Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

Last updated: November 1, 2024
Sponsor: University of Rochester
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Standard Care

YOCAS©® yoga

Clinical Study ID

NCT04458194
STUDY00004405
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 2months 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

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 thestudy

  • have a confirmed diagnosis of sleep apnea or restless leg syndrome

  • be receiving any form of treatment for cancer with the exception of hormonal orbiologic therapy

  • have distant metastases

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Standard Care
Phase:
Study Start date:
January 12, 2022
Estimated Completion Date:
June 30, 2025

Study 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)

Connect with a study center

  • Bassett Research Institute

    Cooperstown, New York 13326
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

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