- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613364
Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors (YOCAS-II)
A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Hawaii MU NCORP
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Illinois
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Decatur, Illinois, United States, 62526
- Heartland NCORP
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Kansas
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Wichita, Kansas, United States, 67214
- Wichita NCORP
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Gulf South MU-NCORP
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Michigan
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Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium NCORP
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Grand Rapids, Michigan, United States, 49503
- Cancer Research Consortium of West Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55426
- Metro-Minnesota NCORP
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Nevada
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Las Vegas, Nevada, United States, 89106
- Nevada Cancer Research Foundation NCORP
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New York
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Rochester, New York, United States, 14642
- University of Rochester NCORP Research Base
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North Carolina
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Winston-Salem, North Carolina, United States, 27104
- Southeast Clinical Oncology Research Consortium
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Ohio
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Columbus, Ohio, United States, 43215
- Columbus NCORP
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Dayton, Ohio, United States, 45420
- Dayton Clinical Oncology Program
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Oregon
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Portland, Oregon, United States, 97213
- Pacific Cancer Research Consortium NCORP
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Health System NCORP
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Wisconsin NCORP
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Milwaukee, Wisconsin, United States, 53226
- Aurora NCORP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Correlative studies
Ancillary studies
Other Names:
Undergo yoga intervention
Other Names:
Correlative studies
Other Names:
|
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.
|
Correlative studies
Ancillary studies
Other Names:
Correlative studies
Other Names:
Undergo CBT-I intervention
|
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."
|
Correlative studies
Ancillary studies
Other Names:
Receive health education
Other Names:
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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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.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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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.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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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)
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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.
|
Baseline up to post intervention (approximately 4 to 8 weeks)
|
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.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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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.
|
Baseline up to post intervention (approximately 4 to 8 weeks)
|
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.
|
Baseline up to post intervention (approximately 4 to 8 weeks)
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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.
|
Baseline up to post intervention (approximately 4 to 8 weeks)
|
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.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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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.
|
Baseline up to post intervention (approximately 4 to 8 weeks)
|
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.
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Baseline up to post intervention (approximately 4 to 8 weeks)
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Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)
Time Frame: Baseline to 3 months
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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.
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Baseline to 3 months
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Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)
Time Frame: Baseline to 3 months
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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.
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Baseline to 3 months
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Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)
Time Frame: Baseline to 6 months
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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.
|
Baseline to 6 months
|
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.
|
Baseline to 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karen Mustian, University of Rochester NCORP Research Base
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URCC14040 (Other Identifier: University of Rochester NCORP Research Base)
- UG1CA189961 (U.S. NIH Grant/Contract)
- NCI-2015-01144 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- RSRB052271 (Other Identifier: University of Rochester)
- URCC-14040 (Other Identifier: CTEP)
- R01CA181064 (U.S. NIH Grant/Contract)
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