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A Pilot Study of a Three Month Intervention for Increasing Physical Activity in Sedentary Women at Risk for Breast Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Breast Neoplasms

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Trial Information

A Pilot Study of a Three Month Intervention for Increasing Physical Activity in Sedentary Women at Risk for Breast Cancer


Evidence suggests that high levels of physical activity can decrease breast cancer risk.

Physical activity could therefore represent a viable breast cancer prevention strategy.

In order to study the effect of physical activity on breast cancer risk, we must first
develop feasible and efficacious physical activity interventions.



To determine the rate of compliance with a physical activity intervention using a pedometer,
a physician prescription, and a motivational booklet.

To determine whether this intervention is more effective than a control of stretching
exercises at increasing physical activity.


To determine whether physical activity as measured by a pedometer correlates with other
measures of physical activity.

To assess the effect of the physical activity intervention on serum biomarkers, quality of
life, functional capacity and body composition.

To examine long-term compliance with a program of increased physical activity and assess
post program exercise motivation and adherence.


Eligible patients are women age 18-75 who meet one of the following criteria:

History of breast cancer without evidence of recurrent disease.

Gail model 5 year risk greater than 1.7%.

Claus model lifetime risk greater than 20%.

History of appropriately treated DCIS.

History of high risk lesion on breast biopsy (ADH, ALH, LCIS).

Known or suspected BRCA1 or BRCA2 mutation.

Patients must be sedentary at baseline and must be medically fit to exercise.


This is a randomized pilot study designed to assess the feasibility of a physical activity
intervention in breast cancer survivors and women at high risk for breast cancer.

Stage I: Patients undergo a baseline activity evaluation for one week which involves wearing
a sealed pedometer - those that have an average daily step count of less than 5,000 steps
are eligible for randomization.

Stage II: Patients are assigned to either a walking intervention, (including a pedometer, a
physician exercise prescription with a final goal of walking 10,000 steps per day, and a
motivational booklet) or a control of stretching exercise for a period of 12 weeks.

Biomarkers, functional capacity, body composition and diet are assessed at the beginning and
end of study.

This study plans to randomize 80 subjects, and has a greater than 90% power to detect a mean
increase of 3,000 steps per day in intervention subjects.

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.

Cardiac risk will be assessed after a complete history and physical exam, and will be
determined by the examining physician. Only patients who are felt to be increased cardiac
risk will have an EKG performed. This will include patients who answer yes to any of the
questions on the PAR-Q that assess cardiac risk (#1,2,3,4,6). Patients with worrisome EKG
findings or findings in the history or physical exam that warrant further work-up in the
opinion of the health care provider will be referred to the cardiology consult service, or
if non-urgent, will be referred back to their source of regular medical care for clearance
prior to enrolling on the study.

If history of cancer (other than invasive breast cancer, squamous or basal cell skin
cancers), subject 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 two 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 or equal to1.7 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. Patients must be at
least 2 months from completion of primary therapy, and if treated with hormonal therapy,
they must have completed at least two months of hormonal therapy.

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 (109) will be used to
assess this risk.


Currently pregnant or planning to become pregnant during the study period. Pregnancy will
be assessed in women of childbearing potential prior to enrolling in stage II of the
study. Postmenopausal women and women who have had a previous hysterectomy, oophorectomy
or tubal ligation will not be required to undergo a 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.

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

September 2004

Completion Date:

December 2009

Related Keywords:

  • Breast Neoplasms
  • Exercise
  • Pedometer
  • Physician Prescription
  • Biomarkers
  • Compliance
  • Breast Cancer Survivor
  • Breast Cancer Risk
  • Breast Neoplasms
  • Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892