This 2-part study will examine how much exercise people usually do in the course of their daily lives and how two different types of exercise-stretching and walking-affect the amount of fat in the body and certain hormones in the blood. It will also examine whether exercise can be increased by physician counseling with and without the use of a pedometer, and if exercising changes levels of stress, anxiety, and depression.

Breast cancer survivors and women at high risk for breast cancer who are between 18 and 75 years of age and who exercise less than 3 times per week may be eligible for this study. Candidates are screened with a medical history and physical examination, and their endurance and flexibility are tested by stretching exercises and by a 6-minute walk or run.

All participants complete study Part 1. Those who are eligible may also participate in Part 2.

- Part 1: Subjects wear a pedometer (a small device that measures the number of steps taken) on their waistband during all waking hours for 1 week without changing their usual level of activity. Depending on their level of activity, subjects may be invited to participate in Part 2 of the study.

- Part 2: Subjects are placed in either a walking group or a stretching group for 12 weeks. At the end of the 12-week period, those in the walking group are offered participation in the stretching group, and those in the stretching group are offered participation in the walking group.

Walking group participants wear a pedometer every day for 12 weeks. They are asked to gradually increase the number of steps they take each day, to keep a record of their daily step count, and to report periodically to the study staff on their progress. For 1 week during the study, participants also wear a device called an accelerometer that is used to verify the accuracy of the pedometer step counts.

Stretching group participants follow a program of stretching exercises for 12 weeks, with their progress monitored periodically by staff. During week 12, participants wear a pedometer and accelerometer.

All Part 2 participants also have the following tests and procedures:

- Blood draw: collected at the beginning and end of the study to test for certain hormones and HDL cholesterol levels.

- Questionnaires: about stress, anxiety, and depression levels; these are completed at the beginning and end of the study, and a detailed questionnaire about diet is completed at home or during a clinic visit.

- Body composition measurement: A "bioelectrical impedance" test, which measures body fat, is done at the beginning and end of the study. For this test, the subject lies on an examining table and a small electrical current is passed through electrodes placed on one hand and one foot. Although a small electrical current is used, this test is not painful.

- Endurance and flexibility testing: At the end of the study, participants repeat the 6-minute walk or run endurance test and the stretching flexibility test performed at screening.

Condition	Treatment or Intervention	Phase
Breast Neoplasms	Behavior: Physical activity	Phase II

Further Study Details: 

Expected Total Enrollment:  97

Breast cancer is a major public health issue. Energy balance is increasingly thought to be important in determining breast cancer risk, and represents a risk factor that can be impacted by interventions such as lifestyle modifications. Increasing physical activity is a lifestyle change that may impact breast cancer risk, and is likely to be well received by women at high risk for breast cancer because it is without major side effects.

This pilot study will assess the feasibility of a simple lifestyle intervention for increasing physical activity. Eligible women are breast cancer survivors and women at high risk for breast cancer who are sedentary at baseline. Subjects will be randomized to either physical activity intervention or control. Subjects in the physical activity intervention group will receive a pedometer, a physician exercise prescription and a motivational and educational booklet, and will be asked to incrementally increase their amount of daily steps to a goal of 10,000 steps per day. Subjects randomized to the control group will receive instruction on stretching exercises, and will be asked not to alter any other component of physical activity. The primary objectives of the study are to evaluate whether the intervention is successful in increasing levels of physical activity as measured by a validated physical activity questionnaire. The secondary objectives include exploring the effects of our physical activity intervention on biomarkers, quality of life, body composition and functional capacity. This pilot will serve as the first step to designing larger, randomized trials of physical activity interventions with breast cancer risk reduction endpoints, such as mammographic density, serum biomarkers, and ductal lavage fluid in high risk, obese, and underserved populations.

Genders Eligible for Study:  Female

Criteria

INCLUSION CRITERIA:
This study will enroll 40 breast cancer survivors and 40 women at high risk for breast cancer. All participants must fulfill the following criteria:
Age 18 to 75.
Sedentary at baseline, as defined by a weekly leisure-time activity score of 15 or less on the Godin Leisure-Time Exercise Questionnaire. This cutoff is equivalent to engaging in moderate activity less than 3 times a week.
Ability to complete all study questionnaires, or a willing friend or family member who will assist in questionnaire completion.
ECOG performance status 0-1.
Ability to successfully perform the level of physical activity prescribed by the protocol, as assessed by the Physical Activity Readiness Questionnaire (PAR-Q).
Any participant who answers yes to any of the questions in this screening tool will undergo medical evaluation at the Clinical Center, as appropriate, prior to enrolling on the study.
If history of cancer (other than invasive breast cancer, squamous or basal cell skin cancers), subjects must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 2 years preceding enrollment.
Breast cancer survivors:
Eligible breast cancer survivors will be women with a documented history of Stage I, II or III invasive breast cancer who are at least 6 months from the completion of their primary therapy, including surgery, radiation and chemotherapy. Current use of hormonal therapy such as tamoxifen or aromatase inhibitors, will be permitted, however subjects must have completed 2 months of hormonal therapy prior to beginning the study in order to achieve steady state.
Women at high risk for breast cancer:
Women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:
A Gail model risk of greater than 1.7 percent over 5 years from study entry or a Claus model lifetime risk of greater than 20 percent.
Lobular neoplasia.
Atypical ductal hyperplasia.
Ductal carcinoma in situ (DCIS) that has been previously treated with mastectomy or lumpectomy and radiation, plus-minus tamoxifen or an aromatase inhibitor (must have completed 2 months of hormonal therapy prior to beginning study in order to achieve steady state).
Deleterious mutations in BRCA-1 or 2 OR A priori risk assessment of 20 percent chance or greater of carrying a BRCA1/2 gene mutation. The BRCAPRO model will be used to assess this risk.
EXCLUSION CRITERIA:
Currently pregnant or planning to become pregnant during the study period. Pregnancy will be assessed prior to study enrollment using serum or urine pregnancy test.
Uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent myocardial infarction or stroke, or psychiatric illness/social situations that would limit compliance with study requirements.
Physical conditions that preclude the amount of daily walking prescribed by the protocol (e.g., severe arthritis, use of a walker or cane, wheelchair-bound, etc.).
Medical or psychiatric disorder which would, in the opinion of the Principal Investigator, render the subject unable to provide informed consent.
Patients with metastatic or recurrent disease will be excluded because of difficulty interpreting results in the context of women with a disease burden and/or on chemotherapy.

Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  040276; 04-C-0276
Record last reviewed:  August 31, 2004
Last Updated:  November 23, 2004
Record first received:  September 24, 2004
ClinicalTrials.gov Identifier:  NCT00092950
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08