Cross-cultural development of a quality-of-life measure for patients with melanoma: phase 3 testing of an EORTC Melanoma Module.

Melanoma is an increasingly common skin cancer worldwide. Recent treatment advances have provided patients and healthcare professionals (HCPs) with choices where quality of life (QoL) and toxicity are important considerations. A melanoma-specific QoL questionnaire is being developed in a cross-cultural setting using a four phase process developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. In phase 1, a literature search identified a list of pertinent QoL issues; this was shown to HCPs and patients in eight countries and rated for importance and relevance. Questions were constructed for the highest-rated issues (phase 2) and piloted in another patient sample (phase 3). Using EORTC Quality of Life Group criteria and sequential use of factor and Rasch analysis, scales were hypothesized for field testing (phase 4). Seven QoL domains (disease symptoms, treatment issues, financial issues, access/quality of information, satisfaction with care, psychosocial issues and support), comprising 73 QoL issues, were rated by 46 HCPs and 78 patients. Fifty-six issues were rephrased as questions and piloted with 132 patients. A 38-item questionnaire (QLQ-MEL38) is available for field testing in conjunction with the EORTC QLQ-C30. This study has shown that melanoma patients have important QoL issues that have been incorporated into a new cross-culturally validated instrument. Future testing of this EORTC module is planned and will be an important step forward in providing reliable QoL data to aid future decision-making in the management and clinical trials of this complex group of patients.

What are the pertinent quality-of-life issues for melanoma cancer patients? Aiming for the development of a new module to accompany the EORTC core questionnaire.

Melanoma is the most serious type of skin cancer. However, there is a paucity of evidence on the impact of melanoma on the quality of life (QoL) of patients. Only two clinically validated QoL instruments have been reported in the literature. The present study has identified contemporary QoL issues during a time of great change for melanoma treatment, as a precursor to an international study to develop a new melanoma-specific QoL instrument. Twenty-two melanoma patients (American Joint Committee on Cancer stages I-IV) and 10 close family members were recruited from a metropolitan tertiary referral clinical and research centre in Sydney, Australia, to participate in interview or focus group discussions. Verbatim transcripts of these recorded interviews were systematically analysed. Seventy-three issues across seven health-related QoL domains were identified. Issues across three domains featured highly; psychosocial, availability of support and information. Given the current rapid evolution of systemic therapies for melanoma, the challenges associated with treatment choices and clinical trial participation were also highlighted in this sample. Although some issues were generic in nature, experienced by many cancer patients, this study revealed that the wide range and intensity of QoL issues reported by melanoma patients are not adequately evaluated in current QoL instruments. With the increasing importance of patient reported outcome measurement, this list has been transformed into questionnaire items, in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Group, for testing a new melanoma-specific QoL module for use with the EORTC core questionnaire (QLQ-C30).