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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

Tracking Information
First Submitted Date  ICMJE November 20, 2015
First Posted Date  ICMJE November 24, 2015
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE May 6, 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02613364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 23, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors
Official Title  ICMJE A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer Survivor
  • Insomnia
  • Malignant Neoplasm
Intervention  ICMJE
  • 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: Cognitive Intervention
    Undergo CBT-I intervention
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Behavioral Intervention
    • Other: Laboratory Biomarker Analysis
    • Device: Monitoring Device
    • Other: 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.
    Interventions:
    • Other: Cognitive Intervention
    • Other: Laboratory Biomarker Analysis
    • Device: Monitoring Device
    • Other: 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."
    Interventions:
    • Other: Educational Intervention
    • Other: Laboratory Biomarker Analysis
    • Device: Monitoring Device
    • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 8, 2019)
741
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
630
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02613364
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Morrow, University of Rochester NCORP Research Base
Study Sponsor  ICMJE Gary Morrow
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Karen Mustian University of Rochester NCORP Research Base
PRS Account University of Rochester
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP