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

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ClinicalTrials.gov Identifier: NCT02613364
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, 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.

TERTIARY OBJECTIVES:

I. To explore whether YOCAS is effective for improving circadian activity rhythms (24 and 12 hour amplitudes and acrophases measured via actigraphy), physical function (i.e., cardiopulmonary [6-minute (min.) walk] and muscular function [dynamometry]), and inflammation (interleukin [IL]-6, IL-8, IL-10, IL-1beta, interferon [IFN]-gamma, & tumor necrosis factor receptor [TNFR]1 via standardized enzyme-linked immunosorbent assay [ELISA]s) compared to CBT-I and a health education control.

II. To explore whether changes in circadian activity rhythms, physical function and inflammation mediate the effect of YOCAS on insomnia.

III. To explore the time-varying nature of physical activity behavior after cancer treatment and develop a new methodological approach to jointly model longitudinally measured exposures and outcomes subject to measurement error and modification by personal characteristics in a physical activity intervention study.

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 study, patients are followed up at 3 and 6 months.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 741 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2021

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. Difference in mean change on the Insomnia Severity Index (ISI) between YOCAS and CBT-I [ Time Frame: Baseline to up to 6 months following completion of intervention ]
    A linear mixed effects analysis of covariance (ANCOVA) will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. Performed at the two-tailed 5% level of significance. The mean difference between groups with associated 95% confidence intervals will be estimated using the appropriate contrasts.

  2. Difference in mean change on the ISI between YOCAS and health education [ Time Frame: Baseline to up to 6 months following completion of intervention ]
    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 mean difference between groups with associated 95% confidence intervals will be estimated using the appropriate contrasts.


Secondary Outcome Measures :
  1. Improvement in global sleep quality impairment (Pittsburgh Sleep Quality Inventory total) [ Time Frame: Baseline to up to 6 months following completion of intervention ]
    A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS compared to CBT-I and health education. The mean difference between groups with associated 95% confidence intervals will be estimated using the appropriate contrasts.

  2. Improvement in insomnia, as measured by actigraphy [ Time Frame: Baseline to 6 months post-intervention ]
    A longitudinal analysis using the ISI total score at all five time points as the response will be performed. The fixed effects will be Time, Group (all three in this analysis), and Time by Group interaction. Within-subject random effects will initially be modeled assuming an unstructured covariance matrix, but will be simplified after inspection of the estimated covariance structure (e.g., compound symmetry). Fixed effects will be tested using F tests with the Kenward-Roger degrees of freedom adjustment. Impact of group on time trajectory of insomnia will be tested via Time*Group interaction.

  3. Improvement in insomnia, as measured via actigraphy [ Time Frame: Baseline to 3 months post-intervention ]
    A longitudinal analysis using the ISI total score at all five time points as the response will be performed. The fixed effects will be Time, Group (all three in this analysis), and Time by Group interaction. Within-subject random effects will initially be modeled assuming an unstructured covariance matrix, but will be simplified after inspection of the estimated covariance structure (e.g., compound symmetry). Fixed effects will be tested using F tests with the Kenward-Roger degrees of freedom adjustment. Impact of group on time trajectory of insomnia will be tested via Time*Group interaction.

  4. Improvement in objective symptoms of insomnia (sleep latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via actigraphy) [ Time Frame: Baseline to up to 6 months following completion of intervention ]
    A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS compared to CBT-I and health education. The mean difference between groups with associated 95% confidence intervals will be estimated using the appropriate contrasts.


Other Outcome Measures:
  1. Improvement in circadian activity rhythms (24 and 12 hour amplitudes and acrophases via actigraphy) [ Time Frame: Baseline to 6 months post-intervention ]
    Changes in the estimated parameters of the two-oscillator (12 and 24 hours) cosinor model and the Hill function model analyzed using ANCOVA. These parameters include Mesor (M), Amplitude (A1) and Acrophase (Phi1) for the 24-hour oscillator and Amplitude (A2) and Acrophase (Phi2) for the 12-hour oscillator. Estimates will be from the log-transformed activity counts using nonlinear regression. Degree of rhythmicity will be assessed with the Fisher-transformed model multiple correlation.

  2. Improvement in inflammation (IL-6, IL-8, IL-10, IL-1beta, IFN-gamma, & TNFR1 via standardized ELISAs and multiplexes) [ Time Frame: Baseline to 6 months post-intervention ]
    Changes in the estimated parameters of the two-oscillator (12 and 24 hours) cosinor model and the Hill function model analyzed using ANCOVA. These parameters include M, A1 and Phi1 for the 24-hour oscillator and A2 and Phi2 for the 12-hour oscillator. Estimates will be from the log-transformed activity counts using nonlinear regression. Degree of rhythmicity will be assessed with the Fisher-transformed model multiple correlation. Inflammatory biomarkers will be log-transformed as needed.

  3. Improvement in physical function (i.e., cardiopulmonary [6-min. walk] and muscular function [dynamometry]) [ Time Frame: Baseline to 6 months post-intervention ]
    Changes in the estimated parameters of the two-oscillator (12 and 24 hours) cosinor model and the Hill function model analyzed using ANCOVA. These parameters include M, A1 and Phi1 for the 24-hour oscillator and A2 and Phi2 for the 12-hour oscillator. Estimates will be from the log-transformed activity counts using nonlinear regression. Degree of rhythmicity will be assessed with the Fisher-transformed model multiple correlation.

  4. Mediated effect of YOCAS on insomnia [ Time Frame: Baseline to 6 months post-intervention ]
    To explore whether changes in physical function, circadian rhythm and inflammation mediate the effect of YOCAS on insomnia, separate mediation analyses performed on pre-post ISI change scores (CS) and the above outcomes will be used as potential mediators. Path analysis will be used, where the intervention affects CS, the intervention affects the mediator, and the mediator, in turn, affects the CS. Structural equation modeling will be used. Mediation will be assessed via indirect effect estimation using bootstrap-based 95% confidence intervals.



Information from the National Library of Medicine

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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
Gary Morrow
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen Mustian University of Rochester NCORP Research Base

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Responsible Party: Gary Morrow, Director, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT02613364     History of Changes
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
Last Update Posted: May 10, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Neoplasms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders