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

July 22, 2008
February 20, 2013
April 2006
February 2008   (final data collection date for primary outcome measure)
change in physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change in physical activity [ Time Frame: 3 mos and 6 mos ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00721565 on ClinicalTrials.gov Archive Site
  • 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 ]
social cognitive and biopsychosocial outcomes [ Time Frame: 3 mos and 6 mos ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial; Pilot Study)
An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial)

"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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Behavioral: Exercise Behavior Change
attend 12 supervised exercise sessions, attend 6 group sessions with psychologist, attend 3 counseling sessions with exercise specialist
  • Experimental: 1
    behavior change intervention
    Intervention: Behavioral: Exercise Behavior Change
  • No Intervention: 2
    written materials

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
August 2008
February 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721565
ROG-SCCI 08-001-1, SCRIHS 05-071, E200634
Yes
Laura Rogers, MD, MPH, University of Alabama at Birmingham
Southern Illinois University
Not Provided
Principal Investigator: Laura Q. Rogers, MD, MPH Southern Illinois University School of Medicine
Southern Illinois University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP