Virtual Yoga for Insomnia in Cancer Survivors

Recruiting at 1 trial location

Overseen By Brittany LaVaute, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Sleep apnea, Restless leg syndrome, Metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The vast majority of patients with cancer experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, most of the yoga intervention was delivered in person. With the challenges and the social distancing regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is critically important and needed. Whether the yoga intervention delivered virtually to survivors provides a similar benefit of improving insomnia and sleep quality is unknown.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be receiving any form of cancer treatment except for hormonal or biologic therapy.

What data supports the effectiveness of the treatment YOCAS©® yoga for insomnia in cancer survivors?

Research shows that YOCAS©® yoga, which includes breathing exercises, postures, and meditation, significantly improves sleep quality in cancer survivors. Studies indicate that yoga is a well-tolerated exercise that can help with insomnia and sleep issues, which are common and distressing problems for cancer patients and survivors. ^{1 2 3 4 5}

Is virtual yoga safe for cancer survivors?

Research suggests that yoga, including YOCAS©® yoga, is generally well-tolerated and safe for cancer survivors, with promising evidence for improving sleep and reducing fatigue. ^{1 2 3 4 5}

How does the YOCAS©® yoga treatment for insomnia in cancer survivors differ from other treatments?

YOCAS©® yoga is unique because it combines breathing exercises, postures, and meditation to improve sleep quality without the use of medications, which can be a concern for cancer survivors due to potential drug interactions. Unlike cognitive behavioral therapy, which can be challenging to adhere to, yoga is a well-tolerated exercise that has shown promising results in improving insomnia and sleep quality among cancer survivors. ^{1 2 3 4 5}

Research Team

Karen Mustian, PhD, MPH

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for cancer survivors who've finished their surgery, chemo, or radiation between 2 months and 10 years ago. They must have trouble sleeping, be over 18, speak English, and can use the internet with a device. They shouldn't have sleep apnea or restless leg syndrome, be doing yoga already or plan to start it outside of the study.

Inclusion Criteria

I have had surgery, chemotherapy, or radiation therapy for my cancer.

I often have trouble sleeping.

I finished my cancer treatment between 2 months and 10 years ago.

Exclusion Criteria

I am a cancer survivor without sleep apnea or restless leg syndrome.

My cancer has not spread to distant parts of my body.

If you have had cancer and want to participate in the study, you should not have done yoga in the past three months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 virtual YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform

4 weeks

8 virtual sessions

Follow-up

Participants are monitored for changes in insomnia and sleep quality after treatment

1 week

Treatment Details

Interventions

• YOCAS©® yoga

Trial Overview The study tests if virtual YOCAS©® yoga helps improve sleep in cancer survivors compared to standard care. Participants are randomly placed into two groups: one does four weeks of online yoga sessions; the other continues regular care without yoga.

Participant Groups

Group I: YOCAS Experimental Treatment 1 Intervention

Cancer survivors receive 8 virtual yoga sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)

Group II: Standard Care Active Control 1 Intervention

Cancer survivors receive their standard care

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Bassett Medical Center

Collaborator

Trials

1

Recruited

40+

Findings from Research

A nationwide phase III randomized controlled trial involving 410 cancer survivors found that a 4-week yoga therapy program (YOCAS) significantly improved cancer-related fatigue (CRF) compared to standard survivorship care.

Improvements in sleep quality and reductions in daytime dysfunction were found to mediate 22% to 37% of the positive effects of yoga on CRF, suggesting that enhancing sleep may be a key mechanism through which yoga therapy benefits cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lin, PJ., Kleckner, IR., Loh, KP., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Yoga as Treatment for Insomnia Among Cancer Patients and Survivors: A Systematic Review. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Yoga for the Treatment of Insomnia among Cancer Patients: Evidence, Mechanisms of Action, and Clinical Recommendations. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

YOCAS©® Yoga Reduces Self-reported Memory Difficulty in Cancer Survivors in a Nationwide Randomized Clinical Trial: Investigating Relationships Between Memory and Sleep. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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. [2020]