.3,5-8 For example, the introduction of irinotecan, given alone or in combination with hepatic arterial infusion chemotherapy for patients with advanced metastatic colorectal cancer, has resulted in improved response and survival rates.7,9,10 The administration of gemcitabine for locally advanced or metastatic pancreatic cancer has been shown to have clinical benefits and has in fact improved survival in randomized studies.6,8,11 Whether the patient is benefiting from potentially curative therapy or is being treated in palliative care settings, interest in formally measuring HRQL of patients with hepatobiliary cancers has been on the rise. This is particularly true for patients who are receiving palliative care due to the symptomatic burden that they carry and the desire to realize some measurable benefit in the face of increasing treatment intensity. HRQL concerns for patients with hepatobiliary cancer include physical symptoms and psychological issues, many of which are common to cancer patients in general and some unique to their disease.12-14 Jaundice resulting from malignant biliary obstruction is one of the most troubling problems. Symptoms associated with obstructive jaundice include malaise, itching, and dehydration.15,16 Gastrointestinal symptoms include indigestion, early satiety, and anorexia leading to weight loss. Furthermore, the pronounced energy depletion and muscle wasting from advanced hepatobiliary cancers can result in severe weakness, fatigue, and depression.17 Palliation for biliopancreatic malignancy focuses on relief of symptoms such as obstructive jaundice, bowel obstruction, and pain.6,18-20 Assessing the impact of potentially curative and palliative interventions on the HRQL of patients with hepatobiliary cancer is a vital component of contemporary clinical trials in this patient group and may become an important component of clinical care that may enable patients and their providers to make informed decisions regarding treatment.
Outcome measurement in oncology historically has been limited to survival and treatment toxicity.21 However, it is now widely accepted by clinicians and patients that quality of survival is as important as length of survival and that HRQL is an important clinical end point. The available literature on HRQL in hepatobiliary cancers is limited, and no gold standard exists for measuring HRQL in patients with these diseases. This has resulted in a paucity of data on the HRQL of even those patients who are receiving interventions aimed at improving HRQL. For example, palliating the effects of biliary obstruction is a primary goal of therapy for patients with hilar biliary obstruction, yet few studies have adequately addressed quality of survival beyond reporting treatment morbidity. This is unfortunate because the majority of patients have incurable disease and palliation is a major goal.19,22 Results of a study comparing surgical resection to palliative surgical bypass in patients with hilar bile duct cancer revealed that patients whose tumor was resected had a much better quality of life compared with patients who received palliative bypass. Postoperative quality of life was assessed in terms of level of function, presence of symptoms, and need for hospitalization. A formal quality-of-life measure, however, was not used in this study.15 Patients who had pancreatic cancer and underwent pancreaticoduodenectomy had near-normal HRQL scores in one large single-institution study.23 Both hepatic arterial embolization and surgical resection provide excellent palliation of hormonal and pain symptoms for metastatic neuroendocrine tumors in the liver.24 HRQL research in oncology has grown tremendously in the past two decades as evidenced by the development of HRQL instruments. Scales for pancreatic cancer and other gastrointestinal diseases have been published recently. For example, Ward et al25 reported a validated colon cancer subscale for the Functional Assessment of Cancer Therapy (FACT) measurement system. Its use is restricted to patients with colon cancer. This subscale led to the development of a pancreatic cancer-specific subscale for the FACT, which, although used in trials, was never published. The European Organization for the Research and Treatment of Cancer (EORTC) QLQ-PAN 2626 is a 26-item pancreatic cancer–specific instrument. Its use is restricted to pancreatic cancer and available only when using the 30-item EORTC core questionnaire, resulting in a lengthy (56-question) assessment. The Gastrointestinal Quality of Life Index demonstrated good internal consistency and construct validity when used in a sample of patients with potentially operable periampullary carcinoma.21 It has not been tested, however, on patients with liver cancer. Cancer of the liver, particularly hepatocellular carcinoma and metastatic colorectal cancer, are not uncommon worldwide, yet there is no relatively concise instrument to capture a sufficient range of disease-specific HRQL issues in these and other hepatobiliary cancers, including those of the gallbladder and biliary tract. Patient outcomes including quality of life should be a priority for cancer treatment guideline development. The development of valid, reliable HRQL instruments is an essential part of quantifying the physical, social, and psychological distress associated with cancer and its treatment. HRQL instruments should have several components, including self-report style, multiple dimensions, developed from patient-generated information, low respondent burden, and ability to obtain subscale scores and an overall HRQL score.27-29 The FACT, part of the larger FACIT (Functional Assessment of Chronic Illness Therapy) Measurement System is a compilation of disease-, treatment-, and condition-specific questionnaires that meet all of the standards for HRQL assessment.25,30 The purpose of the present study was to develop and validate a subscale for measurement of hepatobiliary disease–specific HRQL issues, using the FACT-General (FACT-G) as a starting point.
