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 diagnosis.
Behavioral: Experimental 1: exercise with 2 counseling types
Other: Usual Care - written materials
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Locations near you
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Full eligibility criteria for NCT00929617
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
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).
All locations for NCT00929617
United States (3)
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of Illinois
Champaign, Illinois, United States, 61801
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
View full eligibility
Tris trial is registered with FDA with number: NCT00929617. The sponsor of the trial is University of Alabama at Birmingham and it is looking for 356 volunteers for the current phase.
Official trial title: Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
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