Yoga Study in Breast Cancer Patients

NCT00476203 | Completed

• 2 other identifiers: PHS - 6434U54CA116847-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Yoga; Quality of Life; Obesity; Fatigue; Weight

Outcome Measures

Primary Outcomes (1)

• quality of life, fatigue, and body weight

  baseline, 6 months, 12 months

Secondary Outcomes (1)

• waist and hip circumference

  baseline, 6 months, 12 months

Study Arms (2)

1

EXPERIMENTAL

Immediate yoga classes offered

Behavioral: Yoga

2

OTHER

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

Other: Delayed yoga classes

Interventions

Yoga BEHAVIORAL

Instructor-led yoga classes 1/time per week + 4 days of home practice

1

Delayed yoga classes OTHER

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

2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 21207071 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Fatigue; Body Weight

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Alyson Littman, PhD

  Department of Epidemiology, UW

  STUDY DIRECTOR

• Anne McTiernan, MD, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

US (1)