FatiguePhase 2YOCASNCT00397930

Yoga in Treating Sleep Disturbance in Cancer Survivors

A Phase 2 study testing Yoga Intervention (YOCAS) in people with Fatigue and Cancer, run by Gary Morrow at 11 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

RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors. PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors. Read more about this study

Who is it for?: Ages 21 to 120 years
Conditions the study is for: Fatigue, Cancer, Sleep Disorders
What is being tested?: Yoga Intervention (YOCAS)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 410 participants
Where: 11 sitesUnited States
Study dates: Oct 2006to Jun 2013
Phase: Phase 2
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 21 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of any type of cancer
More than 1 primary cancer allowed
Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
Able to read English
21 years of age or older

Who cannot join

No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
No diagnosis of sleep apnea
No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
No metastatic cancer

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

CCOP - Columbus
Columbus, Ohio, 43215
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Wichita
Wichita, Kansas, 67214-3882

Other trials in United States

About this study

Official title: Yoga for Persistent Sleep Disturbance in Cancer Survivors

RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.

Read the detailed description

OBJECTIVES:

Primary

Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2 arms.

Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion.
Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Conditions: Fatigue, Cancer, Sleep Disorders
Being tested: Standard Care Control Condition, Yoga Intervention (YOCAS)
Keywords: cancer-related sleep disturbance, fatigue, sleep disorders
Medical subject headings: Fatigue, Neoplasms, Sleep Wake Disorders

What participants receive

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

Standard Care Control ConditionProcedure or surgery
Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.
Yoga Intervention (YOCAS)Procedure or surgery
The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.

Study groups in NCT00397930
Study group	Role	What they receive
Yoga Intervention (YOCAS)	Experimental	Standardized Yoga for Cancer Survivors (YOCAS) Receives: Procedure: Yoga Intervention (YOCAS)
Standard Care Control Condition	Experimental	Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Receives: Procedure: Standard Care Control Condition

What is being measured

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

Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.
PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.
Measured: 2-24 months after surgery, chemotherapy, and/or radiation therapy

Timeline

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

Oct 2006Jun 2013

First posted10 Nov 2006 (estimated)
Study startOct 2006
Primary completionApr 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for FatigueStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 410 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00397930
Sponsor's protocol ID: CDR0000515123
Other IDs: U10CA037420, URCC U3905, URCC-04-01
Acronym: YOCAS
Status last verified: Jan 2017
First submitted: 9 Nov 2006
Last updated: 20 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.
PubMed 40421669
Arana-Chicas E, Lin PJ, Gada U, Sun H, Chakrabarti A, Mattick LJ, Rieth K, Chay CH, Ruzich J, Esparaz BT, Cupertino AP, Altman BJ, Vertino PM, Mohile SG, Mustian KM. The effect of YOCAS(c)(R) yoga on cancer-related fatigue and quality of life in older (60+) vs. younger (</= 59) cancer survivors: Secondary analysis of a nationwide, multicenter, phase 3 randomized controlled trial. J Geriatr Oncol. 2024 Nov;15(8):102076. doi: 10.1016/j.jgo.2024.102076. Epub 2024 Oct 4.
PubMed 39368335
Lin PJ, Kleckner IR, Loh KP, Inglis JE, Peppone LJ, Janelsins MC, Kamen CS, Heckler CE, Culakova E, Pigeon WR, Reddy PS, Messino MJ, Gaur R, Mustian KM. Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419855134. doi: 10.1177/1534735419855134.
PubMed 31165647
Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Palesh OG, Chandwani K, Reddy PS, Melnik MK, Heckler C, Morrow GR. Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. J Clin Oncol. 2013 Sep 10;31(26):3233-41. doi: 10.1200/JCO.2012.43.7707. Epub 2013 Aug 12.
PubMed 23940231

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Yoga for Persistent Sleep Disturbance in Cancer Survivors
ClinicalTrials.gov ID: NCT00397930
Acronym / sponsor ID: YOCAS / CDR0000515123
Conditions: Fatigue, Cancer, Sleep Disorders
Keywords: cancer-related sleep disturbance, fatigue, sleep disorders
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 410 participants (actual)
Lead sponsor: Gary MorrowUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Oct 2006
Primary completion: Apr 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 10 Nov 2006 (estimated)
Results: Posted 17 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.

