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Project Title BEAT Cancer Study

Researcher Edward McAuley, PhD, University of Illinois at Urbana-Champaign, Urbana, IL and Laura Rogers, MD, MPH, at the University of Alabama at Birmingham

Study Summary This study is evaluating the effectiveness of the BEAT Cancer program for breast cancer survivors. The research team will compare the effects of the intervention to usual care (written materials about exercise for cancer survivors) on short- and longer-term physical activity adherence among breast cancer survivors.

Who Can Participate? You can join the BEAT Cancer Study if you match ALL of these MAIN categories:

• You are a woman between 19 and 70 years old

• You have been diagnosed with Stage 0 (DCIS), I, II, or IIIa breast cancer at some point in your life

• You are NOT currently receiving (and do not plan to receive during the study) chemotherapy or radiation therapy (it is OK if you are taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.)

• You have NOT been exercising, on average, more than 60 minutes per week at a moderate intensity or 30 minutes per week at a vigorous intensity for the past six months

• You are physically able to walk

• You do NOT have a diagnosis of dementia or organic brain syndrome

• You agree to allow study staff to request and obtain medical clearance for study participation from your primary care physician or oncologist

• You speak English

• You live near or are willing to travel (at your own expense) to University of Illinois at Urbana-Champaign in Urbana, IL OR University of Alabama at Birmingham

After you RSVP, the researcher will ask you additional questions to be sure that this study is a right fit for you.

What Does Participation Involve? If you agree to participate in the BEAT Cancer Study you will be contacted by phone to answer questions about your breast cancer diagnosis and treatment, medical history, and physical activity history. If you are eligible, and if you decide to join the study, you will then be randomly assigned (like the flip of a coin) to one of two groups.

If you are assigned to Group A, the intervention study group, you:

• Will be asked to go to the study site to participate in 12 individual exercise sessions with an exercise specialist. The sessions will include stretching exercises and an aerobic component, such as treadmill walking.

• Will be asked to go to the study site to attend six discussion group sessions with a professional counselor. These meetings will occur in the early evenings on a weekday.

• Will be asked to go to the study site to attend three face-to-face counseling update sessions with an exercise specialist after you have completed the 12 exercise sessions.

• Will be asked to perform unsupervised exercise at home.

• Will receive written materials about exercise for cancer survivors.

• Will complete assessments at four time points: before you begin the BEAT Cancer program; after month 3; after month 6; and after month 12. The assessment panels include: a treadmill test; muscle strength test; measurement of your height, weight, waist, and hips; completion of questionnaires; a three-day diet record; wearing a motion sensor for seven days and nights [this small device (similar to a pedometer) measures your activity and is worn around your waist]; and recording the times you go to and get up from bed during the seven days you wear the motion sensor.

If you are assigned to Group B, the usual care group, you:

• Will receive written materials about exercise for cancer survivors.

• Will complete assessments at four time points: before you begin the program; after month 3; after month 6; and after month 12. The assessment panels include: a treadmill test; muscle strength test; measurement of your height, weight, waist, and hips; completion of questionnaires; a three-day diet record; wearing a motion sensor for seven days and nights [this small device (similar to a pedometer) measures your activity and is worn around your waist]; and recording the times you go to and get up from bed during the seven days you wear the motion sensor.

• Will receive the option of receiving tailored exercise recommendations and three individual sessions with an exercise specialist up to 3 months after the completion of the program.

The researchers need to enroll up to 256 women in this study.

Where? University of Illinois at Urbana-Champaign, Urbana, IL and University of Alabama at Birmingham