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

Primary Purpose

Atypical Ductal Breast Hyperplasia, Atypical Lobular Breast Hyperplasia, BRCA1 Mutation Carrier

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

counseling intervention

behavioral dietary intervention

exercise intervention

questionnaire administration

laboratory biomarker analysis

About this trial

This is an interventional basic science trial for Atypical Ductal Breast Hyperplasia

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I (DEEM intervention)

Arm II (usual care)

Arm 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.

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

Outcomes

Primary Outcome Measures

Level of adherence to the dietary component evaluated using the 3-day food records

Descriptive statistics will be calculated. The percentage of women meeting the study's eligibility criteria, percentage of those who agree to participate, and the percentage of those who complete the study will be stratified by intervention group. This analysis will summarize data collected from the participants' into themes.

Level of adherence to the exercise component evaluated using the physical activity logs

Level of adherence to the group counseling sessions component evaluated by tracking attendance

Inter-person variability

The variance of the EDA biomarkers will be calculated in all participants at baseline, and stratify upon study arm. In order to determine the level of variance for biomarkers that is due to between-person variation in relation to the amount of variance that is due to within-person variance, the intra-class correlation coefficient will be calculated among the controls, which is based on the analysis of variance.

Change in EDA biomarker levels

Linear regression models will be used for correlated outcomes.

Change in BMI

Linear regression models will be used for correlated outcomes.

Change in percentage of total fat

Linear regression models will be used for correlated outcomes.

Change in percentage of body fat as measured by BMI

Linear regression models will be used for correlated outcomes.

Movement through the stages of change (pre-contemplation, contemplation, action, and maintenance) and data collected from quality of life questionnaires

The participant's baseline level of readiness for change modified the effect of the intervention will be investigated, with the hypothesis that the largest impact will be observed within those with the highest level of readiness for change.

Secondary Outcome Measures

Differences in change of the DNA repair assay in intervention participants versus controls

Analysis of variance will be used.

Full Information

NCT ID

NCT01874184

First Posted

June 6, 2013

Last Updated

January 15, 2016

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT01874184

Brief Title

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

Acronym

DEEM

Official Title

Diet, Exercise and Estrogen Metabolites Study (DEEM)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (DEEM intervention)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (usual care)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

counseling intervention

Other Intervention Name(s)

counseling and communications studies

Intervention Description

Take part in weekly group counseling sessions

Intervention Type

Behavioral

Intervention Name(s)

behavioral dietary intervention

Intervention Description

Set goals for changing dietary habits

Intervention Type

Behavioral

Intervention Name(s)

exercise intervention

Intervention Description

Attend group exercise activities

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Level of adherence to the dietary component evaluated using the 3-day food records

Description

Time Frame

Up to 9 months

Title

Level of adherence to the exercise component evaluated using the physical activity logs

Description

Time Frame

Up to 9 months

Title

Level of adherence to the group counseling sessions component evaluated by tracking attendance

Description

Time Frame

Up to 9 months

Title

Inter-person variability

Description

Time Frame

Up to 3 months

Title

Change in EDA biomarker levels

Description

Linear regression models will be used for correlated outcomes.

Time Frame

Baseline to up to 6 months

Title

Change in BMI

Description

Linear regression models will be used for correlated outcomes.

Time Frame

Baseline to up to 6 months

Title

Change in percentage of total fat

Description

Linear regression models will be used for correlated outcomes.

Time Frame

Baseline to up to 6 months

Title

Change in percentage of body fat as measured by BMI

Description

Linear regression models will be used for correlated outcomes.

Time Frame

Baseline to up to 6 months

Title

Movement through the stages of change (pre-contemplation, contemplation, action, and maintenance) and data collected from quality of life questionnaires

Description

Time Frame

Up to 9 months

Secondary Outcome Measure Information:

Title

Differences in change of the DNA repair assay in intervention participants versus controls

Description

Analysis of variance will be used.

Time Frame

Baseline to up to 3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerryn Reding

Organizational Affiliation

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30616442

Citation

Stone SA, Han CJ, Senn T, Korde LA, Allott K, Reding S, Whittington D, Reding KW. Sex Hormones in Women With Elevated Breast Cancer Risk Undergoing Weight Loss. West J Nurs Res. 2019 Nov;41(11):1602-1622. doi: 10.1177/0193945918820672. Epub 2019 Jan 7.

Results Reference

derived

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

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