Gynecologic Oncology Group (GOG).
Explore the source record for details and available documents.
Clinical Trials, Phase III as Topic↗
Biomedical subjects
D F Cella
Publications and source records attributed to D F Cella.
Quality of life outcomes: measurement and validation.
New treatments for cancer often are evaluated solely on the basis of increased survival, and thus, lack valuable information about other benefits and drawbacks of these treatments. It is important to raise the issue of the quality of life as a companion to the issue of quantity of life. The trade-off is not always between toxicity and survival time; sometimes a treatment, however toxic, affords benefit not by virtue of increasing survival, but rather, by palliating tumor-induced pain or obstruction. Proper selection of measures and supplementary questions is an important first step toward a successful evaluation of QOL. Included in this article is a table that reviews many available QOL measures that have been designed for, or are frequently used with, people with cancer. One cancer-specific questionnaire, the Functional Assessment of Cancer Therapy (FACT), also is reproduced.
Humans↗
The Functional Assessment of Cancer Therapy (FACT) scale. Development of a brain subscale and revalidation of the general version (FACT-G) in patients with primary brain tumors.
BACKGROUND: This report describes the development and validation of a brain subscale for the Functional Assessment of Cancer Therapy (FACT) scale, and the revalidation of the subscales of the general version (FACT-G), which measure physical, social, family, emotional, and functional well-being and the quality of the relationship with the physician. METHODS: 101 patients with primary brain tumors, after giving informed consent, participated in the last two phases of a four-phase validation process: item generation, item reduction, validation, and reliability testing. In the validation phase, FACT-G subscale and total scores as well as the brain subscale scores were correlated with other tests of mood, response, bias, and quality of life (QOL). Test-retest reliability testing was performed with 46 patients who had primary brain tumors. RESULTS: Validity and reliability coefficients were high for the FACT-G and brain subscale, except for the comparison with a second QOL measure (FP-QLI) and the Karnofsky Performance Status (KPS). The lower scores were the result of inherent differences in the two QOL instruments and the relatively high performance status of the brain tumor patients, which restricted the KPS score range. CONCLUSION: The FACT-G has good psychometric properties supporting its broad generalizability and the brain subscale tests substantially different QOL issues than the core instrument. Use of this scale with the addition of the brain subscale provides a well rounded view of the various aspects of QOL from the patient's perspective. With modifications and further psychometric testing, the brain subscale may have broader applicability to subpopulations of patients with other brain disorders.
Adult↗
Methods and problems in measuring quality of life.
The US health-care transition demands increased accountability for medical care. This has contributed to increased interest in documenting valued medical outcomes, including improvements in health-related quality of life and treatment satisfaction. These data can only be obtained validly by asking patients directly about their current health state, perception of well-being, and satisfaction with care. A core set of well-validated instruments have been developed to measure health-related quality of life in patients with cancer. As these are employed with increasing frequency, rigorous quality assurance of data collection is critical. Because of the necessity of quality control, patient-reported data collection can be labor-intensive and prohibitively costly. However, time and cost-saving methods, such as centralized telephone survey methods or on-site direct data entry via interactive computer, can guarantee high-quality data while minimizing costs. Justification of the need for these methods and a brief description are provided.
Data Interpretation, Statistical↗
The Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI): a brief assessment of patients' subjective response to treatment for anorexia/cachexia.
A brief visual analogue instrument was developed and tested in the context of a multicentre randomized double-blinded four-dose trial of megestrol acetate for the treatment of AIDS-related anorexia/cachexia. This nine-item instrument, the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI), was administered every 4 weeks after initiation of study drug (placebo vs 100 mg, 400 mg or 800 mg of drug). The purpose of the instrument was to quantify patient perception of benefit in areas such as decreased concern over weight, decreased concern over appearance, increased pleasure in eating and increase in global perception of quality of life. Post-trial psychometric evaluation of the instrument strongly supported the use of a seven-item index of subjective recovery from symptoms of anorexia/cachexia (BACRI-7) and a single criterion item depicting patient perception of benefit (BACRI-1). The BACRI-7 and BACRI-1 scales showed significant improvement over 12 weeks in patients who received higher dose active drug (400 and 800 mg) compared with the placebo and 100 mg doses. Further differentiation of 400 vs 800 mg arms was seen in the BACRI-7 results, consistent with dose-response improvements in weight and lean body mass changes. Quadratic trends over time in lean body mass change and provider-rated appetite grade suggested peak therapeutic effect at 8 weeks for these endpoints, whereas the absence of these trends in overall weight and patient-reported BACRI scores suggested that these benefits are more persistent. Although subjective (patient-reported) benefit is strongly associated with objective indicators of improvement, there remains the possibility that there is some added, independent benefit of megestrol acetate to subjective well-being.
