NCT01874184

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

June 6, 2013

Last Update Submit

January 15, 2016

Conditions

Atypical Ductal Breast HyperplasiaAtypical Lobular Breast HyperplasiaBRCA1 Mutation CarrierBRCA2 Mutation CarrierDuctal Breast Carcinoma in SituLobular Breast Carcinoma in Situ

Outcome Measures

Primary Outcomes (9)

  • 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.

    Up to 9 months

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

    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.

    Up to 9 months

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

    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.

    Up to 9 months

  • 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.

    Up to 3 months

  • Change in EDA biomarker levels

    Linear regression models will be used for correlated outcomes.

    Baseline to up to 6 months

  • Change in BMI

    Linear regression models will be used for correlated outcomes.

    Baseline to up to 6 months

  • Change in percentage of total fat

    Linear regression models will be used for correlated outcomes.

    Baseline to up to 6 months

  • Change in percentage of body fat as measured by BMI

    Linear regression models will be used for correlated outcomes.

    Baseline to up to 6 months

  • 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.

    Up to 9 months

Secondary Outcomes (1)

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

    Baseline to up to 3 months

Study Arms (2)

Arm I (DEEM intervention)

EXPERIMENTAL

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.

Other: counseling interventionBehavioral: behavioral dietary interventionBehavioral: exercise interventionOther: questionnaire administrationOther: laboratory biomarker analysis

Arm II (usual care)

NO INTERVENTION

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

Interventions

counseling interventionOTHER

Take part in weekly group counseling sessions

Also known as: counseling and communications studies
Arm I (DEEM intervention)
behavioral dietary interventionBEHAVIORAL

Set goals for changing dietary habits

Arm I (DEEM intervention)
exercise interventionBEHAVIORAL

Attend group exercise activities

Arm I (DEEM intervention)
questionnaire administrationOTHER

Ancillary studies

Arm I (DEEM intervention)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (DEEM intervention)

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +1 more criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

    PMID: 30616442DERIVED

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

Counseling

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kerryn Reding

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 10, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

US(1)