Living with melanoma: a study protocol for the design and participatory development of a survivorship care programme for people with metastatic melanoma

Background: The growing number of people living with and beyond melanoma report unmet needs in survivorship care. To optimize melanoma survivorship care, it is critical to consider not only the perspectives of survivors of melanoma and their relatives, but also those of oncology healthcare professionals. The aim of this study is to develop an innovative survivorship care programme for people living with and beyond metastatic melanoma. Methods: The study follows the UK Medical Research Council framework and the intervention mapping approach. It also integrates the perspectives of all relevant stakeholders, from survivors of melanoma and their families to healthcare professionals. The development process (phase A) includes a scoping review and a qualitative study with interviews and focus groups. Stakeholder knowledge will be integrated through a participatory process involving patients, relatives, physicians, psycho-oncologists, nurses, epidemiologists and health services researchers. Discussion: Using different methodological approaches, we hope to gain insight into the needs of survivors of melanoma and develop a theory- and evidence-based survivorship care programme. The planned study will provide a patient-centred intervention to improve health-related outcomes for people with metastatic melanoma in general and to promote health literacy and quality of life for those affected. The subsequent feasibility and pilot study, including a structure and process evaluation (phase B), will provide an initial opportunity to determine the feasibility of a randomized controlled trial and of the survivorship care programme itself, in preparation for further effectiveness studies. Protocol registration: We set up an OSF project (https://doi.org/10.17605/OSF.IO/DV7MH) for the LeMela project. In addition, we have pre-registered a short protocol at OSF (https://doi.org/10.17605/OSF.IO/QVRXD).