Acquired Immunodeficiency Syndrome↗
Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument.
The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.
Adult↗
Correlates of stress in HIV disease.
A group of 53 men with HIV disease participated in this correlational study of the relationships among psychological distress, quality of life, uncertainty, coping patterns, stress, and CD4+ T-lymphocyte levels. Meaningful correlations (r > .40, p < .01) indicated that higher levels of negative-impact stressful experiences were associated with more frequent use of emotion-focused coping; both higher levels of negative stress and more frequent use of emotion-focused coping were associated with lower quality of life, higher psychological distress, and more uncertainty; lower quality of life was associated with higher psychological distress and more uncertainty; and lower CD4+ counts were associated with higher levels of positive-impact stressful experiences.
Adaptation, Psychological↗
Someone to live for: social well-being, parenthood status, and decision-making in oncology.
PURPOSE: Little is known about the influence of social factors on treatment preferences and desire for aggressive cancer therapy. The present study assessed subjective and objective social indicators in patient preferences for treatment. METHODS: Cancer patients (N = 296) with diverse diagnoses and stages read sets of hypothetical vignettes describing patients with early-stage and advanced disease. In the first set, patients made decisions about treatment acceptance given varying levels of either increasing cure or extending survival. In the second set, the point at which patients shifted preferences from mild to severe treatment to improve likelihood of 1-year survival (switch point) was the dependent measure. We assessed the impact of quality-of-life (QL) domains measured by the Functional Assessment of Cancer Therapy-General (FACT-G), having children, marital status, and living arrangements on treatment preferences and switch points. RESULTS: The Social Well-Being (SWB) subscale of the FACT-G predicted both treatment acceptance (P = .007) and switch point (P = .043) in the advanced-disease vignettes, with lower SWB associated with less aggressive preferences. Children living at home was likewise associated with more aggressive intent both in treatment preferences (P = .003, advanced-disease vignette) and switch point (P < .001 and P = .001 for early- and advanced-disease vignettes, respectively). Living with others predicted more aggressive intent in the advanced-disease vignette (P = .03). Marital status did not predict either treatment acceptance or switch point. CONCLUSION: Positive social well-being, as well as having children living at home, predicted patient willingness to accept aggressive treatment. Willingness to receive aggressive treatment may explain or mediate previously reported salutory effects of social support on cancer outcomes.
Adaptation, Psychological↗
Measuring quality of life in palliative care.
In the palliative treatment of chronic illness, attention must extend beyond symptom control to include the overall quality of patients' lives. Symptom relief is highly valued by patients and usually is associated with improvement in general functioning and well-being (ie, overall quality of life). Side effects and costs of therapy, however, also must be included in the equation to fully balance the treatment decision. Patients tend not to think dichotomously in terms of toxicity versus efficacy; rather, they consider the aggregate of their capabilities, circumstances, and somatic sensations. In fact, they often confuse symptoms with side effects. We must therefore survey patients in terms of their disaggregated experience, using a valid self-report questionnaire, and help them make decisions about treatment by estimating which deficiencies or improvements are attributable to disease versus treatment. The dialogue that this demands is challenging, because it can threaten the adaptive suppression that many patients use to protect themselves from negative feelings. Unfortunately, the consequence of avoiding this dialogue often is unnecessary treatment given with misunderstood intentions.
Cost of Illness↗
Measuring quality of life: 1995 update.
Often, new treatments for cancer are evaluated solely on the basis of increased survival, depriving us of valuable information about other benefits and drawbacks of these treatments. It is important to raise the question of the quality of life as a companion to the question of quantity of life. The trade-off is not always between toxicity vs survival time; sometimes a treatment, however toxic, affords benefit not by virtue of increasing survival, but by palliation of tumor-induced pain or obstruction. Included in this paper is a table that reviews many available quality of life measures that have been designed for, or frequently used with, people with cancer. Proper selection of measures and supplementary questions is an important first step toward a successful evaluation of quality of life. Samples of many of these scales are included in the appendix.
