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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura Rogers, MD, MPH, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00721565
First received: July 22, 2008
Last updated: February 20, 2013
Last verified: February 2013
  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 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 Intervention Phase
Breast Cancer
Behavioral: Exercise Behavior Change
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial)

Resource links provided by NLM:


Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • change in physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • social cognitive and biopsychosocial outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • social cognitive and biopsychosocial outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: April 2006
Study Completion Date: August 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Laura 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, E200634
Study First Received: July 22, 2008
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Illinois University:
Breast Cancer
Exercise
Social Cognitive Theory
Adherence
Symptoms
Body Composition

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

ClinicalTrials.gov processed this record on July 26, 2014