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Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors (YOCAS-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02613364
Recruitment Status : Completed
First Posted : November 24, 2015
Results First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Karen Mustian, University of Rochester NCORP Research Base

Brief Summary:
This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.

Condition or disease Intervention/treatment Phase
Cancer Survivor Insomnia Malignant Neoplasm Behavioral: Behavioral Intervention Other: Cognitive Intervention Other: Educational Intervention Other: Laboratory Biomarker Analysis Device: Monitoring Device Other: Quality-of-Life Assessment Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if Yoga for Cancer Survivors (YOCAS) is effective for improving patient-reported insomnia (Insomnia Severity Index) compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) and a health education control immediately post intervention.

SECONDARY OBJECTIVES:

I. To examine if YOCAS is effective for improving objective symptoms of insomnia (sleep latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via actigraphy) and global sleep quality impairment (Pittsburgh Sleep Quality Index) compared to CBT-I and a health education control.

II. To examine if YOCAS and CBT-I are effective for maintaining improvements in insomnia (Insomnia Severity Index) 3 and 6 months post intervention compared to a health education control.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.

ARM II: Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.

ARM III: Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."

After completion of intervention, patients are followed up at 3 and 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 746 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors
Actual Study Start Date : May 6, 2016
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (behavioral intervention-yoga)
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral: Behavioral Intervention
Undergo yoga intervention
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • BEHAVIORAL THERAPY
  • Behavioral Treatment
  • Behavioral Treatments

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Correlative studies
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Experimental: Arm II (cognitive intervention-CBT-I)
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Other: Cognitive Intervention
Undergo CBT-I intervention

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Correlative studies
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Active Comparator: Arm III (educational intervention)
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
Other: Educational Intervention
Receive health education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Correlative studies
Other Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. Mean Change in the ISI Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    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. Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15.

  2. Mean Change in the ISI Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    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 between YOCAS and health education.


Secondary Outcome Measures :
  1. Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    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 between YOCAS and health education.

  2. Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    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 between YOCAS and CBT-I.

  3. Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.

  4. Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.

  5. Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of the log base 10 of the original measurement was used for the analysis.

  6. Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of log base 10 of the original measurement was used for the analysis.

  7. Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.

  8. Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.

  9. Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of log base 10 of the (measurement + 1) was used in the analysis.

  10. Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of the log base 10 of the (measure + 1) was used in the analysis.

  11. Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) [ Time Frame: Baseline to 3 months ]
    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 between YOCAS and health education.

  12. Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) [ Time Frame: Baseline to 3 months ]
    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 between YOCAS and CBT-I.

  13. Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) [ Time Frame: Baseline to 6 months ]
    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 between YOCAS and health education.

  14. Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) [ Time Frame: Baseline to 6 months ]
    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 between YOCAS and CBT-I.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 2-60 months
  • Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index
  • Be able to read and understand English
  • Be able to provide written informed consent

Exclusion Criteria:

  • Have contraindications to functional testing or yoga participation according to the treating physician
  • Have practiced yoga >= 1 day a week 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613364


Locations
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United States, Hawaii
Hawaii MU NCORP
Honolulu, Hawaii, United States, 96813
United States, Illinois
Heartland NCORP
Decatur, Illinois, United States, 62526
United States, Kansas
Wichita NCORP
Wichita, Kansas, United States, 67214
United States, Louisiana
Gulf South MU-NCORP
New Orleans, Louisiana, United States, 70112
United States, Michigan
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Metro-Minnesota NCORP
Minneapolis, Minnesota, United States, 55426
United States, Nevada
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States, 89106
United States, New York
University of Rochester NCORP Research Base
Rochester, New York, United States, 14642
United States, North Carolina
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Columbus NCORP
Columbus, Ohio, United States, 43215
Dayton Clinical Oncology Program
Dayton, Ohio, United States, 45420
United States, Oregon
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States, 97213
United States, South Carolina
Greenville Health System NCORP
Greenville, South Carolina, United States, 29605
United States, Wisconsin
Wisconsin NCORP
Marshfield, Wisconsin, United States, 54449
Aurora NCORP
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Karen Mustian University of Rochester NCORP Research Base
  Study Documents (Full-Text)

Documents provided by Karen Mustian, University of Rochester NCORP Research Base:
Layout table for additonal information
Responsible Party: Karen Mustian, Professor, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT02613364    
Other Study ID Numbers: URCC14040
NCI-2015-01144 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RSRB052271 ( Other Identifier: University of Rochester )
URCC14040 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-14040 ( Other Identifier: DCP )
URCC-14040 ( Other Identifier: CTEP )
R01CA181064 ( U.S. NIH Grant/Contract )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2015    Key Record Dates
Results First Posted: March 23, 2021
Last Update Posted: March 23, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Neoplasms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders