Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT04458194
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
A Feasibility Trial Comparing the Effectiveness of Virtual YOCAS©® Yoga to Standard Care for Treating Insomnia in Cancer Survivors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: