Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

NCT04458194 | Active Not Recruiting

• 1 other identifier: STUDY00004405
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Mean change in insomnia as measured by the Insomnia Severity Index (ISI) total score comparing cancer survivors in YOCAS vs. Standard Care

  The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change among cancer survivors in YOCAS vs. Standard Care

  baseline to week 5

Secondary Outcomes (1)

• Mean Change in sleep quality as measured by the Pittsburgh Sleep Quality Inventory (PSQI) total Score comparing cancer survivors in YOCAS vs. Standard Care

  baseline to week 5

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Cancer survivors receive their standard care

Other: Standard Care

YOCAS

EXPERIMENTAL

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)

Behavioral: YOCAS©® yoga

Interventions

Standard Care OTHER

Standard Care is used as a control condition. Cancer survivors assigned to this arm continue to receive standard care from their medical providers.

Standard Care

YOCAS©® yoga BEHAVIORAL

Yoga 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)

YOCAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer Survivors must:
• have a confirmed diagnosis of cancer
• have received surgery, chemotherapy, and/or radiation therapy
• have completed all surgery, chemotherapy, and/or radiation therapy within the last 2 months to 10 years
• score ≥4 on a 0-10 sleep screening scale
• be at least 18 years of age
• be able to read and understand English
• be able to provide informed consent
• have access to the internet and a smartphone, tablet, and/or computer
• have the ability to attend 8 virtual yoga sessions

You may not qualify if:

• Cancer Survivor must not:
• have contraindications to yoga participation
• have practiced yoga within the 3 months prior to enrolling in the study
• be planning to start yoga on their own during the time they are enrolled in the study
• have a confirmed diagnosis of sleep apnea or restless leg syndrome
• be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
• have distant metastases

Sponsors & Collaborators

• University of Rochester: lead
• Bassett Medical Center: collaborator

Study Sites (2)

Bassett Research Institute

Cooperstown, New York, 13326, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karen Mustian, PhD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: January 12, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (2)