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Assessing Fidelity in Yoga Interventions for Chemotherapy-Induced Peripheral Neuropathy: Decision-Making to Enhance
Kirin Saint1, Tina Paul2, Clare Patterson2
1University of Michigan Medical School, Ann Arbor, MI, USA.
Integrative Cancer Therapies
|July 27, 2024
Summary
This study highlights the need for robust fidelity measures in yoga trials for chemotherapy-induced peripheral neuropathy. A new monitoring approach ensures adherence in cancer survivor studies.
Area of Science:
- Oncology
- Integrative Medicine
- Clinical Trials
Background:
- Yoga interventions require fidelity monitoring for standardized trial processes and adherence.
- Current yoga trials for chemotherapy-induced peripheral neuropathy often lack specific intervention fidelity measures.
- Developing effective fidelity assurance is crucial for reliable research outcomes.
Purpose of the Study:
- To examine fidelity measures in existing yoga trials for chemotherapy-induced peripheral neuropathy.
- To develop and implement a fidelity assurance process in a phase III randomized clinical trial.
- To improve the standardization and adherence of yoga interventions in cancer survivors.
Main Methods:
- Qualitative analysis of fidelity monitoring in published yoga therapy trials for chemotherapy-induced peripheral neuropathy (PubMed search up to Feb 2023).
- Development of an instructor/participant-oriented fidelity checking approach based on existing guidelines.
- Independent assessment of yoga instructor training sessions (video recordings) and participant home practice logs using a fidelity checklist in an ongoing phase III trial.
Main Results:
- No eligible yoga trials identified had specific intervention fidelity measures.
- The phase III trial incorporated prospective strategies: instructor training, virtual delivery, and participant engagement.
- High intervention fidelity was observed in instructor-led virtual sessions (100% adherence to structure, high adherence to skills).
- Participant adherence to the home yoga protocol was 63%.
Conclusions:
- Yoga trials for chemotherapy-induced peripheral neuropathy necessitate adequate fidelity measures for accurate results.
- The study presents a feasible fidelity-monitoring approach for ensuring intervention delivery and protocol adherence in oncological settings.
- This approach supports both instructors and participants in maintaining fidelity within clinical trials.
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