Abstract
INTRODUCTION: Partners of cancer patients often show similar levels of distress like the oncological patients themselves, and they are a primary resource for the patient's physical and emotional support. Integrating self-care in daily routines is applied as a treatment approach in cognitive behavioural therapy. Carrying out self-care in caring relatives prevents anxiety and depression, enhances health-related quality of life and reduces caregiver burden. So far, there is no instrument which assesses self-care specifically in partners of cancer patients. The aim of this prospective mixed-methods validation study is to develop and psychometrically evaluate a psychological self-reported questionnaire assessing self-care in partners of cancer patients (SC-PC questionnaire). METHODS AND ANALYSIS: Recruitment of participants will take place online and offline across Germany, Austria and Switzerland. The data collection will be carried out via personal cognitive qualitative interviews and a web-based data assessment tool within four phases: (1) personal qualitative semi-structured interviews with n≈15 partners of cancer patients on self-care in different areas of life; (2) pretest of derived self-care items concerning feasibility, comprehensibility and completeness with n=3-5 (psycho-)oncological experts and n=20-30 partners of cancer patients; (3) pilot study with an exploratory factor analysis with n=300 partners of cancer patients, based on an expected initial item pool of approximately 30 items and a 10:1 item-participant ratio; and (4) main validation study with confirmatory factor analysis with n=400 partners of cancer patients, based on an expected final item pool of approximately 20 items and a 20:1 item-participant ratio. Subgroup analyses will be calculated with demographic and medical variables. ETHICS AND DISSEMINATION: A project-specific concept for data protection was established. All legal and professional regulations will be complied with. In order to meet ethical standards and protect participants from potential emotional burdens during this mainly decentralised study, ethical guidelines for online studies were implemented in the study design. The study was approved by the ethics committee of the University of Ulm (number/ID of the approval: 230/25). Results will be presented at conferences and published in scientific peer-reviewed journals for broad reach. The resulting self-care questionnaire may be implemented as a new measurement instrument in research projects investigating psycho-oncological interventions for partners of cancer patients and the practical field of cancer counselling for progress assessment. TRIAL REGISTRATION NUMBER: DRKS00038519.