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Active Not RecruitingNCT04458194

Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

A Feasibility Trial Comparing the Effectiveness of Virtual YOCAS©® Yoga to Standard Care for Treating Insomnia in Cancer Survivors

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
42 (estimated)
Sponsor
University of Rochester · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: To compare the effects of virtual YOCAS©® intervention to standard care on changes in insomnia measured via the Insomnia Severity Index among cancer survivors SECONDARY OBJECTIVE: To compare the effects of virtual YOCAS©® intervention to standard care on changes in sleep quality measured via the Pittsburgh Sleep Quality Index among cancer survivors OUTLINE: Cancer survivors are randomized to 1 of 2 arms. ARM I: Standard Care: Cancer survivors receive their standard care ARM II: YOCAS©® intervention: Cancer survivors participate in 8 virtual YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via the electronic platform (e.g., Zoom)

Conditions

Interventions

TypeNameDescription
OTHERStandard CareStandard Care is used as a control condition. Cancer survivors assigned to this arm continue to receive standard care from their medical providers.
BEHAVIORALYOCAS©® yogaYoga for Cancer Survivors, YOCAS©®, intervention is a low to moderate intensity mode of exercise that draws from two basic types of yoga; gentle Hatha and Restorative yoga. The program includes specific physical postures and mindfulness exercises focused on breathing and meditation. Cancer survivors will participate in 8 virtual YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)

Timeline

Start date
2022-01-12
Primary completion
2025-11-30
Completion
2026-11-30
First posted
2020-07-07
Last updated
2026-04-16

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04458194. Inclusion in this directory is not an endorsement.