RESUMO
AIMS: We aimed to develop a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) module tailored for patients with advanced (resectable or unresectable stage III/IV) melanoma receiving immune checkpoint inhibitors or targeted therapy. METHODS: Following the EORTC QoL Group module development guidelines, we conducted phases 1 and 2 of the development process. In phase 1, we generated a list of health-related (HR)QoL issues through a systematic literature review and semi-structured interviews with healthcare professionals (HCPs) and patients with advanced melanoma. In phase 2, these issues were converted into questionnaire items to create the preliminary module. RESULTS: Phase 1: we retrieved 8006 articles for the literature review, of which 35 were deemed relevant, resulting in 84 HRQoL issues being extracted to create the initial issue list. Semi-structured interviews with 18 HCPs and 28 patients with advanced melanoma resulted in 28 issues being added to the initial issue list. Following EORTC module development criteria, 26 issues were removed, and two issues were added after review by patient advocates. Phase 2: To ensure uniformity and avoid duplication, 16 issues were consolidated into eight items. Additionally, an independent expert contributed one new item, resulting in a preliminary module comprising 80 HRQoL items. CONCLUSION: We identified a range of HRQoL issues (dry skin, xerostomia, and arthralgia) relevant to patients with stage III/IV melanoma. Future module development phases will refine the questionnaire. Once completed, this module will enable standardized assessment of HRQoL in patients with (locally) advanced melanoma.
RESUMO
BACKGROUND: The Caregiver Inventory (CGI), a measure of self-efficacy for caregiving that takes into account aspects of caregiving that are neglected by current measures of caregiving, was translated into Italian and validated. METHODS: Ninety-one caregivers from a variety of locations in Italy completed the CGI-Italian (CGI-I) as well as the Hospital Anxiety and Depression Scale (HADS) and the Family Strain Questionnaire - Short Form (FSQ-SF). RESULTS: A confirmatory factor analysis based on the original CGI factor structure resulted in an adequate fit of the CGI-I using standard fit indices. Thus, the original factor structure was validated in the CGI-I: Managing Medical Information (α = 0.87), Caring for Care Recipient (α = 0.68), Caring for Oneself (α = 0.78), and Managing Difficult Interactions/Emotions (α = 0.55). The CGI-I total score was inversely related to anxiety (HADS, r = - 0.35, p = <.05), and depression (HADS, r = - 0.45, p = <.05). In addition, the CGI-I was inversely related to caregiver stress (FSQ-SF, r = - 0.39, p = <.05). Care of Oneself and Managing Difficult Interactions/Emotions emerged as the strongest and most robust negative relationships with anxiety, depression, and caregiver stress, which replicated, with similar constructs, findings from the original CGI. CONCLUSIONS: The results of this study established the CGI-I as a reliable and valid measure of self-efficacy for caregiving. This study also confirms the importance of self-care and managing difficult communication in the process of successfully navigating the demands of caregiving and in constructing interventions for caregivers who need support.
