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Yoga in Treating Sleep Disturbance in Cancer Survivors (YOCAS)

Primary Purpose

Fatigue, Cancer, Sleep Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard Care Control Condition
Yoga Intervention (YOCAS)
Sponsored by
Gary Morrow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring cancer-related sleep disturbance, fatigue, sleep disorders

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of any type of cancer
  • More than 1 primary cancer allowed
  • Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
  • Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
  • Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
  • Able to read English
  • 21 years of age or older

Exclusion Criteria:

  • No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
  • No diagnosis of sleep apnea
  • No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
  • No metastatic cancer

Sites / Locations

  • CCOP - Central Illinois
  • CCOP - Wichita
  • CCOP - Grand Rapids
  • CCOP - Kalamazoo
  • CCOP - Kansas City
  • CCOP - Hematology-Oncology Associates of Central New York
  • CCOP - Southeast Cancer Control Consortium
  • CCOP - Columbus
  • CCOP - Columbia River Oncology Program
  • CCOP - Greenville
  • CCOP - Northwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yoga Intervention (YOCAS)

Standard Care Control Condition

Arm Description

Standardized Yoga for Cancer Survivors (YOCAS)

Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses.

Outcomes

Primary Outcome Measures

Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2006
Last Updated
January 3, 2017
Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00397930
Brief Title
Yoga in Treating Sleep Disturbance in Cancer Survivors
Acronym
YOCAS
Official Title
Yoga for Persistent Sleep Disturbance in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors. PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
Detailed Description
OBJECTIVES: Primary Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2 arms. Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion. Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Cancer, Sleep Disorders
Keywords
cancer-related sleep disturbance, fatigue, sleep disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Intervention (YOCAS)
Arm Type
Experimental
Arm Description
Standardized Yoga for Cancer Survivors (YOCAS)
Arm Title
Standard Care Control Condition
Arm Type
Experimental
Arm Description
Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses.
Intervention Type
Procedure
Intervention Name(s)
Standard Care Control Condition
Intervention Description
Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
Intervention Type
Procedure
Intervention Name(s)
Yoga Intervention (YOCAS)
Intervention Description
The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
Primary Outcome Measure Information:
Title
Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
Description
Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.
Time Frame
2-24 months after surgery, chemotherapy, and/or radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of any type of cancer More than 1 primary cancer allowed Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance) Able to read English 21 years of age or older Exclusion Criteria: No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months No diagnosis of sleep apnea No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®]) No metastatic cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M. Mustian, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31165647
Citation
Lin PJ, Kleckner IR, Loh KP, Inglis JE, Peppone LJ, Janelsins MC, Kamen CS, Heckler CE, Culakova E, Pigeon WR, Reddy PS, Messino MJ, Gaur R, Mustian KM. Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419855134. doi: 10.1177/1534735419855134.
Results Reference
derived
PubMed Identifier
23940231
Citation
Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Palesh OG, Chandwani K, Reddy PS, Melnik MK, Heckler C, Morrow GR. Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. J Clin Oncol. 2013 Sep 10;31(26):3233-41. doi: 10.1200/JCO.2012.43.7707. Epub 2013 Aug 12.
Results Reference
derived
Links:
URL
https://www.cancer.gov/publications/pdq
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

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Yoga in Treating Sleep Disturbance in Cancer Survivors

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