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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01230671
Other study ID # 10-059-PSY
Secondary ID
Status Completed
Phase Phase 1
First received October 27, 2010
Last updated October 24, 2013
Start date August 2010
Est. completion date October 2013

Study information

Verified date October 2013
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Yoga
A 12 week yoga session will be offered to women with breast cancer.

Locations

Country Name City State
Canada Cedar's Breast Clinic, Royal Victoria Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Dr. Sarkis Meterissian

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion of the shoulders The range of motion of the shoulders will be measured before and after the 12 week session and then compared. 12 weeks No
Secondary Anxiety The participants will fill in questionnaires (HADS and the Distress Thermometer) before and after the 12 week session and the results will be compared. 12 weeks No
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