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

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 intra-person variability of the estrogen-deoxyribonucleic acid
(DNA) adducts (EDA) biomarkers in participants of the DFS.

III. To explore the effects of the intervention on percent adiposity and the EDA ratio at
the end of the 3-month intervention and 6-month follow-up.

SECONDARY OBJECTIVES:

I. To explore the effects of the intervention on the DNA damage repair (DDR) biomarker at
3-months.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants take part in weekly 2-hour group counseling sessions for 6 months with
taper beginning at 3 months. Group sessions include education, group process, and
experiential learning on the benefits of physical activity, balanced nutrition, and
mindfulness techniques. Participants set goals for changing their dietary habits with the
help of a mental health counselor and are also encouraged to exercise 3-4 times per week,
including experiential group activities such as brisk walking, yoga, Zumba, and group
fitness.

ARM II: Participants receive their usual care and are also provided with study materials on
healthy diet and exercise at the end of the study.

After completion of study, participants are followed up for 3 months.

Inclusion Criteria:

- 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 Criteria:

- 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