An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial) - Full Text View

Sponsored by:	Southern Illinois University
Information provided by:	Southern Illinois University
ClinicalTrials.gov Identifier:	NCT00721565

Purpose

"Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients.

Condition	Intervention	Phase
Breast Cancer	Behavioral: Exercise Behavior Change	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial)

Further study details as provided by Southern Illinois University:

Primary Outcome Measures:

change in physical activity [ Time Frame: 3 mos and 6 mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

social cognitive and biopsychosocial outcomes [ Time Frame: 3 mos and 6 mos ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental behavior change intervention	Behavioral: Exercise Behavior Change attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist
2: No Intervention written materials

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are currently taking aromatase inhibitors or selective estrogen receptor modulators for the next 8 months.
English speaking
Medical clearance for participation provided by primary care physicians
If the patient has undergone a surgical procedure, must be at least 6 weeks post-procedure

Exclusion Criteria:

Diagnosis of dementia or organic brain syndrome
Medical, psychological or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.)
Contraindication to participation in a regular physical activity program.
Metastatic or recurrent disease
Inability to ambulate
Engaged in >/= 60 minutes of vigorous physical activity or >/= 150 minutes of moderate plus vigorous physical activity per week during the past month.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721565

Locations

United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702

Sponsors and Collaborators

Southern Illinois University

Investigators

Principal Investigator:

Laura Q. Rogers, MD, MPH

Southern Illinois University School of Medicine

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Southern Illinois University School of Medicine ( Laura Q. Rogers, MD, MPH, FACP, FACSM/ Assistant Professor )
Study ID Numbers:	SCCI 08-001-1, SCRIHS 05-071
Study First Received:	July 22, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00721565
Health Authority:	United States: Institutional Review Board

Keywords provided by Southern Illinois University:

Breast Cancer, Exercise, Social Cognitive Theory, Adherence, Symptoms, Body Composition

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009