Introduction:

Structured physical activity may improve physical, cognitive, and social functionality, as well as overall quality of life of people with high-grade glioma. Yet, engaging them in such activities remains highly challenging due to their unique disease burden and perceived “loss of control.” A greater understanding of patients’ interests, preferences, behavioral motivations, and perceived barriers around physical activity is needed to design tailored and patient-led physical activity interventions. This protocol describes the method and ethical considerations of a cross-sectional mixed-methods study that has been developed to collect such information from glioma patients and their carers.

Methods and analysis:

The International Physical Activity Questionnaire (IPAQ 7, short form) and semi-structured interviews will be used for data collection. IPAQ scoring protocol will be followed to examine objective data and Clarke and Braun’s thematic approach will be used to analyze the interview transcripts. Ethics: Ethical approval was obtained from Cardiff University’s Research Ethics Committee and from the regional NHS Research Ethics Committee. The main ethical concerns are to maintain patients’ safety and comfort and ensure that their consent remains informed and valid throughout the recruitment, data collection, management, and dissemination stage. Risks associated with their physical condition, emotional distress, and time commitment should be continuously assessed and necessary actions should be taken accordingly.

Conclusion:

The protocol will work as a step by step guide for future researchers for developing similar qualitative research and obtaining ethical approval when involving vulnerable individuals like high-grade glioma patients in studies.

中文翻译：

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定性研究中涉及高级别胶质瘤患者及其护理人员，以促进结构性身体活动：混合方法研究方案

介绍：

有组织的体育锻炼可以改善高级神经胶质瘤患者的身体，认知和社交功能，以及他们的整体生活质量。然而，由于他们独特的疾病负担和被认为的“失控”，使他们参与此类活动仍然具有很高的挑战性。为了设计量身定制且由患者主导的体育锻炼干预措施，需要对患者的兴趣，偏好，行为动机以及围绕体育锻炼的感知障碍有更多的了解。该协议描述了一种横断面混合方法研究的方法和伦理学考虑，该研究已被开发来从神经胶质瘤患者及其护理者那里收集此类信息。

方法与分析：

国际体育活动调查表（IPAQ 7，简称）和半结构式访谈将用于数据收集。将遵循IPAQ评分协议检查客观数据，并将使用Clarke和Braun的主题方法来分析采访记录。道德规范：道德规范已获得加的夫大学研究道德规范委员会和区域NHS研究道德规范委员会的批准。道德上的主要关切是保持患者的安全和舒适，并确保在征募，数据收集，管理和传播阶段，患者的知情权仍然有效。应持续评估与他们的身体状况，情绪困扰和时间投入相关的风险，并应采取相应的措施。

结论：

该协议将为将来的研究人员提供循序渐进的指南，以便在涉及易感个体（例如高级神经胶质瘤患者）的研究中，开展类似的定性研究并获得伦理学认可。