The Yinota-O-trial: Efficacy of an online yoga-intervention in high-grade glioma patients and their caregivers – patient-reported outcomes and serum stress parameters - a study protocol of a randomized controlled trial

Background: 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 to a waiting control group (WCG). Methods: : The study is designed as a multicenter randomized controlled trial. Adult glioma patients (CNS WHO grades 3 & 4) and their caregivers will be recruited. Examined yoga instructors deliver the intervention (1 h/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 generalized anxiety and secondary outcomes are self-reported progression anxiety, depression, quality of life as well as BDNF, DHEA/DHEAS, Ferritin and hair cortisol. We hypothesize better outcomes in the intervention group (IG) compared to the WCG at all measurement points. 70 patients and 70 caregivers will be recruited consecutively. Primary endpoints are significant effect detections in the Generalized Anxiety Disorder Scale-7 of patients and caregivers at the end of the intervention. Analyses of covariance will be performed to analyze treatment effects. Discussion: This is the first study to analyze the effectiveness of mindfulness-based online yoga for high-grade glioma patients and their caregivers with well-defined inclusion criteria. The consideration of biochemical stress markers will objectively increase the validity of self-reports in addition to supporting results of previous studies on yoga for cancer patients. If online yoga therapy proves effective, it could make yoga classes more attractive compared to face-to-face classes, as glioma patients are often limited in their mobility and caregivers have less time due to caregiving. Trail registration: German Clinical Trial Register (Nr. DRKS00029554, 08/2022).