Translation and Cultural Adaptation of the MYCaW® Questionnaire into German: The iSWOP Study Protocol

Introduction 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 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®) 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.

and analysis 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’s 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 study’s rigorous design and areas where further research or refinement could improve its reliability and generalizability. Ethics and disseminations Ethics committee of the the Medical Association Berlin (Ärztekammer 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 number The study was registered at the German Register for Clinical Trials under DRKS00013335 on 27/11/2017. Competing Interest Statement FS reports grants from Helixor Heilmittel GmbH (travel costs and honoraria for speaking), grants from AstraZeneca (travel costs and honoraria for speaking), and grants from Abnoba GmbH, outside the submitted work. AT reports grants from the Medical Section of the Goetheanum (honoraria for speaking), outside the submitted work. The other authors have declared that no competing interests exist. No payment was received for any other aspects of the submitted work. There are no patents, products in development or marketed products to declare. There are no other relationships/conditions/circumstances that present a potential conflict of interest. Funding Statement This study is funded through the institutional budget of the Research Institute Havelhoehe, the primary non-commercial sponsor of the study. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee of the the Medical Association Berlin (Aerztekammer Berlin) (reference number Eth-27/10) gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present work are contained in the manuscript.