Study protocol for a multicentre randomised controlled trial evaluating the efficacy of an online yoga intervention in high-grade glioma patients and their caregivers: the YINOTA-O-trial.

in BMJ open by Antonia Rabe, Almuth Friederike Keßler, Carsten Hagemann, Jörg Schubert, Elisabeth Jentschke

TLDR

  • This study aims to investigate the effects of online yoga on emotional distress, quality of life, and physiological parameters in high-grade glioma patients and their caregivers during an 8-week randomized controlled trial.

Abstract

High-grade glioma patients and their caregivers often suffer from distress and a lower quality of life. Results from studies with patients with mixed cancer entities suggest that yoga can be an effective support. However, it is unclear whether this also applies to high-grade glioma patients and their caregivers. This study aims to investigate the effects of mindfulness-based online yoga for patients and their caregivers on emotional distress, quality of life and stress-associated physiological parameters compared with a waiting control group (WCG). The study is designed as a multicentre randomised controlled trial. Adult glioma patients (central nervous system WHO grades 3 and 4) and their caregivers will be recruited. Examined yoga instructors deliver the intervention (1 hour per week) in a synchronous format over 8 weeks via video conferencing. The WCG will receive standard care during the 8-week waiting period. Data will be collected before and after the end of the intervention and another 3 months later using questionnaires as well as blood serum and hair samples to evaluate biochemical stress parameters. Primary outcome is self-reported generalised anxiety and secondary outcomes are self-reported fear of progression, depression and quality of life as well as brain-derived neurotrophic factor (BDNF), dehydroepiandrosterone (DHEA)/dehydroepiandrosterone sulfate (DHEAS), ferritin and hair cortisol. We hypothesise better outcomes in the intervention group compared with the WCG at all measurement points. 70 patients and 70 caregivers will be recruited consecutively. Primary endpoints are significant effect detections in the Generalised Anxiety Disorder scale-7 of patients and caregivers at the end of the intervention. Analyses of covariance will be performed to analyse the treatment effects. The Ethics Committee of the University of Würzburg approved the YINOTA-O (oga-ntervention beieuroonkologischenumorpatienten und derenngehörigen -nline) study on 26 October 2021 (No.185/18-me). Results will be presented at conferences and published in peer-reviewed journals. German Clinical Trials Register No. DRKS00029554.

Overview

  • The study aims to investigate the effects of mindfulness-based online yoga on emotional distress, quality of life, and stress-associated physiological parameters in high-grade glioma patients and their caregivers.
  • Participants will be randomly assigned to either an intervention group receiving online yoga sessions or a waiting control group receiving standard care.
  • The primary outcome is self-reported generalised anxiety, and secondary outcomes include fear of progression, depression, quality of life, and biochemical stress parameters.

Comparative Analysis & Findings

  • The study will compare the effects of the online yoga intervention on the primary and secondary outcomes between the intervention group and the waiting control group.
  • Significant effect detections in the Generalised Anxiety Disorder scale-7 will be the primary endpoints for patients and caregivers at the end of the intervention.
  • Analyses of covariance will be performed to analyse the treatment effects and detect significant differences between the groups.

Implications and Future Directions

  • The study will contribute to the understanding of the effectiveness of online yoga interventions in improving emotional distress, quality of life, and physiological parameters in high-grade glioma patients and their caregivers.
  • Future studies may explore the long-term effects of the intervention and the role of other mindfulness-based approaches in supporting patients and caregivers.
  • The study's findings may inform the development of online yoga programs for patients and caregivers with various types of cancer and could be adapted for use in different clinical settings.
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