The FACT-G (version 3) is a 27-item self-report instrument that assesses four dimensions of HRQL: physical, social/family, emotional, and functional well-being. These 27 general questions are applicable to patients with all types of cancer and have been used with other chronic conditions (eg, HIV/AIDS, multiple sclerosis). Additional disease-, treatment-, and condition-specific subscales have also been developed to assess symptoms or issues specific to a particular illness, treatment, or condition.14,25,30,31 The development and validation of the general component of the FACT-G took place from October 1987 through February 1992. Through ongoing validation studies, the FACT-G has demonstrated sound psychometric properties to support its usefulness in evaluating HRQL in cancer populations.25,27,32 The FACT has been used internationally and is currently available in more than 40 languages. It is targeted at the sixth-grade English reading level and has tested as low as the third-grade level.33 It requires less than 10 minutes to complete. Respondents use a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). The FACT-G consists of four HRQL dimensions: physical well-being (seven items), social/family well-being (seven items), emotional well-being (six items), and functional well-being (seven items). When a disease-specific subscale is used, five subscale scores and an overall HRQL score can be calculated, with higher scores reflecting better HRQL. The FACT-G has demonstrated both discriminant and convergent validity, with test-retest correlations ranging from 0.82 to 0.92 for each FACT-G subscale. A summary index of physical/functional outcomes can also be calculated using the Trial Outcome Index (TOI; sum of the physical, functional, and disease-specific concerns).
Study Design From June 1997 through April 1998, development and validation of the FACT Hepatobiliary Subscale (HS) occurred in four phases: item generation, item reduction, scale construction, and validity and reliability testing. This process yielded a set of 18 HRQL concerns specific to hepatobiliary cancers that was then added as a site-specific subscale to the FACT-G. The combined scales became the FACT-Hepatobiliary (FACT-Hep). On the basis of the standard methodology developed by Cella et al,31 81 patients were accrued for the development and initial testing of the FACT-Hep. Thirty patients were interviewed for the item generation phase, and 51 patients were interviewed for validity testing. Inclusion criteria of the study samples were (1) 18 years of age or older; (2) diagnosis of cancer of the liver (primary or metastatic), pancreas, gallbladder, or bile duct; and (3) ability to speak, read, and write English. An attempt was made to enroll patients who were representative of the institution’s hepatobiliary database in terms of age, sex, race, and cancer diagnosis. Exclusion criteria included (1) evidence of cognitive impairment or psychiatric disturbance that would prevent the patient from giving informed consent or (2) physical condition that would render 30 to 50 minutes of testing too physically demanding. Approval to conduct this study was granted from the hospital’s institutional review board. Patients for both the interview and the testing phases were recruited from the outpatient clinics of several surgical and medical oncologists at an NCI-designated comprehensive cancer center. Eligible patients signed informed consent. Interviews and administration of questionnaires were done by two of the authors (N.H. and M.M.).
