Status:
COMPLETED
Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II)
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer dia...
Detailed Description
Physical activity may improve quality of life, the control of comorbid conditions, and weight management while reducing breast cancer recurrence and mortality among breast cancer survivors. Unfortunat...
Eligibility Criteria
Inclusion
- Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or IIIA breast cancer and who are not currently receiving (and do not plan to receive during the duration of the study) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. The upper age limit of 70 years was chosen to reduce the likelihood of adverse events or study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that occur with age.
- If the patient has undergone a surgical procedure, enrollment will be delayed until ≥ 8 weeks post-procedure.
- English speaking.
- Medical clearance for participation provided by primary care physician or oncologist.
- Participating, on average, in no more than 60 minutes of moderate physical activity or no more than 30 minutes of vigorous activity per week during the past six months.
Exclusion
- 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.
- Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
- Planned travel that would interfere with scheduled study sessions (no travel in the 1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT00929617
Start Date
June 1 2009
End Date
March 1 2017
Last Update
October 21 2021
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Illinois
Champaign, Illinois, United States, 61801
3
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702