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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| URCC U3905 | Other Identifier | University of Rochester | |
| URCC-04-01 | Other Identifier | NCI/DCP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
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.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga Intervention (YOCAS) | Experimental | Standardized Yoga for Cancer Survivors (YOCAS) |
|
| Standard Care Control Condition | Experimental | Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care Control Condition | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-24 months after surgery, chemotherapy, and/or radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen M. Mustian, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States | ||
| CCOP - Wichita |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40421669 | Derived | 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. | |
| 39368335 | Derived | 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. |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga Intervention (YOCAS) | The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. 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. fatigue assessment and management management of therapy complications quality-of-life assessment sleep disorder therapy yoga therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Yoga Intervention (YOCAS) | Procedure | 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. |
|
| Wichita |
| Kansas |
| 67214-3882 |
| United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | 27534-9479 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| 31165647 | Derived | 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. |
| 23940231 | Derived | 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. |
| FG001 | Standard Care Control Condition | The control condition used a standard care format. 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. fatigue assessment and management management of therapy complications quality-of-life assessment |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Yoga Intervention (YOCAS) | The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. 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. fatigue assessment and management management of therapy complications quality-of-life assessment sleep disorder therapy yoga therapy |
| BG001 | Standard Care Control Condition | The control condition used a standard care format. 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. fatigue assessment and management management of therapy complications quality-of-life assessment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Currently employed | Number | participants |
| ||||||||||||||||
| Marital status | Number | participants |
| ||||||||||||||||
| Education | Number | participants |
| ||||||||||||||||
| Cancer type | Number | participants |
| ||||||||||||||||
| Cancer stage | Number | participants |
| ||||||||||||||||
| Previous treatment - Surgery | Number | participants |
| ||||||||||||||||
| Previous Treatment - Chemotherapy | Number | participants |
| ||||||||||||||||
| Previous Treatment - Radiation therapy | Number | participants |
| ||||||||||||||||
| Previous Treatment - Hormone treatment | Number | participants |
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| Current hormone therapy | Number | participants |
| ||||||||||||||||
| Time since first treatment for cancer | Mean | Standard Deviation | months |
| |||||||||||||||
| Karnofsky performance status | The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. Essentially as used in oncology, the KPS is a measure of time to death. A higher score is favorable. There are 3 general categories which are broken down into 11 specific criteria. Scale range is from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease). The scale increases in units of 10. | Mean | Standard Deviation | Karnofsky performance scale |
| ||||||||||||||
| Exercise stage of change | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 2-24 months after surgery, chemotherapy, and/or radiation therapy |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga Intervention (YOCAS) | The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. 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. fatigue assessment and management management of therapy complications quality-of-life assessment sleep disorder therapy yoga therapy | 1 | 206 | 0 | 206 | ||
| EG001 | Standard Care Control Condition | The control condition used a standard care format. 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. fatigue assessment and management management of therapy complications quality-of-life assessment | 1 | 204 | 0 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | hosp d/t abd pain |
| |
| Death | Metabolism and nutrition disorders | Systematic Assessment | Dehydration |
|
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles E. Heckler, PhD, MS. Research Assistant Professor | University of Rochester Medical Center | 585-273-1141 | checkler@urmc.rochester.edu |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009369 | Neoplasms |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
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| Male |
|
| African American |
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| Other |
|
| No |
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| Divorced or separated |
|
| Single |
|
| Widowed |
|
| Unknown |
|
| Completed < 4 years of college |
|
| High school graduate |
|
| Less than a high school graduate |
|
| Unknown |
|
| Hematologic |
|
| Gynecologic |
|
| Alimentary |
|
| Other |
|
| I |
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| II |
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| III |
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| IV |
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| Unknown |
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| No |
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| No |
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| No |
|
| No |
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| Unknown |
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| Not exercising but intend to in next 6 mo |
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| Not exercising but intend to begin in next 30 days |
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| Exercising and have been for less than 6 months |
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| Exercising and have been for more than 6 months |
|
| Unknown |
|
The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group. |
| No |
| Superiority or Other |