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Yoga Study in Breast Cancer Patients (Yoga)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Delayed yoga classes
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Yoga, Quality of Life, Obesity, Fatigue, Weight

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • Age 21-75
  • Diagnosed with a primary breast cancer Stage 0-IIIa
  • Current tamoxifen or aromatase inhibitor use is allowed
  • At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)
  • BMI: 24 kg/m2 or greater (If Asian or Asian-American BMI: 23 kg/m2 or greater)
  • No contraindications to participating in a yoga program
  • Able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in English
  • Gives informed consent, agrees to be randomly assigned

Exclusion Criteria:

  • Plans to leave the study area within the follow-up period
  • Is pregnant or plans to become pregnant during the study period.
  • History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)
  • Has practiced yoga more than 1 time per month in the past six months.
  • Current use of medications likely to interfere with adherence to interventions or study outcomes
  • Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Immediate yoga classes offered

Delayed yoga classes (after 6 months) offered [wait list control group]

Outcomes

Primary Outcome Measures

quality of life, fatigue, and body weight

Secondary Outcome Measures

waist and hip circumference

Full Information

First Posted
May 17, 2007
Last Updated
November 27, 2012
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00476203
Brief Title
Yoga Study in Breast Cancer Patients
Acronym
Yoga
Official Title
Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.
Detailed Description
Women who are overweight or obese have a higher risk of breast cancer than normal weight women. Furthermore, women who are overweight or obese or gain weight after diagnosis have an increased risk of recurrence or dying from breast cancer compared with normal weight women. Yoga has been associated with reduced weight gain and weight loss in persons without cancer. However, no studies have tested whether yoga leads to less weight gain or weight loss in breast cancer patients. Both obesity and the sequelae of breast cancer therapy can result in reduced health-related quality of life and severe fatigue, which may also be favorably affected by yoga practice. The specific aims of the proposed trial are to examine, in women with Stage 0-IIIa breast cancer who are at least 3 months post primary treatment for their disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga intervention on health-related quality of life, fatigue, and body weight.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Yoga, Quality of Life, Obesity, Fatigue, Weight

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Immediate yoga classes offered
Arm Title
2
Arm Type
Other
Arm Description
Delayed yoga classes (after 6 months) offered [wait list control group]
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Instructor-led yoga classes 1/time per week + 4 days of home practice
Intervention Type
Other
Intervention Name(s)
Delayed yoga classes
Intervention Description
Delayed yoga classes (after 6 months) offered [wait list control group]
Primary Outcome Measure Information:
Title
quality of life, fatigue, and body weight
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
waist and hip circumference
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Age 21-75 Diagnosed with a primary breast cancer Stage 0-IIIa Current tamoxifen or aromatase inhibitor use is allowed At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy) BMI: 24 kg/m2 or greater (If Asian or Asian-American BMI: 23 kg/m2 or greater) No contraindications to participating in a yoga program Able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in English Gives informed consent, agrees to be randomly assigned Exclusion Criteria: Plans to leave the study area within the follow-up period Is pregnant or plans to become pregnant during the study period. History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis) Has practiced yoga more than 1 time per month in the past six months. Current use of medications likely to interfere with adherence to interventions or study outcomes Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyson Littman, PhD
Organizational Affiliation
Department of Epidemiology, UW
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anne McTiernan, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21207071
Citation
Littman AJ, Bertram LC, Ceballos R, Ulrich CM, Ramaprasad J, McGregor B, McTiernan A. Randomized controlled pilot trial of yoga in overweight and obese breast cancer survivors: effects on quality of life and anthropometric measures. Support Care Cancer. 2012 Feb;20(2):267-77. doi: 10.1007/s00520-010-1066-8. Epub 2011 Jan 5.
Results Reference
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Yoga Study in Breast Cancer Patients

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