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 α = .85; r = .81) and the total FACT‐Melanoma (α = .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. Cancer 2008. © 2008 American Cancer Society.

Nonprogression with Avelumab Treatment Associated with Gains in Quality of Life in Metastatic Merkel Cell Carcinoma

“…Mean FACT-M scores were lower than reported in a previous study of patients with stage IV melanoma [24,44]. This could be due to the fact that MCC is in general a more aggressive tumor than melanoma [6].…”

“…Currently, no validated tools exist to capture HRQoL in patients with MCC. The FACT-M had been developed to address disease-specific QoL concerns among patients with melanoma, and it has subsequently been validated for use in patients with all stages of the disease [24,30]. MCC and melanoma are both aggressive skin malignancies; despite some differences between MCC and melanoma, including worse prognosis for MCC, the content of the FACT-M seems appropriate to assess QoL in patients with MCC.…”

“…However, differences between the two studies at baseline could also be impacted by other characteristics of the underlying populations; such as type of treatment or patient age. Mean age of melanoma patients by disease stage was not reported, however, it is likely that patients with stage IV melanoma were younger than those with mMCC, as median age in the overall melanoma study population (including stage I-IV) was only 52 years, as compared with 72.5 in the JAVELIN Merkel 200 trial [24].…”

“…The FACT-M comprises 51 items grouped into nine multi-item scores, including six subscale scores and three summary scores [24,30]. The six subscales consist of four subscales from the FACT -General (FACT-G; physical wellbeing, social wellbeing, emotional wellbeing, functional wellbeing), one melanoma scale and one melanoma surgery scale.…”

Optimal follow-up for melanoma

“…The Distress Thermometer and problem list [217], its Dutch version for the Netherlands [80], or the recently developed melanoma-specific Functional Assessment of Cancer Therapy (FACT-M) qualityof-life questionnaire [81] may assist doctors in more accurately identifying those patients who suffer from significant levels of distress and are in need of psychoeducational interventions or reassurance through more intensive follow-up.…”