Procedure Phase II: Item reduction. After 17 redundant questions were removed from the responses of both patients and professionals, 43 items remained. Three independent judges, also hepatobiliary expert clinicians, were asked to review the 43 items. They rated each item independently for overlap with existing (FACT-G) items, clarity in wording, and relevance to HRQL for patients with hepatobiliary cancer (on a scale of 0 [not at all relevant] to 4 [very relevant]). The judges eliminated overlapping, unclear, or low-relevance items and determined the final set of items to be included in the HS. This final set of 30 items was reviewed and endorsed for patient testing by the original six hepatobiliary experts. Phase III: Scale construction. The same five-point Likert-type intensity rating scale used by the FACT-G was used for the 30 HS items. This was done to minimize inconvenience and cognitive burden for the respondent. Questions were formatted using the same layout used in the FACT-G. Phase IV: Initial reliability and validity testing. The newly constructed HS underwent initial psychometric evaluation to obtain validity and reliability data in a second sample of patients with hepatobiliary cancer. This group of patients was shown the same ECOG PSR scale as the group in phase I and asked to assign themselves to one of five groups. ECOG PSR (patient-rated), sociodemographic data, clinical information, and treatment histories were recorded. A battery of measures were administered to evaluate convergent and divergent validity. This included the Profile of Mood States–Short Form (POMS-SF),35 the Interpersonal Support Evaluation List (ISEL),36 and the Marlowe-Crowne Social Desirability Scale.37 The 27-item FACT-G and selected items from the Pancreas, Colon, and Fatigue subscales25,27,38 totalling 42 items from existing FACT subscales were administered. The items selected from the FACT Pancreas, Colon, and Fatigue subscales were added because they bore close resemblance to the issues raised in phase I and it was thought most efficient to draw from existing questions whenever possible. Fifteen new FACT-Hep items were appended to the questions selected from the Pancreas, Colon, and Fatigue subscales. This combined list of 30 items was titled "Additional Concerns" for administration. To assess instrument stability (test-retest reliability), we asked patients to complete a retest of the FACT-Hep at home within 3 to 7 days of their baseline assessment. Addressed, stamped envelopes were provided, and the investigators telephoned the patients to remind them to complete and return the retest packet. Of the 59 patients who were approached to participate in the testing of the newly developed HS, five refused, giving reasons such as fatigue, concern about signing a consent form, and lack of interest. One patient was removed from the study after discovery of a significant psychiatric history. Of the 54 eligible, consented patients, 51 (94%; 86% overall response rate) completed the battery of questionnaires for determination of convergent and divergent validity. Baseline questionnaires were completed in the outpatient clinic and the retest at home 3 to 7 days later.
Demographic characteristics of both the item generation sample (sample 1) and the validation sample (sample 2) are shown in Table 1. Both samples were representative of the population of the study institution. There were slightly more women than men in the item generation sample. For both samples, the average age was middle 60s and the majority were well educated with 12 years of education or more and were predominantly white non-Hispanic and married.
Clinical characteristics of both samples are shown in Table 2. The greatest number of patients in both samples had liver disease, either primary liver cancer or metastatic from the colon. The diagnoses of patients listed as "other" consisted of ampullary, neuroendocrine, and distal bile duct cancer. Disease status differed between samples. In sample 1, 67% had some evidence of disease as opposed to 43% of patients in sample 2. History of current therapy also differed between the two samples. Current therapy was defined as either ongoing or completed within the past 4 weeks. Most patients in sample 1 (63%) were not receiving therapy currently, whereas 65% of patients in sample 2 were receiving current therapy. There was a sizable proportion of patients with a PSR of 2 or greater in both sample 1 (44%) and sample 2 (45%).
FACT-G subscale and total scores were calculated according to the scoring methodology referenced in the FACT manual (version 3).31 Standard statistical methods were used to examine the HS for internal consistency, including an iterative deletion of "misfitting" items, to create the most reliable, robust set of items. Deletion of misfitting and excessively redundant questions produced a subscale of 19 (of the original 30) items composing the HS for additional testing. Internal consistency (coefficient alpha [  ]) and stability (test-retest reliability) coefficients were computed. To test criterion-related validity, we matched clinical characteristics (ie, performance status) to HS and FACT-G scores. Content review of the final 19 items confirmed that all items related to symptoms or problems associated with hepatobiliary cancer. The reduced, 19-item HS includes 18 items that are currently scored. The remaining question ("I am bothered by swelling in my legs") did not correlate with the other 18 but has been retained for clinical relevance. An additional seven treatment-related concerns may be appended if clinically indicated as a separate subscale but are not currently scored. These questions refer to biliary drainage catheters and hepatic arterial infusion pumps and may be appended at the user’s discretion. The HS, with the treatment-related items, is shown as Appendix 1.
