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The Physical and Psychological Benefits of Yoga and Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Yoga
Sponsored by
Dr. Sarkis Meterissian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cedar's Breast Clinic, Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yoga

No yoga

Arm Description

Patients in this arm will receive yoga therapy

Patients will not have yoga in this arm

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 27, 2010
Last Updated
October 24, 2013
Sponsor
Dr. Sarkis Meterissian
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1. Study Identification

Unique Protocol Identification Number
NCT01230671
Brief Title
The Physical and Psychological Benefits of Yoga and Breast Cancer
Official Title
The Physical and Psychological Benefits of Yoga in Patients With Breast Cancer: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Sarkis Meterissian

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
Patients in this arm will receive yoga therapy
Arm Title
No yoga
Arm Type
Placebo Comparator
Arm Description
Patients will not have yoga in this arm
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
A 12 week yoga session will be offered to women with breast cancer.
Primary Outcome Measure Information:
Title
Range of motion of the shoulders
Description
The range of motion of the shoulders will be measured before and after the 12 week session and then compared.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Anxiety
Description
The participants will fill in questionnaires (HADS and the Distress Thermometer) before and after the 12 week session and the results will be compared.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cedar's Breast Clinic, Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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The Physical and Psychological Benefits of Yoga and Breast Cancer

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