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An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial; Pilot Study) (BEAT)

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ClinicalTrials.gov Identifier: NCT00721565
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Brief Summary:
"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 hormonal 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 or disease Intervention/treatment Phase
Breast Cancer Behavioral: Exercise Behavior Change Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial)
Study Start Date : April 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
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

No Intervention: 2
written materials



Primary Outcome Measures :
  1. change in physical activity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. social cognitive and biopsychosocial outcomes [ Time Frame: 3 months ]
  2. social cognitive and biopsychosocial outcomes [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721565


Locations
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Laura Q. Rogers, MD, MPH Southern Illinois University School of Medicine

Additional Information:
Publications:
Responsible Party: Laura Q. Rogers, MD, MPH, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00721565     History of Changes
Other Study ID Numbers: ROG-SCCI 08-001-1
SCRIHS 05-071 ( Other Identifier: Institutional Review Board )
E200634 ( Other Grant/Funding Number: Excellence in Academic Medicine SIUSM )
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:
Breast Cancer
Exercise
Social Cognitive Theory
Adherence
Symptoms
Body Composition

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases