Kirin Saint, Tina Paul, Clare Patterson, Mingxiao Yang, Ting Bao, Mary Lou Galantino
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Leveraging fidelity measures for community-based, complex interventions and yoga therapy reporting guidelines, we developed an instructor/participant-oriented fidelity checking approach in an ongoing phase III trial evaluating yoga for improving chemotherapy-induced peripheral neuropathy in cancer survivors. Two researchers independently assessed 4 of 8 video recordings of yoga instructor-led training sessions (50%) and participant-kept home practice logs using a developed fidelity checklist.</p><p><strong>Results: </strong>None of the 4 eligible yoga trials specifically have intervention fidelity measures. We prospectively incorporated yoga instructor training, virtual delivery, and participant engagement strategies in the phase III trial protocol following guidelines. All trial yoga instructors were trained under study protocol to ensure compliance and participant engagement. There was high intervention fidelity in all instructor-led virtual sessions: an average of 100% adherence to class structure and three-thirds on specific skills. Assessment of participant adherence to the established home yoga protocol was 63%.</p><p><strong>Conclusion: </strong>Yoga trials for chemotherapy-induced peripheral neuropathy need adequate fidelity measures. 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引用次数: 0
摘要
背景:瑜伽干预措施需要保真度监控,以规范试验过程并确保坚持。我们研究了当前瑜伽试验的忠实性措施,并在一项针对癌症幸存者化疗引起的周围神经病变的 III 期随机临床试验中制定了忠实性保证流程:我们通过在PubMed上搜索从开始到2023年2月的文献,定性分析了已发表的瑜伽疗法治疗化疗引起的周围神经病变的临床试验中的保真度监测内容。利用基于社区的复杂干预措施的忠实性测量方法和瑜伽疗法报告指南,我们在一项正在进行的III期试验中开发了一种以指导者/参与者为导向的忠实性检查方法,该试验评估了瑜伽改善癌症幸存者化疗引起的周围神经病变的效果。两名研究人员使用开发的忠实性检查表独立评估了 8 个瑜伽教练指导的培训课程录像中的 4 个(50%)以及参与者保存的家庭练习日志:结果:符合条件的 4 项瑜伽试验中没有一项专门针对干预的忠实性措施。我们根据指南,将瑜伽指导员培训、虚拟授课和参与者参与策略前瞻性地纳入了 III 期试验方案。所有试验的瑜伽指导员都根据研究方案接受了培训,以确保符合要求和参与者的参与。在所有由教练指导的虚拟课程中,干预的忠实度都很高:对课堂结构的遵守率平均为 100%,对特定技能的遵守率平均为三分之二。参与者对既定家庭瑜伽方案的依从性评估为 63%:结论:针对化疗引起的周围神经病变的瑜伽试验需要足够的保真度措施。我们的研究提供了一种可行的保真度监控方法,以确保在肿瘤环境中进行试验干预时,指导者和参与者都能遵守协议。
Assessing Fidelity in Yoga Interventions for Chemotherapy-Induced Peripheral Neuropathy: Decision-Making to Enhance Protocol Quality Adherence.
Background: Yoga interventions need fidelity monitoring to standardize the trial process and ensure adherence. We examined fidelity measures of current yoga trials and developed a fidelity assurance process in a phase III randomized clinical trial addressing chemotherapy-induced peripheral neuropathy among cancer survivors.
Methods: We qualitatively analyzed the fidelity monitoring components in published clinical trials on yoga therapy for chemotherapy-induced peripheral neuropathy through a literature search in PubMed from inception to February 2023. Leveraging fidelity measures for community-based, complex interventions and yoga therapy reporting guidelines, we developed an instructor/participant-oriented fidelity checking approach in an ongoing phase III trial evaluating yoga for improving chemotherapy-induced peripheral neuropathy in cancer survivors. Two researchers independently assessed 4 of 8 video recordings of yoga instructor-led training sessions (50%) and participant-kept home practice logs using a developed fidelity checklist.
Results: None of the 4 eligible yoga trials specifically have intervention fidelity measures. We prospectively incorporated yoga instructor training, virtual delivery, and participant engagement strategies in the phase III trial protocol following guidelines. All trial yoga instructors were trained under study protocol to ensure compliance and participant engagement. There was high intervention fidelity in all instructor-led virtual sessions: an average of 100% adherence to class structure and three-thirds on specific skills. Assessment of participant adherence to the established home yoga protocol was 63%.
Conclusion: Yoga trials for chemotherapy-induced peripheral neuropathy need adequate fidelity measures. Our study provides a feasible fidelity-monitoring approach to ensure trial intervention delivery and protocol adherence by instructors and participants in oncological settings.
期刊介绍:
ICT is the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. Contributors are leading oncologists, researchers, nurses, and health-care professionals.