JMIR Publications

ABSTRACT

Background:

The growing population of cancer survivors faces persistent physical and emotional challenges that significantly impact health-related quality of life (HRQL). To address these multifaceted needs, robust and culturally adapted patient-reported outcome measures, such as the Measure Yourself Concerns and Wellbeing (MYCaW®) questionnaire, are essential for understanding and improving survivors’ subjective experiences.

Objective:

This protocol outlines the systematic translation and cultural adaptation of the Measure Yourself Concerns and Wellbeing (MYCaW®) questionnaire into German. The MYCaW® questionnaire, a patient-reported outcome measure, is designed to capture individualized concerns and assess overall well-being, particularly in cancer care settings. By adhering to common guidelines, this research will provide a tool for assessing individualized concerns and patient needs among German-speaking cancer patients.

Methods:

Following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines, this study will employ a structured methodology involving forward and backward translation, expert review, patient review process, and preliminary validation to ensure linguistic and cultural equivalence.The study is approved by the ethics committee of the Medical Association Berlin with the reference number Eth-27/10.

Results:

This study will produce a culturally and linguistically adapted German version of the MYCaW® questionnaire, following established cross-cultural adaptation guidelines. The adaptation process will include translation, expert review, and cognitive debriefing with patients and healthcare professionals to ensure linguistic clarity and cultural relevance. A standardized coding framework will be developed for analyzing patient concerns, with inter-rater reliability assessed to ensure consistency. The final German MYCaW® version is expected to maintain the conceptual integrity of the original while being accessible and meaningful for German-speaking oncology patients.

Conclusions:

The translation and adaptation of MYCaW® into German will contribute to expanding the availability of validated patient-reported outcome measures for German-speaking populations. By following rigorous international guidelines, this study aims to produce a reliable and culturally appropriate tool for assessing patient concerns and well-being in oncology and supportive care settings. Future validation studies will be necessary to assess the psychometric properties of the adapted questionnaire and its applicability in clinical and research contexts. Potential challenges, such as maintaining conceptual equivalence in translation and ensuring broad representativeness in the validation process, will be addressed through iterative refinement. Once validated, the German MYCaW® will provide a valuable resource for patient-centered research and care, helping to capture individualized concerns that might be overlooked by standardized instruments. Clinical Trial: The study is registered at the German Register for Clinical Trials under DRKS00013335 on 27/11/2017.