Prescription for Better Breast Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Achieve USDA-recommended dietary intake based on five major food groups
研究概览
简要总结
This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI] and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.
详细描述
The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females 18 years or older
- •Primary diagnosis of breast cancer
- •Fluency in English
- •B.M.I. >= 30
- •Available for follow-up for 12 months
排除标准
- •Clinical evidence of metastatic disease
- •Not diagnosed with primary breast cancer
- •Lack fluency in English
- •B.M.I. < 30
研究组 & 干预措施
Dietary Intervention
Participants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change.
干预措施: Dietary Intervention (Behavioral)
Dietary Control
Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.
干预措施: Dietary Control (Behavioral)
结局指标
主要结局
Achieve USDA-recommended dietary intake based on five major food groups
时间窗: 12 months
The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score ("yes" vs. "no") describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values.
Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up
时间窗: 12 months
We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values.
Comparison of Interleukin (IL) pro-inflammatory biomarkers
时间窗: 12 months
We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values.
Comparison of Interleukin (IL) anti-inflammatory biomarkers
时间窗: 12 months
We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values.
Comparison of C-Reactive Protein (CRP)
时间窗: 12 months
We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values.
Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)
时间窗: 12 months
We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values.
次要结局
未报告次要终点
研究者
Amelie Ramirez
Principal Investigator
The University of Texas Health Science Center at San Antonio