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: OBJECTIVE
  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(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.
  
  
  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.
authors.affiliation: Department of Epidemiology and Biostatistics a Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors.forename: J
authors.initials: J
authors.lastname: Bacik
authors.forename: M
authors.initials: M
authors.lastname: Mazumdar
authors.forename: B A
authors.initials: BA
authors.lastname: Murphy
authors.forename: D L
authors.initials: DL
authors.lastname: Fairclough
authors.forename: S
authors.initials: S
authors.lastname: Eremenco
authors.forename: T
authors.initials: T
authors.lastname: Mariani
authors.forename: R J
authors.initials: RJ
authors.lastname: Motzer
authors.forename: D
authors.initials: D
authors.lastname: Cella
mesh_terms: D000203:Activities of Daily Living; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001691:Biological Therapy / Q000009:adverse effects / Q000706:statistics & numerical data; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011788:Quality of Life; D011994:Recombinant Proteins; D012647:Self-Assessment; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins