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Translation and Cultural Adaptation of the MYCaW(R) Questionnaire into German: The iSWOP Study Protocol

Thronicke, A.; Schille, L.; Adie, K.; Junghanss, C.; Oei, S. L.; Johnson, S. K.; Roos, J.; Schad, F.

2025-03-17 oncology
10.1101/2025.03.17.25324105 medRxiv
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IntroductionThe 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 are essential for understanding and improving survivors subjective experiences. This protocol outlines the systematic translation and cultural adaptation of the Measure Yourself Concerns and Wellbeing (MYCaW(R)) questionnaire into German. The MYCaW(R) 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 and analysisFollowing 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 studys strengths (systematic methodology, patient-centered approach, expert oversight, clinical utility) and limitations (preliminary validation sample size, potential bias in translation) provide a balanced view of the studys rigorous design and areas where further research or refinement could improve its reliability and generalizability. Ethics and disseminationsEthics committee of the the Medical Association Berlin (Arztekammer Berlin) (reference number Eth-27/10) gave ethical approval for this work. The findings will be presented at scientific conferences and submitted for publication in peer-reviewed journals. Trial registration numberThe study was registered at the German Register for Clinical Trials under DRKS00013335 on 27/11/2017.

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