Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

NCT ID: NCT04458194

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2026-11-30

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.

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

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Standard Care

Cancer survivors receive their standard care

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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

YOCAS

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 Type: EXPERIMENTAL

YOCAS©® yoga

Intervention Type: 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)

Interventions

Standard Care

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

Intervention Type: OTHER

YOCAS©® yoga

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bassett Medical Center

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Karen Mustian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Mustian, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Bassett Research Institute

Cooperstown, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

STUDY00004405

Identifier Type: -

Identifier Source: org_study_id