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Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Care
YOCAS©® yoga
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bassett Research InstituteRecruiting
  • University of Rochester Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

YOCAS

Arm Description

Cancer survivors receive their standard care

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)

Outcomes

Primary Outcome Measures

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

Mean Change in sleep quality as measured by the Pittsburgh Sleep Quality Inventory (PSQI) total Score comparing cancer survivors in YOCAS vs. Standard Care
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

Full Information

First Posted
June 30, 2020
Last Updated
July 18, 2023
Sponsor
University of Rochester
Collaborators
Bassett Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04458194
Brief Title
Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors
Official Title
A Feasibility Trial Comparing the Effectiveness of Virtual YOCAS©® Yoga to Standard Care for Treating Insomnia in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Bassett Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Cancer survivors receive their standard care
Arm Title
YOCAS
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
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
Behavioral
Intervention Name(s)
YOCAS©® yoga
Intervention Description
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 Outcome Measure Information:
Title
Mean change in insomnia as measured by the Insomnia Severity Index (ISI) total score comparing cancer survivors in YOCAS vs. Standard Care
Description
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
Time Frame
baseline to week 5
Secondary Outcome Measure Information:
Title
Mean Change in sleep quality as measured by the Pittsburgh Sleep Quality Inventory (PSQI) total Score comparing cancer survivors in YOCAS vs. Standard Care
Description
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
Time Frame
baseline to week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany LaVaute, MS
Phone
585-276-4059
Email
Brittany_LaVaute@URMC.Rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Ju Lin, PhD, MPH
Phone
585-276-6001
Email
po-ju_lin@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Mustian, PhD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bassett Research Institute
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melinda Robinson
Phone
607-547-6707
Email
melinda.robinson@bassett.org
First Name & Middle Initial & Last Name & Degree
Kristin Pullyblank, RN, MS
Phone
607-547-6711
Email
kristin.pullyblank@bassett.org
First Name & Middle Initial & Last Name & Degree
Wendy Brunner, PhD
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany LaVaute, MS
Phone
585-276-4059
Email
Brittany_LaVaute@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Karen Mustian, PhD, MPH

12. IPD Sharing Statement

Learn more about this trial

Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors

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