Humans↗
Age and clinical decision making in oncology patients.
BACKGROUND: Ageism is a cultural bias that might inappropriately steer oncologists away from recommending aggressive treatments for older patients. The extent to which older patients might prefer less aggressive cancer therapies is unknown. Our lack of knowledge about patients' personal preferences for therapy may perpetuate this bias. PURPOSE: We conducted a study to determine 1) if age influences patient acceptance of cancer therapy and 2) if the older patients would be more or less likely to trade increased survival for maintaining quality of life than their younger counterparts. METHODS: Using an interview format, 244 cancer patients of all ages treated at a tertiary care cancer center read two sets of hypothetical vignettes. The first set consisted of four vignettes that varied in terms of stage of disease and treatment toxicity. Patients were asked to make hypothetical decisions about treatment given with respect to varying levels of either increasing cure or extending survival. The second set of vignettes presumed acceptance of cancer therapy. Within each vignette, two hypothetical treatments (mild versus severe) with different probabilities of 1-year survival were contrasted. The point at which patients shifted preferences from a treatment with mild versus severe side effects was the dependent measure. Mixed analysis of variance (ANOVA) procedures (F test) assessed the impact of age (< 65 years versus > or = 65 years) and patient disease stage (early versus advanced) on hypothetical decisions about treatment. All P values are two sided. RESULTS: In the treatment-preference vignettes, there was no effect of either age [F(1,239) = 2.14; P = .14] or patient stage [F(1,239) = .40; P = .53] on treatment acceptance. Older adults were as likely as their younger counterparts to agree to chemotherapy for both curative and control purposes. In the switch-point vignettes, younger adults switched to a more toxic treatment to gain survival advantage at an earlier point than the older patients in both the early-disease vignette [F(1,232) = 3.88; P = .05] and the advanced-disease vignette [F(1,232) = 4.43; P = .036]. There was neither an effect of disease stage on treatment decisions nor an interaction between disease stage and age. CONCLUSIONS AND IMPLICATIONS: In a tertiary care setting, older adults do not differ from their younger counterparts in terms of acceptance of chemotherapy. However, when treatment is presumed, they differ in terms of willingness to trade survival for current quality of life. Generalization of findings is limited by the relatively small sample of older adults (n = 43) and the referral population from which the sample was drawn. Replication with a larger older adult sample in a community setting is needed.
Adult↗
Quality of life: concepts and definition.
After years of second-class status, supportive care is increasingly being recognized for its importance. Included in this recognition is a concern for making more explicit the long-held conviction within medicine that no goal can logically be more important than optimal patient functioning and well-being. This effort to make more explicit the timeless value of medical care has evolved over the past two decades, and come to be labeled "quality of life" research. At its most fundamental level, quality of life is understood to be both subjective and multidimensional. Because it is subjective, it is best measured from the patient's perspective. Because it is multidimensional, its measurement requires the investigator to inquire about a range of areas of the patient's life, including physical well-being, functional ability, emotional well-being, and social well-being. The usual concern for symptom control, familiar to the palliative-care physician, can conceptually be expanded into a consideration of costs and benefits of various treatment options relative to their subjective perception of personal function and well-being. As our interest turns to the aggressive alleviation of specific ("target") symptoms, we must critically evaluate the complex relationships among symptom intensity, symptom duration, and overall quality of life.
Humans↗
Data collection strategies for patient-reported information.
The U.S. health care transition demands increased accountability for medical care. This has contributed to increased interest in documenting medical outcomes, including improvements in health-related quality of life and treatment satisfaction. These data can only be obtained by asking patients directly about their current health state, perception of well-being, and satisfaction with care. Systematic collection of patient-reported data is often poorly done because its demands are underestimated and inadequately supported. Rigorous quality assurance is critical in any clinical trial or treatment delivery evaluation program.
Clinical Trials as Topic↗
Integrating health-related quality of life into cross-national clinical trials.
