OncoSkin Defence: Patient-Reported Outcomes and Experiences of Radiation Dermatitis in an Oncological Population: A Mixed-Methods Study Protocol

Abstract

Introduction. Radiation dermatitis affects up to 95% of patients undergoing radiotherapy, significantly impacting quality of life through symptoms such as pain, pruritus, sleep disturbance, and social discomfort. The tools commonly used to assess these conditions focus on observable clinical signs and fail to capture patient-reported outcomes and experiences. The role of patient-reported outcome measures (PROMs) has become increasingly prominent in contemporary cancer care. Their integration into oncology practice has been shown to enhance QoL and, in some cases, survival, with effects likely mediated by improved symptom monitoring, early intervention, and greater tolerance to treatment regimens. The aim of this study is to explore and characterize the lived experiences and patient-reported outcomes of individuals undergoing radiotherapy who develop radiation dermatitis (RD).

Methods. A convergent mixed-methods study will be performed according to Creswell’s framework. The qualitative component will explore patients’ lived experiences, while the quantitative component will assess outcomes using validated PROMs (Skindex-16, Pittsburgh Sleep Quality Index, Body Image Scale, and Patient Activation Measure-13). Participants will be adult oncology patients (≥18 years) undergoing radiotherapy, diagnosed with RD classified according to CTCAE v5.0, able and willing to provide informed consent, and able to read and speak Italian. Quantitative and qualitative data will be analysed independently, accorded equal weighting, and subsequently integrated.

Results. This study is expected to fill a significant gap in the existing literature by exploring the lived experiences of patients with radiation dermatitis and assessing their patient-reported outcomes, stratifying the findings according to cancer type. The study is expected to generate a comprehensive understanding of both the clinical and experiential dimensions of radiation-induced skin toxicity in oncology.

Discussion. The integration of findings will inform the development of the OncoSkin Defence Model, a patient-centred and evidence-informed framework aimed at enhancing nursing assessment, patient education, and symptom management in patients undergoing radiotherapy.