Yoga in Treating Sleep Disturbance in Cancer Survivors

OBJECTIVES:

Primary

* Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion.
* Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

• Standard Care Control Condition (Procedure): Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
• Yoga Intervention (YOCAS) (Procedure): The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.

Primary outcomes

• Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) [2-24 months after surgery, chemotherapy, and/or radiation therapy]: Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.

Sex: All, ages: 21 Years to 120 Years

Inclusion Criteria:

* Diagnosis of any type of cancer
* More than 1 primary cancer allowed
* Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
* Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
* Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
* Able to read English
* 21 years of age or older

Exclusion Criteria:

* No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
* No diagnosis of sleep apnea
* No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab \[Herceptin®\])
* No metastatic cancer

Participant flow

Outcome results

• Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) (Primary), Mean, units on a scale: Yoga Intervention (YOCAS) -1.96 +/- 0.25; Standard Care Control Condition -1.07 +/- 0.23 (p 0.009)

Adverse events

Serious adverse events by term

Limitations and caveats: The study did not account for components such as time or attention, as this would have required the use of a placebo yoga intervention for the YOCAS program. The results are not generalizable for all yoga types, nor for all socioeconomic backgrounds.

• Results publication: Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520. PMID 40421669
• Results publication: Arana-Chicas E, Lin PJ, Gada U, Sun H, Chakrabarti A, Mattick LJ, Rieth K, Chay CH, Ruzich J, Esparaz BT, Cupertino AP, Altman BJ, Vertino PM, Mohile SG, Mustian KM. The effect of YOCAS(c)(R) yoga on cancer-related fatigue and quality of life in older (60+) vs. younger (</= 59) cancer survivors: Secondary analysis of a nationwide, multicenter, phase 3 randomized controlled trial. J Geriatr Oncol. 2024 Nov;15(8):102076. doi: 10.1016/j.jgo.2024.102076. Epub 2024 Oct 4. PMID 39368335
• Results publication: Lin PJ, Kleckner IR, Loh KP, Inglis JE, Peppone LJ, Janelsins MC, Kamen CS, Heckler CE, Culakova E, Pigeon WR, Reddy PS, Messino MJ, Gaur R, Mustian KM. Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419855134. doi: 10.1177/1534735419855134. PMID 31165647
• Results publication: Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Palesh OG, Chandwani K, Reddy PS, Melnik MK, Heckler C, Morrow GR. Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. J Clin Oncol. 2013 Sep 10;31(26):3233-41. doi: 10.1200/JCO.2012.43.7707. Epub 2013 Aug 12. PMID 23940231

• Karen M. Mustian, PhD, Principal investigator, University of Rochester

NIH grants: U10CA037420