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- Title
The functional assessment of cancer therapy-BRM (FACT-BRM): a new tool for the assessment of quality of life in patients treated with biologic response modifiers.
- Authors
Bacik, J.; Mazumdar, M.; Murphy, B. A.; Fairclough, D. L.; Eremenco, S.; Mariani, T.; Motzer, R. J.; Cella, D.
- Abstract
<bold>Purpose: </bold>This paper reports on the development and validation of two biologic response modifier (BRM) subscales for use with the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life (QOL) questionnaire.<bold>Methods: </bold>Using the FACT-G as a base, 17 additional questions related to symptoms common to interferon and retinoid therapy were developed. Data collected at baseline (n = 191) and week 2 (n = 168) in a randomized trial of interferon +/- 13-cis-retinoic acid in advanced renal cell carcinoma patients were used to validate this measure.<bold>Results: </bold>Using a combined empirical and conceptual approach, the 17 questions were reduced to 13 questions consisting of two subscales: 'BRM-physical' (7 items; baseline coefficient alpha(alpha) = 0.70; week-2 alpha = 0.75) and 'BRM-mental' (6 items; baseline alpha = 0.79; week-2 alpha = 0.78). Internal consistency of the trial outcome index (TOI) combining physical well-being, functional well-being and the BRM subscales, was 0.91 for baseline assessments and 0.92 for week 2. Discriminant validity was demonstrated for the TOI by its ability to differentiate among prognostic risk groups, and for the total FACT-G, TOI and total FACT-BRM scores by their ability to distinguish between groups differing in performance, response and toxicity status.<bold>Conclusions: </bold>The 'BRM-physical' and 'BRM-mental' subscales can be combined with the FACT-G to form the 'FACT BRM' scale, useful for measuring QOL in cancer patients who are receiving treatment with biologic response modifiers.
- Subjects
QUALITY of life; HEALTH; CANCER treatment; CANCER patients; LIFE; RENAL cell carcinoma; BIOLOGY; THERAPEUTIC use of proteins; ANTINEOPLASTIC agents; BIOTHERAPY; CLINICAL trials; COMPARATIVE studies; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; PROTEINS; RECOMBINANT proteins; RESEARCH; RESEARCH funding; SELF-evaluation; SICKNESS Impact Profile; ACTIVITIES of daily living; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; SEVERITY of illness index; PSYCHOLOGY
- Publication
Quality of Life Research, 2004, Vol 13, Issue 1, p137
- ISSN
0962-9343
- Publication type
journal article
- DOI
10.1023/B:QURE.0000015297.91158.01