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The Physical and Psychological Benefits of Yoga and Breast Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01230671
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Sarkis Meterissian, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE October 27, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date October 25, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
Range of motion of the shoulders [ Time Frame: 12 weeks ]
The range of motion of the shoulders will be measured before and after the 12 week session and then compared.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
Anxiety [ Time Frame: 12 weeks ]
The participants will fill in questionnaires (HADS and the Distress Thermometer) before and after the 12 week session and the results will be compared.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Physical and Psychological Benefits of Yoga and Breast Cancer
Official Title  ICMJE The Physical and Psychological Benefits of Yoga in Patients With Breast Cancer: A Feasibility Study
Brief Summary Breast Cancer is the most common cancer amongst Canadian women. Studies report that breast cancer patients are the most likely to use complementary medicine within the oncologic population. Yoga has become especially popular with this group as it promises to improve the mind, body and soul holistically. The investigators yoga program specifically focuses on rebuilding physical strength, increasing flexibility and reducing the pain and stress associated with the post-operative period. This study will examine how yoga can help improve the overall quality of life and its effects on the physical well-being of women with breast cancer. With positive statistical results, the investigators hope to implement yoga as part of their rehabilitation services at the Cedars Breast Clinic.
Detailed Description

Proposed Intervention:

1-hour hatha yoga classes, once a week for a 12-week period. One class will be offered in French, another in English. The class will begin with approximately 10 minutes of pranayama (breathing exercises) and meditation, followed by 30 minutes of yoga poses and ending with 10 minutes of sivasana (rest period.) The first couple of classes in the 12 week series will begin with restorative postures and will gradually progress to more gentle exercises. If health permits, the last couple of classes will involve some strengthening poses. A small portion of the class will work with the physical body in general and there will be a specific emphasis on the physical difficulties faced by most breast cancer patients, i.e. neck, chest, shoulders arms and hands.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE Other: Yoga
A 12 week yoga session will be offered to women with breast cancer.
Study Arms  ICMJE
  • Experimental: Yoga
    Patients in this arm will receive yoga therapy
    Intervention: Other: Yoga
  • Placebo Comparator: No yoga
    Patients will not have yoga in this arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ages between 18-70
  • Stage I to II breast cancer
  • Minimum of 6 weeks Post Operative status

Exclusion Criteria:

  • Previous/Current psychiatric history
  • Concurrently involved in a yoga program
  • Inability to undergo yoga training secondary to physical/health limitations outlined by the treating team
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230671
Other Study ID Numbers  ICMJE 10-059-PSY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sarkis Meterissian, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE Dr. Sarkis Meterissian
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP