Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer

Completed · Not applicable

Conditions studied: Atypical Ductal Breast Hyperplasia, Atypical Lobular Breast Hyperplasia, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ

In brief

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 changes to daily eating and exercise habits can have on the body's hormone levels and the body's ability to activate proteins may help doctors identify interventions for individuals at high risk for breast cancer.

Key facts

Study ID

NCT01874184

Run by

University of Washington

People needed

17

Starts

2013-10-01

Last updated by the study team

2016-01-20

Who can join

Age: 35 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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