A systematic review of the literature on quality of life (QOL) in melanoma patients suggested an overwhelming need for a disease-specific subscale. A melanoma subscale for the Functional Assessment of Cancer Therapy (FACT-Melanoma) was developed to meet this need. This instrument was developed in three stages. In stage I, the literature was comprehensively reviewed, and over 300 cancer-specific items from the Functional Assessment of Chronic Illness Therapy (FACIT) item bank were examined to identify questions of potential relevance to melanoma patients. In stage II, 20 melanoma experts identified questions that were relevant to melanoma patients and that were to be included in a pilot questionnaire. In stage III, the pilot questionnaire and a semistructured interview to assess item comprehension, relevance, and overall content were administered to 40 patients with various stages of melanoma. In all, 97 items were culled from the literature and the FACIT item bank; after items were reviewed and evaluated, 25 questions were retained. Most patients considered the content of the pilot questionnaire to be relevant (95%), comprehensive (60%), and easy to understand (88%). After final revisions were made, the FACT-Melanoma tool included 24 items encompassing three QOL domains: 20 items relate to physical well-being, 3 to emotional well-being,and 1 to social well-being. The face and content validity of the FACT-Melanoma assessment tool has been confirmed in melanoma patients and by professionals. Formal validation and reliability testing of the questionnaire is being determined in a prospective cohort of melanoma patients.