Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors (YogaCares)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wake Forest School of Medicine
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01324102
First received: March 4, 2011
Last updated: May 20, 2015
Last verified: May 2015
Results First Received: December 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms
Intervention: Behavioral: Yoga therapy

  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 identified through cancer registry who were: diagnosed with cancer (any type) Stage 1-4 within the past three years; received surgery, chemotherapy, or radiation treatment; no psychotic or dementing disorders; and not currently in hospice care.

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

Reporting Groups
  Description
Yoga Therapy Intervention

Intervention

Yoga therapy received an 8 week 2x weekly Yoga therapy class.

Wait List Control Wait List control received no intervention for 8 weeks, then joined the yoga group

Participant Flow:   Overall Study
    Yoga Therapy Intervention     Wait List Control  
STARTED     11 [1]   12 [2]
COMPLETED     10     6  
NOT COMPLETED     1     6  
illness                 1                 6  
[1] Yoga groups 3 and 5 (not including pre-randomization group)
[2] Yoga group 4 and 6



  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.
No text entered.

Reporting Groups
  Description
Yoga Therapy Intervention Intervention: Yoga therapy was 8 week class for two times per week
Wait List Control Wait List control: The wait list control did not receive an intervention.
Total Total of all reporting groups

Baseline Measures
    Yoga Therapy Intervention     Wait List Control     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age, Customized [1]
[units: Years]
Mean (Full Range)
     
Mean     69.42  
  (55 to 84)  
  69.42  
  (55 to 84)  
  69.42  
  (55 to 84)  
Gender  
[units: participants]
     
Female     1     0     1  
Male     10     12     22  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     10     11     21  
All other     1     1     2  
[1] Adult individuals of any age were permitted, but since most of those diagnosed with cancer are older, the sample is predominantly older.



  Outcome Measures

1.  Primary:   Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.   [ Time Frame: Primary outcome is measured at baseline and after the 8 week yoga intervention. ]


  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
The goals of this study were modest. A small pilot pre-post randomized trial was completed with a Yoga therapy intervention and a Wait list intervention. Additional studies in larger samples are needed.


  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: Jennifer Moye
Organization: VA Boston Healthcare System
phone: 774-826-3721
e-mail: jennifer.moye@va.gov


Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01324102     History of Changes
Other Study ID Numbers: D7629-P
Study First Received: March 4, 2011
Results First Received: December 2, 2014
Last Updated: May 20, 2015
Health Authority: United States: Federal Government