Status:
COMPLETED
Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Conditions:
Atypical Ductal Breast Hyperplasia
Atypical Lobular Breast Hyperplasia
Eligibility:
FEMALE
35-65 years
Phase:
NA
Brief Summary
This randomized clinical trial studies a group-based lifestyle intervention or usual care in measuring biomarker levels in participants at high risk for breast cancer. Studying the effects that change...
Detailed Description
PRIMARY OBJECTIVES: I. To calculate eligibility rates, participation rates, retention, and adherence within the Diet, Exercise and Estrogen Metabolites (DEEM) study. II. To determine inter- and intr...
Eligibility Criteria
Inclusion
- Women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:
- A Gail model risk of \>= 1.7% over 5
- Claus model lifetime risk of \> 20%
- Tyrer-Cuzick model lifetime risk \> 20%
- Personal history of breast biopsy showing atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS)
- Ductal carcinoma in situ (DCIS) that has been previously treated; patients must be at least 2 months from completion of primary therapy not currently on hormonal therapy
- Deleterious mutation in breast cancer (BRCA)1 or BRCA2 another gene known to increase the risk of developing breast cancer
- Risk assessment of 20% chance or greater of carrying a BRCA1/2 gene mutation; the BRCAPRO model will be used to assess this risk
- Body mass index (BMI)
- For postmenopausal women: a BMI of \> 28 and \< 40
- For premenopausal women: a BMI of \> 25 and \< 40
- Willingness to provide informed consent
- Physically able to undertake a moderate exercise program (assessed at the clinic visit)
- Participant has the ability to attend weekly group counseling sessions and subsequent clinic visits
- Participant has the ability to communicate in English
- Participant agrees to be randomly assigned
Exclusion
- Women who are currently engaged in more than 90 min of moderate to vigorous exercise per week at the time of recruitment
- Alcohol/drug abuse or significant mental illness, as assessed by study personnel
- Previous diagnosis of invasive cancer within the past 5 years (in situ breast cancer and simple basal or squamous cell carcinoma not included)
- Plans to leave the geographic area within six months
- Contraindications for treadmill testing or entry into a training program
- Pregnant women or women planning to be pregnant in the following year will not be admitted in to the study
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01874184
Start Date
October 1 2013
Last Update
January 20 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109