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.

Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes.

BACKGROUND: Yoga is a meditative movement therapy focused on mind-body awareness. The impact of yoga on health-related quality of life (HRQOL) outcomes in patients with chemotherapy-induced peripheral neuropathy (CIPN) is unclear. METHODS: We conducted a pilot randomized wait-list controlled trial of 8 weeks of yoga (n = 21) versus wait-list control (n = 20) for CIPN in 41 breast and gynecological cancer survivors with persistent moderate to severe CIPN. HRQOL endpoints were Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI), and Insomnia Severity Index (ISI). The Treatment Expectancy Scale (TES) was administered at baseline. We estimated mean changes and 95% confidence intervals (CIs) from baseline to weeks 8 and 12 and compared arms using constrained linear mixed models. RESULTS: At week 8, HADS anxiety scores decreased -1.61 (-2.75, -0.46) in the yoga arm and -0.32 (-1.38, 0.75) points in the wait-list control arm (p = 0.099). At week 12, HADS anxiety scores decreased -1.42 (-2.57, -0.28) in yoga compared to an increase of 0.46 (-0.60, 1.53) in wait-list control (p = 0.017). There were no significant differences in HADS depression, BFI, or ISI scores between yoga and wait-list control. Baseline TES was significantly higher in yoga than in wait-list control (14.9 vs. 12.7, p = 0.019). TES was not associated with HADS anxiety reduction and HADS anxiety reduction was not associated with CIPN pain reduction. CONCLUSIONS: Yoga may reduce anxiety in patients with CIPN. Future studies are needed to confirm these findings. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03292328.