Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

Not Applicable

Active, not recruiting

• Conditions: Insomnia
• Interventions: Other: Standard Care; Behavioral: YOCAS©® yoga

• Registration Number: NCT04458194
• Lead Sponsor: University of Rochester

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)

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2022-01-12
• Primary Completion: 2023-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Cancer survivors receive their standard care
YOCAS	YOCAS©® yoga	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)

Primary Outcome Measures

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

Name	Time	Method
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	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

Trial Locations

Locations (2)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Bassett Research Institute; 🇺🇸 Cooperstown, New York, United States