Diet, Exercise and Estrogen Metabolites Study (DEEM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Movement through the stages of change (pre-contemplation, contemplation, action, and maintenance) and data collected from quality of life questionnaires
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Movement through the stages of change (pre-contemplation, contemplation, action, and maintenance) and data collected from quality of life questionnaires
时间窗: 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.
Level of adherence to the exercise component evaluated using the physical activity logs
时间窗: 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
时间窗: 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
时间窗: 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 percentage of total fat
时间窗: Baseline to up to 6 months
Linear regression models will be used for correlated outcomes.
Level of adherence to the dietary component evaluated using the 3-day food records
时间窗: 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.
Change in EDA biomarker levels
时间窗: 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
时间窗: Baseline to up to 6 months
Linear regression models will be used for correlated outcomes.
Change in BMI
时间窗: Baseline to up to 6 months
Linear regression models will be used for correlated outcomes.
次要结局
- Differences in change of the DNA repair assay in intervention participants versus controls(Baseline to up to 3 months)