Short summary

Immune checkpoint inhibitors (ICI) have improved the survival of patients with cancer and a broad variety of cancer types are not treated with ICI. However, severe side effects (irAEs) are difficult to identify and handle. The aim of this project is to tailor innovative educational material on ICI with and for cancer patients and caregivers taking into account their level of health literacy. Three sub-studies will be carried out: literature review, co-design study, and a randomized pilot study.

Rationale

Aim: the project aims to develop, test, and implement innovative educational materials on immunotherapy, thereby optimizing patients' with cancer and their caregivers' ability to identify and respond timely to side effects. The project is conducted in collaboration with and for patients with cancer and their caregivers, with consideration given to ensuring that the materials are suitable for varying levels of vulnerability and health literacy.

Description of the cohort

Patients diagnosed with malignant melanoma, lung cancer, head and neck cancer, or kidney cancer and to be treated with ICI are eligible for participation in this study. Furthermore, we will include their caregivers. Patients will be recruited from outpatients clinics at Department of Oncology, OUH, Odense University Hospital and Department of Oncology, Rigshospitalet.

Data and biological material

Demographic data and information about diagnosis will be gathered. Furthermore, the following questionnaires will be used: National Comprehensive Cancer Network Distress Thermometer (NCCN DT), 2-item Connor-Davidson Resilience Scale (CD-RISC-2), Health Literacy Questionnaire (HLQ), General Self-Efficacy Scale, EORTC QLQ-C30, and 12-item Short-Form Health survey. Qualitative interviews will also be conducted.

Collaborating researchers and departments

Department of Oncology, Rigshospitalet

• Helle Pappot