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

University of Washington

Status: Completed

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

Treatments: Other: questionnaire administration; Other: laboratory biomarker analysis; Behavioral: behavioral dietary intervention; Behavioral: exercise intervention; Other: counseling intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01874184

9026 (Other Identifier)

R00NR012232 (U.S. NIH Grant/Contract)

NCI-2014-00929 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

44358-J

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 17 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Arm I (DEEM intervention)

Experimental group

Description:

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.

Treatment:

Behavioral: exercise intervention

Other: counseling intervention

Other: questionnaire administration

Other: laboratory biomarker analysis

Behavioral: behavioral dietary intervention

Arm II (usual care)

No Intervention group

Description:

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