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 Journal Article

Authors: Bacik, J.; Mazumdar, M.; Murphy, B. A.; Fairclough, D. L.; Eremenco, S.; Mariani, T.; Motzer, R. J.; Cella, D.
Article 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
Abstract: Purpose: 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. Methods: 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. Results: 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(α) = 0.70; week-2 α = 0.75) and 'BRM-mental' (6 items; baseline α = 0.79; week2 α = 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. Conclusions: 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.
Keywords: adult; controlled study; treatment outcome; aged; functional assessment; major clinical study; clinical trial; fatigue; interferon; advanced cancer; diarrhea; side effect; skin toxicity; validation process; antineoplastic agents; conference paper; cancer patient; neurotoxicity; follow-up studies; quality of life; controlled clinical trial; anemia; leukopenia; mucosa inflammation; nausea; randomized controlled trial; stomatitis; thrombocytopenia; vomiting; analytic method; cancer therapy; renal cell carcinoma; kidney carcinoma; risk assessment; questionnaires; arthralgia; chill; fever; questionnaire; gastrointestinal toxicity; sickness impact profile; depression; symptom; severity of illness index; carcinoma, renal cell; cardiotoxicity; scoring system; muscle weakness; xerostomia; outcomes research; malignant neoplastic disease; isotretinoin; biological therapy; memory disorder; toxicity; dry eye; eye toxicity; retinoid; self assessment (psychology); performance; wellbeing; activities of daily living; qualitative analysis; biological response modifier; sweating; appetite disorder; interferon alfa-2a; quality of life assessment; humans; prognosis; human; male; female; priority journal; biologic response modifiers; fact-brm; fact-g
Journal Title: Quality of Life Research
Volume: 13
Issue: 1
ISSN: 0962-9343
Publisher: Springer  
Date Published: 2004-02-01
Start Page: 137
End Page: 154
Language: English
DOI: 10.1023/b:qure.0000015297.91158.01
PROVIDER: scopus
PUBMED: 15058795
Notes: Qual. Life Res. -- Cited By (since 1996):24 -- Export Date: 16 June 2014 -- CODEN: QLREE -- Source: Scopus
Citation Impact
MSK Authors
  1. Robert Motzer
    1130 Motzer
  2. Madhu Mazumdar
    127 Mazumdar
  3. Jennifer M Bacik
    46 Bacik