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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Depression, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Weight Changes

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

- Diagnosis of primary breast cancer

- Newly diagnosed stage I or II disease

- Receiving care at a participating Fox Chase Cancer Center CCOP Research Base (FCRB)
member site

- Geisinger Clinic and Medical Center (phase I)

- Main Line Health (phase I)

- Any of the other participating FCRB member sites (phase II)

- Study intervention is scheduled to begin anytime after surgery up to 3 months after
completion of adjuvant chemotherapy

- Treatment plan includes adjuvant chemotherapy

- Hormone receptor status not specified

Exclusion criteria:

- Treatment plan includes trastuzumab (Herceptin®) or bevacizumab

- Recurrent breast cancer

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Female

- Premenopausal or postmenopausal

- Has obtained medical clearance by oncologist and breast surgeon to participate in
this study

- Body mass index ≥ 20 kg/m^2 and < 39 kg/m^2

Exclusion criteria:

- Hemoglobin < 12 g/dL

- ANC < 1,500/mm^3

- Any medical condition that restricts participation in a physical activity program
(e.g., exercise-induced angina, uncontrolled hypertension, dementia, or a major
psychological problem)

- Answers "yes" to any questions on the Physical Activity Readiness Questionnaire
(PAR-Q) and PAR-Q not reviewed by a physician who subsequently approves participation
in the physical activity intervention

- Known to be pregnant or breastfeeding

- Unwilling to commit or unable to participate in a 6-month physical activity
intervention (unable to exercise, usually travels away from home overnight more than
once per week, and/or has plans to be away from home for more than two weeks in the
next 6 months)

- Previously diagnosed with another primary cancer other than basal cell or squamous
cell carcinoma of the skin

- Exercising regularly prior to intervention (i.e., reports current participation in
vigorous or moderate activity at least 3 days per week for at least 30 minutes each
day on the International Physical Activity Questionnaire)

- Unable to speak and read English

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No neoadjuvant chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Accrual (phase I)

Safety Issue:

No

Principal Investigator

Penny Anderson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000555830

NCT ID:

NCT00509626

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Depression
  • Fatigue
  • Psychosocial Effects of Cancer and Its Treatment
  • Weight Changes
  • fatigue
  • psychosocial effects of cancer and its treatment
  • weight changes
  • depression
  • stage I breast cancer
  • stage II breast cancer
  • Body Weight Changes
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue
  • Weight Gain

Name

Location

Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497