YOCAS: Yoga in Treating Sleep Disturbance in Cancer Survivors

• Sponsor: Gary Morrow (Other)
• Overall Status: Completed
• CT.gov ID: NCT00397930
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 410
• Locations: 11
• Arms: 2
• Duration (Months): 80
• Patients Per Site: 37.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue; Cancer; Sleep Disorders	Procedure: Standard Care Control Condition; Procedure: Yoga Intervention (YOCAS)	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 410 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Yoga for Persistent Sleep Disturbance in Cancer Survivors
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Central Illinois	Decatur	Illinois	United States	62526
2	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
3	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
4	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
5	CCOP - Kansas City	Kansas City	Missouri	United States	64131
6	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
7	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina	United States	27534-9479
8	CCOP - Columbus	Columbus	Ohio	United States	43215
9	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
10	CCOP - Greenville	Greenville	South Carolina	United States	29615
11	CCOP - Northwest	Tacoma	Washington	United States	98405-0986

Sponsors and Collaborators

• Gary Morrow
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Karen M. Mustian, PhD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

None provided.

• Responsible Party: Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base
• ClinicalTrials.gov Identifier: NCT00397930
• Other Study ID Numbers: CDR0000515123; U10CA037420; URCC U3905; URCC-04-01
• First Posted: Nov 10, 2006
• Last Update Posted: Feb 20, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base: cancer-related sleep disturbance; fatigue; sleep disorders
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias; Fatigue

Study Results

Participant Flow

Arm/Group Title	Yoga Intervention (YOCAS)	Standard Care Control Condition
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	206	204
COMPLETED	168	153
NOT COMPLETED	38	51

Baseline Characteristics

Arm/Group Title	Yoga Intervention (YOCAS)	Standard Care Control Condition	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	206	204	410
Age, Customized (years) [Mean (Standard Deviation) ]
Age	54.3 (11.05)	54 (9.57)	54.1 (10.33)
Gender (Count of Participants)
Female	197 95.6%	196 96.1%	393 95.9%
Male	9 4.4%	8 3.9%	17 4.1%
Race/Ethnicity, Customized (participants) [Number]
White	197 95.6%	186 91.2%	383 93.4%
African American	8 3.9%	16 7.8%	24 5.9%
Other	1 0.5%	2 1%	3 0.7%
Region of Enrollment (participants) [Number]
United States	206 100%	204 100%	410 100%
Currently employed (participants) [Number]
Yes	168 81.6%	155 76%	323 78.8%
No	38 18.4%	49 24%	87 21.2%
Marital status (participants) [Number]
Married or long-term committed relationship	145 70.4%	143 70.1%	288 70.2%
Divorced or separated	28 13.6%	32 15.7%	60 14.6%
Single	18 8.7%	17 8.3%	35 8.5%
Widowed	6 2.9%	12 5.9%	18 4.4%
Unknown	9 4.4%	0 0%	9 2.2%
Education (participants) [Number]
Completed 4 years of college or more	96 46.6%	93 45.6%	189 46.1%
Completed < 4 years of college	72 35%	69 33.8%	141 34.4%
High school graduate	33 16%	36 17.6%	69 16.8%
Less than a high school graduate	2 1%	1 0.5%	3 0.7%
Unknown	3 1.5%	5 2.5%	8 2%
Cancer type (participants) [Number]
Breast	152 73.8%	157 77%	309 75.4%
Hematologic	16 7.8%	14 6.9%	30 7.3%
Gynecologic	11 5.3%	8 3.9%	19 4.6%
Alimentary	7 3.4%	17 8.3%	24 5.9%
Other	20 9.7%	8 3.9%	28 6.8%
Cancer stage (participants) [Number]
0	11 5.3%	10 4.9%	21 5.1%
I	66 32%	79 38.7%	145 35.4%
II	71 34.5%	66 32.4%	137 33.4%
III	32 15.5%	32 15.7%	64 15.6%
IV	7 3.4%	4 2%	11 2.7%
Unknown	19 9.2%	13 6.4%	32 7.8%
Previous treatment - Surgery (participants) [Number]
Yes	183 88.8%	181 88.7%	364 88.8%
No	23 11.2%	23 11.3%	46 11.2%
Previous Treatment - Chemotherapy (participants) [Number]
Yes	145 70.4%	139 68.1%	284 69.3%
No	61 29.6%	65 31.9%	126 30.7%
Previous Treatment - Radiation therapy (participants) [Number]
Yes	137 66.5%	129 63.2%	266 64.9%
No	69 33.5%	75 36.8%	144 35.1%
Previous Treatment - Hormone treatment (participants) [Number]
Yes	13 6.3%	15 7.4%	28 6.8%
No	193 93.7%	189 92.6%	382 93.2%
Current hormone therapy (participants) [Number]
Yes	99 48.1%	107 52.5%	206 50.2%
Unknown	107 51.9%	97 47.5%	204 49.8%
Time since first treatment for cancer (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	14.9 (7.18)	17.7 (23.00)	16.3 (17.00)
Karnofsky performance status (Karnofsky performance scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Karnofsky performance scale]	86.9 (33.15)	87.8 (32.00)	87.4 (32.6)
Exercise stage of change (participants) [Number]
Not exercising and do not intend to in next 6 mo	8 3.9%	10 4.9%	18 4.4%
Not exercising but intend to in next 6 mo	43 20.9%	38 18.6%	81 19.8%
Not exercising but intend to begin in next 30 days	45 21.8%	50 24.5%	95 23.2%
Exercising and have been for less than 6 months	44 21.4%	43 21.1%	87 21.2%
Exercising and have been for more than 6 months	62 30.1%	58 28.4%	120 29.3%
Unknown	4 1.9%	5 2.5%	9 2.2%

Outcome Measures

1. Primary Outcome

Title	Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
Description	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.
Time Frame	2-24 months after surgery, chemotherapy, and/or radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yoga Intervention (YOCAS)	Standard Care Control Condition
Arm/Group Description	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	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
Measure Participants	168	153
Mean (Standard Error) [units on a scale]	-1.96 (0.25)	-1.07 (0.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yoga Intervention (YOCAS), Standard Care Control Condition
	Comments	H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level. Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	Between-group differences are expressed as differences in mean Post-Pre change for the global sleep quality PSQI score.
	Method	ANCOVA
	Comments	ANCOVA with post-intervention PSQI score as the outcome, with Group as the factor, and pre-intervention PSQI score as the covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.30
	Estimation Comments	The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group.

Adverse Events

Arm/Group Title	Yoga Intervention (YOCAS)		Standard Care Control Condition
Arm/Group Description	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		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
All Cause Mortality
	Yoga Intervention (YOCAS)		Standard Care Control Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Yoga Intervention (YOCAS)		Standard Care Control Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/206 (0.5%)		1/204 (0.5%)
General disorders
Death	1/206 (0.5%)		0/204 (0%)
Metabolism and nutrition disorders
Death	0/206 (0%)		1/204 (0.5%)
Other (Not Including Serious) Adverse Events
	Yoga Intervention (YOCAS)		Standard Care Control Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/206 (0%)		0/204 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.