DAMES: Daughters And MothErS Against Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 482
- 试验地点
- 4
- 主要终点
- Overall Accrual
研究概览
简要总结
Primary Aim:
-To explore the feasibility and acceptability of two distinctly different tailored, home-based diet and exercise interventions (one that relies on a partner-assisted, team-based approach that emphasizes the mother-daughter bond and one that is delivered to each independently) vs. standardized materials (attention control). This aim will be accomplished by assessing overall accrual, and by quantifying retention and adverse events in each study arm.
The study will be deemed feasible if it achieves the following criteria:
- Accrual of 67 mother-daughter dyads into the intervention is accomplished within a 1-year period;
- An attrition rate of less than 20% is achieved; and
- The frequency of total adverse events is not significantly higher in either of the intervention arms (as compared to the attention control arm), and there is no more than one reported serious adverse event that is directly attributable to either of the interventions.
Detailed process data also will be collected on each intervention, i.e., use and perceived helpfulness of materials in promoting behavior change, frequency and quality of interaction between members of the mother-daughter dyad, feedback regarding intervention materials, etc.
Secondary Aim:
-To explore potential effects (and variation) noted among each of the three intervention arms from baseline to 6 and 12- month follow-up on the following endpoints: BMI, energy intake and nutrient density of the diet, exercise [min/week and metabolic equivalents (METs)], self-efficacy to adhere to an energy restricted, plant-based, low saturated fat diet and increased exercise, blood pressure, health-related quality of life (HRQOL), social support (in general and as specifically related to healthful dietary and exercise behavior), and characteristics of the mother-daughter bond (e.g., strength).
Secondary Aim:
-To explore potential mediators and moderators of healthful dietary and exercise behaviors, such as the strength of the mother-daughter bond, geographic proximity of mothers and daughters, self-efficacy for lifestyle change, etc.
详细描述
DAUGHTER AND MOTHER - FULL INTERVENTION STUDY:
Women who are overweight have a greater chance of developing breast cancer as they get older, and also are at greater risk of developing more aggressive cancer. Researchers want to study 3 different home-based diet and exercise weight loss programs and find out the effect of the programs on body weight, quality of life, and other health-related factors.
If you and your mother agree to participate in this year-long research study, you will be asked to sign this consent form and send it into our study office in the envelope provided. As soon as the study staff receives these forms from both you and your mother, they will contact you to schedule your first study visit.
First Study Visit:
If you live within 60 miles of the clinic, you will be asked to come in for an in-person appointment that lasts about 1 hour. During this visit, the study staff will measure your height, weight, blood pressure, and your waist (using a tape measure).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •DCIS or Stage I-IIIA Breast Cancer (MOTHERS)
- •Have a biological daughter at least 21 years old (MOTHERS)
- •Body Mass Index between 25 - 40 (MOTHERS) or 25 or above (DAUGHTERS)
- •English Speaking & Writing (MOTHERS & DAUGHTERS)
- •5th grade or higher educational level (MOTHERS & DAUGHTERS)
- •Willingness to be randomized into the standardized or tailored intervention arms and to undergo baseline and follow-up assessments (MOTHERS & DAUGHTERS)
- •Must be at least 21 years of age (MOTHERS & DAUGHTERS)
- •Must reside within the United States, Puerto Rico or Guam and therefore able to participate in home visits made by Examination Management Services, Inc. (MOTHERS & DAUGHTERS)
排除标准
- •Evidence of progressive breast cancer or 2nd primaries (MOTHERS)
- •Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program or to a diet high in fruits and vegetables, such as the following: untreated stage 3 hypertension; severe orthopedic conditions; scheduled for a hip or knee replacement within 6 months; paralysis; end-stage renal disease; dementia; unstable angina; heart attack, congestive heart failure or pulmonary conditions that have required hospitalization or oxygen within 6 months (MOTHERS & DAUGHTERS)
- •Currently exercising 30+ minutes/day for 5+ days/week (<150 minutes per week) (MOTHERS & DAUGHTERS)
- •Currently enrolled in a weight loss program (MOTHERS & DAUGHTERS)
- •Residing in institutionalized settings, e.g., living in assisted or skilled nursing facilities, and therefore not able to make independent choices about their lifestyle behaviors and participate fully in the intervention (MOTHERS AND DAUGHTERS).
- •Currently pregnant (MOTHERS & DAUGHTERS)
- •A previous diagnosis of breast cancer (DAUGHTERS).
结局指标
主要结局
Overall Accrual
时间窗: 12-Months
次要结局
未报告次要终点