Atypical Ductal Breast HyperplasiaDEEMNCT01874184
Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer
A study testing counseling intervention, behavioral dietary intervention and exercise intervention in people with Atypical Ductal Breast Hyperplasia and Atypical Lobular Breast Hyperplasia, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Atypical Ductal Breast Hyperplasia, Atypical Lobular Breast Hyperplasia, BRCA1 Mutation Carrier
- What is being tested?
- counseling intervention, behavioral dietary intervention and exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Diet, Exercise and Estrogen Metabolites Study (DEEM)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Atypical Ductal Breast Hyperplasia, Atypical Lobular Breast Hyperplasia, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
- Being tested
- counseling intervention, behavioral dietary intervention, exercise intervention, questionnaire administration, laboratory biomarker analysis
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
Also called counseling and communications studies
Take part in weekly group counseling sessions
behavioral dietary interventionBehavioural
Set goals for changing dietary habits
exercise interventionBehavioural
Attend group exercise activities
questionnaire administrationOther
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: counseling intervention; Behavioral: behavioral dietary intervention; Behavioral: exercise intervention; Other: questionnaire administration; Other: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Change in EDA biomarker levels
Linear regression models will be used for correlated outcomes.
Measured: Baseline to up to 6 months
Change in BMI
Linear regression models will be used for correlated outcomes.
Measured: Baseline to up to 6 months
Change in percentage of total fat
Linear regression models will be used for correlated outcomes.
Measured: 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.
Measured: 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.
Measured: Up to 9 months
Secondary outcomes (1)
Differences in change of the DNA repair assay in intervention participants versus controls
Analysis of variance will be used.
Measured: Baseline to up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atypical Ductal Breast HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Kerryn Reding, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874184
- Sponsor's protocol ID
- 9026
- Other IDs
- NCI-2014-00929, 44358-J, 9026, P30CA015704, R00NR012232
- Acronym
- DEEM
- Status last verified
- Jan 2016
- First submitted
- 6 Jun 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30616442
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Exercise and Estrogen Metabolites Study (DEEM)
- ClinicalTrials.gov ID
- NCT01874184
- Acronym / sponsor ID
- DEEM / 9026
- Conditions
- Atypical Ductal Breast Hyperplasia, Atypical Lobular Breast Hyperplasia, BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (DEEM intervention) | Experimental | Other: counseling intervention, Behavioral: behavioral dietary intervention, Behavioral: exercise intervention, Other: questionnaire administration, Other: laboratory biomarker analysisParticipants 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 (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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:
- Body mass index (BMI)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling interventionAlso: counseling and communications studiesTake part in weekly group counseling sessions | Other | Arm I (DEEM intervention) |
| behavioral dietary interventionSet goals for changing dietary habits | Behavioural | Arm I (DEEM intervention) |
| exercise interventionAttend group exercise activities | Behavioural | Arm I (DEEM intervention) |
| questionnaire administrationAncillary studies | Other | Arm I (DEEM intervention) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (DEEM intervention) |
Primary outcome
Level of adherence to the dietary component evaluated using the 3-day food records
Time frame: Up to 9 months
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
Time frame: Up to 9 months
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 group counseling sessions component evaluated by tracking attendance
Time frame: Up to 9 months
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.
Inter-person variability
Time frame: Up to 3 months
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
Time frame: Baseline to up to 6 months
Linear regression models will be used for correlated outcomes.
Change in BMI
Time frame: Baseline to up to 6 months
Linear regression models will be used for correlated outcomes.
Change in percentage of total fat
Time frame: Baseline to up to 6 months
Linear regression models will be used for correlated outcomes.
Change in percentage of body fat as measured by BMI
Time frame: Baseline to up to 6 months
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
Time frame: Up to 9 months
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.
1 secondary outcome
Differences in change of the DNA repair assay in intervention participants versus controls
Time frame: Baseline to up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Derived from this study: PubMed 30616442Stone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerryn Reding principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, behavioral dietary intervention and exercise intervention in people with Atypical Ductal Breast Hyperplasia and Atypical Lobular Breast Hyperplasia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of adherence to the dietary component evaluated using the 3-day food records (time frame: Up to 9 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.