Detailed description

OBJECTIVES:

Primary

Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.

Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion.
Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Yoga Intervention (YOCAS)	Experimental	Procedure: Yoga Intervention (YOCAS)Standardized Yoga for Cancer Survivors (YOCAS)
Standard Care Control Condition	Experimental	Procedure: Standard Care Control ConditionStandard follow-up care provided by their treating oncologists as appropriate for individual diagnoses.

Who may qualify

Ages: 21 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of any type of cancer
More than 1 primary cancer allowed
Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)

Key exclusion criteria (4 listed)

No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
No diagnosis of sleep apnea
No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
No metastatic cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard Care Control ConditionCancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.	Procedure or surgery	Standard Care Control Condition
Yoga Intervention (YOCAS)The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.	Procedure or surgery	Yoga Intervention (YOCAS)

Primary outcome

Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
Time frame: 2-24 months after surgery, chemotherapy, and/or radiation therapy
Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.

Results and safety

Results posted to the registry on 17 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Yoga Intervention (YOCAS)	206	168
Standard Care Control Condition	204	153

Primary outcome: Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)

Time frame: 2-24 months after surgery, chemotherapy, and/or radiation therapy. Mean (Standard Error). Unit: units on a scale

Measure	Yoga Intervention (YOCAS) n = 168	Standard Care Control Condition n = 153
Value	-1.96 (0.25)	-1.07 (0.23)

Yoga Intervention (YOCAS) vs Standard Care Control Condition: Mean Difference (Final Values): -0.79, p = 0.009, ANCOVA

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Yoga Intervention (YOCAS)	1 of 206 (0.5%)	0 of 206 (0%)	Not reported
Standard Care Control Condition	1 of 204 (0.5%)	0 of 204 (0%)	Not reported

Limitations and caveats (from the sponsor): The study did not account for components such as time or attention, as this would have required the use of a placebo yoga intervention for the YOCAS program. The results are not generalizable for all yoga types, nor for all socioeconomic backgrounds.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40421669Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.
Derived from this study: PubMed 39368335Arana-Chicas E, Lin PJ, Gada U, Sun H, Chakrabarti A, Mattick LJ, Rieth K, Chay CH, Ruzich J, Esparaz BT, Cupertino AP, Altman BJ, Vertino PM, Mohile SG, Mustian KM. The effect of YOCAS(c)(R) yoga on cancer-related fatigue and quality of life in older (60+) vs. younger (</= 59) cancer survivors: Secondary analysis of a nationwide, multicenter, phase 3 randomized controlled trial. J Geriatr Oncol. 2024 Nov;15(8):102076. doi: 10.1016/j.jgo.2024.102076. Epub 2024 Oct 4.
Derived from this study: PubMed 31165647Lin PJ, Kleckner IR, Loh KP, Inglis JE, Peppone LJ, Janelsins MC, Kamen CS, Heckler CE, Culakova E, Pigeon WR, Reddy PS, Messino MJ, Gaur R, Mustian KM. Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419855134. doi: 10.1177/1534735419855134.
Derived from this study: PubMed 23940231Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Palesh OG, Chandwani K, Reddy PS, Melnik MK, Heckler C, Morrow GR. Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. J Clin Oncol. 2013 Sep 10;31(26):3233-41. doi: 10.1200/JCO.2012.43.7707. Epub 2013 Aug 12.
Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen M. Mustian, PhD principal investigator

University of Rochester

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Yoga Intervention (YOCAS) in people with Fatigue and Cancer, run by Gary Morrow at 11 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 7 inclusion and 4 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 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). 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 Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) (time frame: 2-24 months after surgery, chemotherapy, and/or radiation therapy). 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 NCT00397930, which also lists 4 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 20 Feb 2017.