When planning to implement health-related quality of life (HRQL) assessment in a multinational clinical trial, there are at least four general considerations: the natural history of the disease or condition, the characteristics of the population, the treatment under consideration, and the structure and function of the clinical trial organization. Each of these considerations must be addressed simultaneously when planning, implementing and analysing a cross-national clinical trial. There are five relevant polar components of the natural history of a given disease or condition: (1) time frame (acute versus chronic); (2) life threat (yes versus no); (3) symptomatology (present versus absent); (4) symptom expression (episodic versus constant); and (5) functional impact (present versus absent). Differences in population characteristics, (e.g., age, conditions, co-morbidity), embedded within any cross-national trial, must be addressed conceptually prior to initiating the trial, methodologically when planning implementation, and statistically after the collection of the data. In terms of treatment, issues such as adverse and positive effects and timing of effects must be considered. The methods entailed in planning, implementing and analysing HRQL data will depend upon the degree of centralization of personnel and resources within any given clinical trial. The range of possibilities runs from complete centralization, in which all planning and coordination of data collection and transmittal is done by one office, to complete decentralization, in which the work is distributed to participating sites and interested investigators. Finally, successful implementation of HRQL data collection is enhanced by heightening awareness of the importance of, and value in, assessing HRQL in clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS)
Cross-Cultural Comparison↗
The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.
PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.
Adult↗
Quality of life in cancer: definition, purpose, and method of measurement.
Over the past 20 years, changes within medicine and society have encouraged an expansion in conceptualizing and evaluating the goals and important outcomes of medical treatments. In evaluating the care of people with cancer and other chronic illnesses, a major part of the expansion has been the inclusion of means to assess the quality of life in addition to the quantity of life associated with various treatments. This paper presents a review of the current literature on quality-of-life assessment in oncology research and practice. The review is organized around current thinking about the definition of quality of life, the purpose of quality-of-life measurement, the method of assessment, and the competing advantages and disadvantages of disease-specific versus general health outcome measurement. Recommendations for proceeding with quality-of-life measurement in oncology are provided to encourage increased attention to the need to remain closely tied to a theoretical construct.
Adult↗
Quality of life in people with Hodgkin's disease.
The diagnosis and treatment of Hodgkin's disease are not without cost in terms of both short- and long-term sequelae that have an impact on quality of life. This paper reviews quality of life in Hodgkin's disease both during and after treatment, with a focus on medical, psychosocial, and psychological functioning. In general, patients with Hodgkin's disease emerge from successful treatment significantly affected. Often, the impact of the disease and its treatment has both positive and negative aspects. Positive effects include increased appreciation for life, enhanced self-esteem and sense of personal direction, and closer family ties. Negative effects include risk of second malignancy, infertility, difficulty with intimacy and sexuality, employment discrimination, insurance discrimination, increased general distress, and fear of recurrence. The many and diverse needs of Hodgkin's disease survivors merit increased attention from the health-care delivery system.
Adult↗
Comparison of psychosocial adaptation and sexual function of survivors of advanced Hodgkin disease treated by MOPP, ABVD, or MOPP alternating with ABVD.
BACKGROUND: Survivors of advanced Hodgkin disease, who were assigned randomly to treatment by mechlorethamine, vincristine, procarbazine, and prednisone (MOPP); doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD); or MOPP alternating with ABVD in a clinical trial of the Cancer and Leukemia Group B (protocol 8251), were compared in terms of their psychosocial adaptation and psychosexual function an average of 2.2 years after completion of treatment (range, 1-5 years). The study was undertaken to determine if there were differences among treatments in these functional areas as a consequence of differential long-term gonadal damage in the three regimens. METHODS: Ninety-three disease-free survivors of advanced Hodgkin disease (56 men and 37 women) were studied (a minimum of 1 year after completion of treatment) by an interview conducted over the telephone. Standardized measures were used to assess their psychologic, sexual, family, and vocational functioning, including the following tests: the Psychosocial Adjustment to Illness Scale--Self Report, the Brief Symptom Inventory, the Profile of Mood States, and the Impact of Event Scale. RESULTS: Contrary to expectation, no statistically significant differences in survivors' psychosocial adaptation or psychosexual function were found by treatment arm. Infertility (based on survivors' reports of medical test results and perceptions) and lower income 1 year before the diagnosis of cancer were significant predictors of poorer adjustment. Most survivors reported a range of problems that they attributed to having had cancer: 35%, proven or perceived infertility; 24%, sexual problems; 31%, health and life insurance problems; 26%, a negative socioeconomic effect; and 51%, conditioned nausea, associated with visual or olfactory reminders of chemotherapy. CONCLUSIONS: No significant long-term advantage in psychosocial adaptation or psychosexual function was found for survivors of Hodgkin disease treated by the less gonadally toxic ABVD regimen 1 to 5 years after completion of treatment.
Adaptation, Psychological↗