Relationship between physician-adjudicated adverse events and patient-reported health-related quality of life in a phase II clinical trial (NCT01143402) of patients with metastatic uveal melanoma
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.