title: Prospective assessment of the reliability, validity, and sensitivity to change of the Functional Assessment of Cancer Therapy-Melanoma questionnaire.
abstract: BACKGROUND
  The authors previously developed a melanoma-specific module for the Functional Assessment of Cancer Therapy (FACT-Melanoma), a tool for the assessment of quality of life (QOL) in patients with melanoma. The reliability and validity of the FACT-Melanoma was examined in this study.
  
  
  METHODS
  Patients with melanoma (N = 273; stages I-IV) completed a battery of questionnaires at the time of enrollment. The validity of the instrument was examined by comparing FACT-Melanoma scores with performance status, disease stage, treatment status, and other scales, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Melanoma Module, the Profile of Mood States, and the Marlowe-Crowne Social Desirability Scale. Patients were assessed after 1 week to assess test-retest reliability and at 3 months to determine the sensitivity of the instrument to change in performance status.
  
  
  RESULTS
  The internal consistency and test-retest reliability (r) of the melanoma subscale (Cronbach alpha = .85; r = .81) and the total FACT-Melanoma (alpha = .95; r = .90) were excellent. Overall, the scales were correlated with other measures, as anticipated. Total FACT-Melanoma scores, along with scores for physical well-being, emotional well-being, functional well-being, and melanoma-specific scales, were lower for patients with advanced (stage III/IV) melanoma, poor performance status, and patients who were receiving active treatment. The FACT-Melanoma total score and the score for physical well-being were sensitive to changes in performance status (P = .0012 and P = .004, respectively).
  
  
  CONCLUSIONS
  The results of the current study indicated that the FACT-Melanoma questionnaire is a reliable and valid instrument for patients with melanoma that can be used for the assessment of QOL in clinical trials.
authors.affiliation: Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030-4009, USA. jcormier@mdanderson.org
authors.forename: Janice N
authors.initials: JN
authors.lastname: Cormier
authors.forename: Merrick I
authors.initials: MI
authors.lastname: Ross
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Gershenwald
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Lee
authors.forename: Paul F
authors.initials: PF
authors.lastname: Mansfield
authors.forename: Luis H
authors.initials: LH
authors.lastname: Camacho
authors.forename: Kevin
authors.initials: K
authors.lastname: Kim
authors.forename: Kimberly
authors.initials: K
authors.lastname: Webster
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: J Lynn
authors.initials: JL
authors.lastname: Palmer
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004644:Emotions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008545:Melanoma / Q000523:psychology* / Q000628:therapy; D008875:Middle Aged; D010808:Physical Examination; D011446:Prospective Studies; D011788:Quality of Life; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D018434:Sickness Impact Profile; D012878:Skin Neoplasms / Q000523:psychology* / Q000628:therapy; D012944:Social Support; D011795:Surveys and Questionnaires; D016896:Treatment Outcome