Table 3 presents descriptive statistics for the FACT-Hep subscales, total score, and TOI. All subscales and aggregated scores showed high internal consistency at initial assessment (Cronbach’s alpha [
Convergent-Divergent Validity Spearman’s  correlation coefficients assessed the strength of relationships between the FACT subscales, HS, and the TOI (Table 4). Correlations with the POMS total score were particularly strong, exceeding -0.70 for FACT Functional, HS, TOI, and total scores. The POMS scale correlation with the 45-item FACT-Hep was unusually high (r = -0.86), suggesting a strikingly close association of disease-specific HRQL and patient mood in this population. Not surprising, the social support questionnaire (Interpersonal Support Evaluation List) subscales and total score correlated significantly only with the social well-being subscale (r = 0.28). The Marlowe-Crowne social desirability scale was included to demonstrate divergent validity (ie, no relationship should exist between social desirability and self-reported quality of life). Indeed, there was little evidence of a measurable relationship, with the highest magnitude coefficient (0.20) seen in emotional well-being. None of the coefficients was statistically significant.
PSR To examine the expected relationship between performance status and HRQL, we performed a number of generalized linear models for subscale and scale scores. Results for the validation sample are summarized in Table 5 and Fig 1. The patients were divided into three performance status groups: 0, normal functioning, without symptoms; 1, some symptoms but no extra rest required; and 2 to 3, some degree of bed rest needed during the waking day. All FACT-G subscales except the SWB showed differences in means on the basis of performance status, with the highest mean score associated with the best self-reported health. Of note, the 18-item HS was successful in discriminating these three groups. Post hoc comparisons of groups (Tukey test) indicated that this new subscale differentiated each of these three groups from one another (see Fig 1).
On- or Off-Treatment Comparisons Patients were divided into treatment groups to examine differences in HRQL. On treatment was defined as ongoing or having received treatment in the past 4 weeks. The types of treatment included abdominal surgery, chemotherapy, radiation therapy, ablative therapy (hepatic arterial embolization and alcohol injections to the liver), and biliary stent placement. Because symptomatic disease is often a cause for intervention and because interventions themselves are associated with toxicity and short-term disability, the HRQL of patients on treatment can be expected to be worse than that of patients off treatment. Table 5 and Fig 2 demonstrate the degree of sensitivity of the FACT-Hep subscales and aggregated scores to this differentiation of patients. The FACT Physical Well-Being (PWB), FWB, and Hepatobiliary subscales differentiated patients on treatment from those off treatment. As a result, the TOI, a composite of these correlated subscales, was also worse (lower) for patients on therapy.
Cancers of hepatobiliary origin along with metastatic cancers to the liver unfortunately are common. Also unfortunate is that almost 85% of patients with biliopancreatic malignancy are not candidates for curative resection and will need palliative treatment.40 Obstructive jaundice is common and often recurrent and can be accompanied by anorexia, weight loss, fatigue, and pain. For patients with unresectable gallbladder, bile duct, and pancreatic cancer, optimal palliation of obstructive jaundice is a matter of ongoing debate. It has been suggested that for patients with more advanced disease and expected survival of less than 3 months, optimal treatment is nonsurgical (endoscopic or percutaneous biliary stent placement). For patients with a longer predicted life expectancy, surgical bypass offers better palliation with fewer hospital admissions for stent exchange.18-20,41 Optimal palliation of patients with limited life expectancy is crucial because symptoms of progressive hepatobiliary disease are often unbearable.40 For this group of patients in particular, who will not be cured of their disease, quality of life is the natural yet seldom measured outcome. Outside of clinical trials, assessment of HRQL has been overlooked in this patient population. Assessment of disease-related HRQL concerns has been lacking, in part because of the deficiency of valid, reliable instruments. Organizing these and other concerns into one disease-specific set of questions can fill a need in treatment outcome evaluation of these patients. The goal of this study was to develop a quality-of-life instrument that accurately assesses hepatobiliary cancer–specific issues, and the resulting FACT-Hep questionnaire may be put forth as a reliable and valid instrument for this purpose. This study has shown that the 45-item FACT-Hep questionnaire has very high internal consistency, has excellent test-retest reliability, and shows preliminary evidence of convergent and divergent validity. It has been found to separate successfully groups of patients on the basis of self-reported ECOG performance status and treatment status. Patients with lower ECOG PSR numerically performed better on this measure than did patients with higher ECOG PSR, as would be expected, as a low ECOG score indicates better health. The FACT-Hep (in particular the PWB, FWB, and HS) also separated groups of patients on the basis of