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NCT Number: NCT04458194

Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bassett Research Institute, Cooperstown, New York, United States

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

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

    Time frame: baseline to week 5

    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

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

    Time frame: baseline to week 5

    The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. 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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Bassett Medical Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 7, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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