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Trial record 2 of 19 for:    yoga AND insomnia

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Rochester
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier:
NCT02613364
First received: November 20, 2015
Last updated: June 1, 2016
Last verified: June 2016
  Purpose
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 Intervention 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
Other: Questionnaire Administration
Procedure: Yoga
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Difference in mean change on the ISI between YOCAS and health education [ Time Frame: Baseline to up to 6 months following completion of intervention ] [ Designated as safety issue: No ]
    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:
  • Improvement in global sleep quality impairment (Pittsburgh Sleep Quality Inventory total) [ Time Frame: Baseline to up to 6 months following completion of intervention ] [ Designated as safety issue: No ]
    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.

  • Improvement in insomnia, as measured by actigraphy [ Time Frame: Baseline to 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • Improvement in insomnia, as measured via actigraphy [ Time Frame: Baseline to 3 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Improvement in circadian activity rhythms (24 and 12 hour amplitudes and acrophases via actigraphy) [ Time Frame: Baseline to 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Improvement in physical function (i.e., cardiopulmonary [6-min. walk] and muscular function [dynamometry]) [ Time Frame: Baseline to 6 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • Mediated effect of YOCAS on insomnia [ Time Frame: Baseline to 6 months post-intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 630
Study Start Date: May 2016
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (yoga intervention)
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.
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
Other: Questionnaire Administration
Ancillary studies
Procedure: Yoga
Undergo yoga intervention
Other Name: Yoga Therapy
Experimental: Arm II (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.
Behavioral: Behavioral Intervention
Undergo CBT-I 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: 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
Other: Questionnaire Administration
Ancillary studies
Active Comparator: Arm III (health education)
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: Educational Intervention
Receive health education booklet
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
Other: Questionnaire Administration
Ancillary studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 2-24 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02613364

Locations
United States, Hawaii
Hawaii MU NCORP Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Virginia McMahon    808-586-2979    Virginia@cc.hawaii.edu   
United States, Illinois
Heartland NCORP Recruiting
Decatur, Illinois, United States, 62526
Contact: Peggy Wisher    217-876-6618    pwisher@dmhhs.org   
United States, Kansas
Wichita NCORP Recruiting
Wichita, Kansas, United States, 67214
Contact: Keisha Humphries    316-268-5374    Keisha.Humphries@via-christi.org   
United States, New York
University of Rochester NCORP Research Base Not yet recruiting
Rochester, New York, United States, 14642
Contact: Karen M. Mustian    585-275-5513    Karen_Mustian@urmc.rochester.edu   
Principal Investigator: Karen M. Mustian         
United States, North Carolina
Southeast Clinical Oncology Research Consortium Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Robin Burgess    336-777-3036    rburgess@southeastclinicaloncology.org   
United States, Ohio
Columbus NCORP Recruiting
Columbus, Ohio, United States, 43215
Contact: Julie O'Brien    614-488-3320    julie@columbusccop.org   
Dayton Clinical Oncology Program Recruiting
Dayton, Ohio, United States, 45420
Contact: Mary Ontko    937-775-1350    mary.ontko@wright.edu   
United States, South Carolina
Greenville Health System NCORP Recruiting
Greenville, South Carolina, United States, 29605
Contact: Kim Williams    864-522-2066    kwilliams8@ghs.org   
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen Mustian University of Rochester NCORP Research Base
  More Information

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  RSRB052271  URCC14040  URCC-14040  URCC-14040  R01CA181064  UG1CA189961 
Study First Received: November 20, 2015
Last Updated: June 1, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 07, 2016