treatment status, with patients on treatment demonstrating lower HRQL scores. With the exception of the SWB subscale, the FACT-Hep and its subscales were highly correlated with the POMS total score (r range, -0.65 to -0.88). This close association may be attributable to the fact that patients with intra-abdominal cancers have higher rates of depression than patients with other cancers.12,42 Patients with pancreatic cancer are particularly prone to depression, and this relationship is not solely tied to poor prognosis.13,43 Hormonal and other neuropsychiatric explanations of depression in these patients have been offered.43 There is overlap in some depressive signs and symptoms and the signs and symptoms of all cancers but especially in hepatobiliary cancers (eg, fatigue, anorexia, weight loss, and so on12). We therefore further examined the association between POMS subscales and the FACT-Hep to understand this relationship better (Table 4). We specifically noted the patterns of relationship between the POMS subscales of Tension, Depression, Fatigue, and Vigor with the FACT-Hep subscales. The POMS Tension and Depression were considerably correlated with FACT Emotional Well-Being and, secondarily, with Functional Well-Being. However, Fatigue and Vigor on the POMS were highly related to Physical and Functional Well-Being. The pattern of associations of the HS symptoms with the POMS subscales resembles that seen for Physical/Functional Well-Being. Specifically, POMS Fatigue and Vigor have a stronger relationship to hepatobiliary symptoms than POMS Depression and Tension. So, although there is certainly a higher degree of association between hepatobiliary cancer symptoms and mood, the magnitude of the association seems to be related at least as much to fatigue as to depression or tension. Many clinical trials are in progress to improve the survival for hepatobiliary cancers. Much of what is reported in the literature regarding HRQL of patients with hepatobiliary cancer focuses on morbidity, mortality, and treatment toxicity. Quality-of-life assessment in cancer patients has been reserved primarily for use in clinical trials. There is, however, a pressing need for the development of quality-of-life measures for use in clinical practice.44 At the start of this project, there was no valid and reliable HRQL instrument available for assessment of disease-specific symptoms and concerns of patients with the range of hepatobiliary cancers studied here. The FACT-Colon and the FACT-Pancreas included many of the important concerns but limit the population of patients eligible to use the questionnaire. Pretesting for the EORTC-QLQ-PAN26 has been completed, and a full validation study is under way.26,45 It is a promising instrument but geared only to pancreatic cancer. Now that there are assessment options for patients with hepatobiliary cancers, it may be useful to compare them in future studies. For example, when studying patients with colon cancer and liver metastasis, one could choose the 27-item FACT-G plus the nine-item colon cancer subscale, six items of which are in the HS reported here. Alternatively, one could choose to use the 18-item HS. In the absence of data directly comparing these two options with regard to reliability, precision, and sensitivity, the choice at this point is best made by a review of the questions in each subscale in relation to one’s assessment purpose. A significant consideration in this very ill patient population is the relatively high risk of attrition in longitudinal studies as a result of death and disability. In the latter case, missing data rates rise with increasing burden of assessment. Thus, one must weigh the comprehensiveness and (usually) increased reliability of longer assessment against the higher data completion rates of shorter assessment. Efforts to obtain data by interview, and flexibility of timing can help completion rates. Scoring rules for prorating scores when some of the questions are answered are also available.30 Finally, a much-shortened eight-item symptom index has recently been created from this longer, more detailed 45-item questionnaire.46 This can be used in settings such as clinical trials or longitudinal cohort studies in which grouped data on symptoms only might be of interest. In conclusion, the FACT-Hep questionnaire performs at an excellent level in assessing quality of life for patients with hepatobiliary cancers, including metastatic colorectal cancer, hepatocellular carcinoma, pancreatic cancer, and cancers of the gallbladder and bile duct. It exceeds acceptability in terms of reliability and validity of measurement. The HS itself is psychometrically sound and should prove useful to clinicians and researchers as an independent, concise assessment of concerns related to hepatobiliary cancers. This self-report questionnaire is appropriate for administration to patients with hepatobiliary cancer at various stages in the disease process and has shown demonstrable reliability and validity in assessing patients’ physical and functional status. An important next step is to test the FACT-Hep in clinical trials and clinical practice to evaluate its responsiveness to important changes in HRQL.
APPENDIX 1:
APPENDIX 2 Appendix 2 listing the FACT-G and FACT-Hep scoring guidelines is available online at www.jco.org. 
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Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
0.70 generally regarded as acceptably high for aggregation of responses into a single score.
