Randomized Controlled Trial of Isha Kriya versus Observation to Improve Quality of Life in Hematopoietic Cell Transplantation Recipients

Abstract

Hematopoietic cell transplantation (HCT) impacts its recipients' quality of life (QoL). Few mindfulness-based interventions (MBI) in HCT recipients have shown feasibility, but heterogeneous practices and outcome measures have questioned the real benefit. We hypothesize that a self-guided meditation as a mobile app will improve QoL in the acute HCT setting. This single-center, open-label, randomized controlled trial was conducted in 2021-2022. The study was cleared by Institutional Ethics Committee and registered at the Clinical Trial Registry of India. Recipients were included after obtaining written informed consent. Recipients without access to smartphones or regular practitioners of yoga, meditation, or other mind-body practice were excluded. Autologous + allogeneic HCT recipients of age ≥ 18 years were included in the study. Recipients were randomized to the control arm or Isha kriya arm in a 1:1 ratio stratified by type of transplant. Patients in the Isha kriya arm were recommended to perform the kriya twice daily from pre-HCT to day+30 post-HCT. Isha Kriya is 12-minute guided meditation based on the principles of yoga, focussing on breath, awareness, and thought. The primary endpoint was the QoL summary scores assessed by the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) and the Patient-Reported Outcomes Measurement Information System–Global Health (PROMIS-GH) questionnaires. The secondary endpoints were the difference in QoL domain scores. The validated questionnaires were self-administered before the intervention, day +30, and day +100 after HCT. The analysis of endpoints was done on an intention-to-treat basis. Domain and summary scores were calculated for each instrument as recommended by the developers. A p-value <0.05 was used for statistical significance, and cohen's d effect size determined clinical significance. A total of 72 HCT recipients were randomized to the Isha kriya and the control arm. Patients in both arms were matched for age, gender, diagnosis, and type of HCT. Both arms had no difference in the pre-HCT QoL domain, summary, and global scores. Post-HCT at day+30, there was no difference in the mean FACT-BMT total scores (112.9 ± 16.8 vs.101.2 ± 13.9, p = 0.2) and the mean global health scores (Global mental health 45.1 ± 8.6 vs. 42.5 ± 7.2, p = 0.5, global physical health 44.1 ± 6.3 vs. 44.1 ± 8.3, p = 0.4) in the two groups. There was similarly no difference in the physical, social, emotional, and functional domain scores. However, the mean BMT-subscale scores, which addresses BMT-specific quality-of-life concerns, were statistically and clinically significantly higher in the Isha kriya arm than the control arm (27.9 ± 5.1 vs. 24.4 ± 9.2, p = 0.03, Cohen's d 0.5, medium effect size). This effect was transient as the day+100 scores showed no difference (28.3 ± 5.9 vs. 26.2 ± 9.4, p = 0.3). Isha kriya did not improve the FACT-BMT total and global health scores in the acute HCT setting. However, practicing Isha kriya for a month did show a transient improvement in the FACT-BMT subscale scores on day +30 but not on day +100 post-HCT.