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Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994279
First Posted: October 14, 2009
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
Results First Submitted: July 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Depression
Fatigue
Sleep Disorders
Interventions: Behavioral: Yoga
Behavioral: Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from three NCI CCOP sites between 1/2010 and 8/2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Yoga Intervention

Yoga Intervention

Yoga: Yoga sessions

Arm 2: Educational Wellness Group

Educational Wellness Group

Education: Educational Wellness Group


Participant Flow:   Overall Study
    Arm 1: Yoga Intervention   Arm 2: Educational Wellness Group
STARTED   22   18 
COMPLETED   18   13 
NOT COMPLETED   4   5 
Withdrawal by Subject                2                2 
Toxicity                1                0 
Multiple reasons                1                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants

Reporting Groups
  Description
Arm 1: Yoga Intervention

Yoga Intervention

Yoga: Yoga sessions

Arm 2: Educational Wellness Group

Educational Wellness Group

Education: Educational Wellness Group

Total Total of all reporting groups

Baseline Measures
   Arm 1: Yoga Intervention   Arm 2: Educational Wellness Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   18   40 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      19  86.4%      18 100.0%      37  92.5% 
>=65 years      3  13.6%      0   0.0%      3   7.5% 
Age 
[Units: Years]
Median (Full Range)
 50 
 (29 to 83) 
 45 
 (29 to 64) 
 47 
 (29 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22 100.0%      18 100.0%      40 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      22 100.0%      18 100.0%      40 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   9.1%      3  16.7%      5  12.5% 
White      20  90.9%      15  83.3%      35  87.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   22   18   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Retention   [ Time Frame: 10 weeks ]

2.  Secondary:   Fatigue at 10 Weeks   [ Time Frame: 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no limitations.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Doug Case
Organization: Wake Forest NCI NCORP Research Base
phone: (336) 716-1048
e-mail: dcase@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00994279     History of Changes
Other Study ID Numbers: REBACCCWFU97309
U10CA081851 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2009
First Posted: October 14, 2009
Results First Submitted: July 15, 2015
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017