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Cancer SurvivorYOCAS-IINCT02613364

Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors

A study testing Behavioral Intervention, Cognitive Intervention and Educational Intervention in people with Cancer Survivor and Insomnia, run by University of Rochester NCORP Research Base at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Survivor, Insomnia, Malignant Neoplasm
What is being tested?
Behavioral Intervention, Cognitive Intervention and Educational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
746 participants
Where
16 sitesUnited States
Study dates
31 Aug 2016to 4 Feb 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Columbus NCORP

    Columbus, Ohio, 43215

  • Dayton Clinical Oncology Program

    Dayton, Ohio, 45420

  • Heartland NCORP

    Decatur, Illinois, 62526

  • Cancer Research Consortium of West Michigan

    Grand Rapids, Michigan, 49503

  • Greenville Health System NCORP

    Greenville, South Carolina, 29605

  • Hawaii MU NCORP

    Honolulu, Hawaii, 96813

  • Nevada Cancer Research Foundation NCORP

    Las Vegas, Nevada, 89106

  • Wisconsin NCORP

    Marshfield, Wisconsin, 54449

  • Aurora NCORP

    Milwaukee, Wisconsin, 53226

  • Metro-Minnesota NCORP

    Minneapolis, Minnesota, 55426

  • Gulf South MU-NCORP

    New Orleans, Louisiana, 70112

  • Pacific Cancer Research Consortium Ncorp

    Portland, Oregon, 97213

  • University of Rochester NCORP Research Base

    Rochester, New York, 14642

  • Wichita NCORP

    Wichita, Kansas, 67214

  • Southeast Clinical Oncology Research Consortium

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Behavioral Intervention, Cognitive Intervention, Educational Intervention, Laboratory Biomarker Analysis, Monitoring Device
Medical subject headings
Sleep Initiation and Maintenance Disorders, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral InterventionBehavioural

    Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy

    Undergo yoga intervention

  • Cognitive InterventionOther

    Undergo CBT-I intervention

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive health education

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Monitoring DeviceDevice

    Also called Monitor

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02613364
Study groupRoleWhat they receive
Arm I (behavioral intervention-yoga)ExperimentalPatients 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.
Receives: Behavioral: Behavioral Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment
Arm II (cognitive intervention-CBT-I)ExperimentalPatients 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.
Receives: Other: Cognitive Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment
Arm III (educational intervention)Active comparatorPatients 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."
Receives: Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in the ISI Comparing YOCAS vs. CBT-I

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  2. Mean Change in the ISI Comparing YOCAS vs. Health Education

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

Secondary outcomes (14)

  1. Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  2. Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  3. Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  4. Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  5. Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  6. Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  7. Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  8. Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  9. Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  10. Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I

    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.

    Measured: Baseline up to post intervention (approximately 4 to 8 weeks)

  11. Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)

    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.

    Measured: Baseline to 3 months

  12. Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)

    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.

    Measured: Baseline to 3 months

  13. Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)

    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.

    Measured: Baseline to 6 months

  14. Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month)

    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.

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2015 (estimated)
  2. Study start31 Aug 2016
  3. Primary completion4 Feb 2020
  4. Study completion4 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613364
Sponsor's protocol ID
URCC14040
Other IDs
NCI-2015-01144, RSRB052271, URCC14040, URCC-14040, URCC-14040, R01CA181064, UG1CA189961
Acronym
YOCAS-II
Status last verified
Apr 2024
First submitted
20 Nov 2015
Last updated
1 May 2024
Data monitoring committee
Yes

Publications

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PubMed 41170811

  • Altman BJ, Lin PJ, Mattick LJ, Outland EH, Bautista J, Li CS, Gada U, Morris KM, Knudsen-Clark AM, Mwangi D, DeRollo RE, Kleckner AS, Kleckner IR, Gilmore NJ, Esparaz BT, Curtis A, Conlin A, Monaco G, Hughey JJ, Mustian KM. Blood Clock Correlation Distance (BloodCCD) as a novel marker to detect circadian rhythm disruption in cancer survivors with insomnia. BJC Rep. 2025 Sep 3;3(1):60. doi: 10.1038/s44276-025-00176-9.

    PubMed 40903493

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Intervention, Cognitive Intervention and Educational Intervention in people with Cancer Survivor and Insomnia, run by University of Rochester NCORP Research Base at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in the ISI Comparing YOCAS vs. CBT-I (time frame: Baseline up to post intervention (approximately 4 to 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02613364, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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