Trial Information

A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients

OBJECTIVES:

Primary

- Determine the feasibility for conducting a clinical trial that uses a 6-month physical
activity intervention initiated within 45 days after surgery for early-stage breast
cancer and prior to initiation of adjuvant chemotherapy, hormonal therapy, and/or
radiotherapy. (phase I)

- Determine if participation in a 6-month physical activity intervention initiated within
45 days after surgery for early-stage breast cancer decreases weight gain in patients
treated with adjuvant chemotherapy. (phase II)

- Determine if participation in a 6-month physical activity intervention initiated within
45 days after surgery for early-stage breast cancer differentially affects weight
change in women who are premenopausal compared to those who are postmenopausal at
diagnosis. (phase II)

Secondary

- Determine if participation in a 6-month physical activity intervention initiated within
45 days after surgery for early-stage breast cancer decreases gains in adiposity in
patients treated with adjuvant chemotherapy. (phase II)

- Determine if participation in a 6-month physical activity intervention initiated within
45 days after surgery for early-stage breast cancer differentially affects change in
adiposity among women who are premenopausal compared to those who are postmenopausal at
diagnosis. (phase II)

- Determine if participation in a 6-month physical activity intervention initiated within
45 days after surgery for early-stage breast cancer decreases the frequency of
depressive symptomology and improves quality of life among patients treated with
adjuvant chemotherapy. (phase II)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating site and menopausal status (premenopausal vs postmenopausal). Patients are
randomized to 1 of 2 intervention arms.

- Arm I (exercise and usual care): Patients receive usual care and are enrolled in an
exercise and weight control program at Curves® fitness center. The Curves® program,
which begins during the third week of study, uses aerobic activity and resistance
training to reduce weight and increase strength and fitness. Patients exercise a
minimum of 3 times per week, approximately 30 minutes every time, for up to 6 months in
the absence of disease progression or unacceptable toxicity. Patients' physical
activity is measured at baseline and at the 3- and 6-month follow-up visits.

Patients also undergo behavior modification counseling with a study nurse to help them
overcome the specific barriers to adhering to the recommended exercise routine. Counseling
sessions are conducted every 2 to 3 weeks during chemotherapy and at least monthly after
completion of chemotherapy for up to 6 months, starting within 2 weeks after randomization
and prior to initiation of the Curves® intervention.

- Arm II (control: usual care alone): Patients receive usual care and general advice on
coping with their breast cancer treatment for up to 6 months in the absence of disease
progression or unacceptable toxicity. Patients receive no counseling or recommendations
concerning emotional and practical barriers encountered during breast cancer treatment.

Dietary information is obtained from patients by telephone during three 24-hour dietary
recalls performed within 2 weeks of baseline and at the 3-month and 6-month follow-up visits
to estimate total energy intake throughout the study. Patients complete questionnaires at
baseline and periodically during study assessing demographic characteristics and established
breast cancer risk factors, medical history, and health changes. Weight, adiposity as
measured by waist circumference, quality of life, and depressive symptomology are assessed
at baseline and at the 3- and 6-month follow-up visits.

After completion of the study intervention, patients are followed for up to 6 months.