Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score
研究概览
简要总结
The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression.
Researchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions.
Women randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely.
Participants will:
- Be randomized to MIND or GHC interventions
- Complete all study measures remotely (by online questionnaires, virtual visits and mail )
- Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks
- Be sent some of the key foods in the MIND eating plan during the MIND intervention
- Be contacted for follow-up measures 6 months after interventions
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of a remotely delivered, highly accessible, 3-month MIND diet intervention (MIND-Breast Cancer [BC]) versus (vs.) general health curriculum (GHC) control to reduce CRCI and associated neuropsychological symptoms in 60 racially and ethnically diverse women with clinical stage II-III TNBC.
II. Evaluate the sustainability of dietary changes and outcome measures 6-months post-intervention.
EXPLORATORY OBJECTIVE:
I. Explore underlying mechanisms of the MIND-BC diet on CRCI and effects of early versus later participation in the dietary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 40-65 years
- •Female with stage I-III triple negative breast cancer
- •Less than or equal to 12 months from starting initial systemic cancer treatment (e.g. chemotherapy, targeted therapy, immunotherapy) for TNBC
- •Ability to access and use internet resources, including video calls using Zoom platform
- •English speaking
排除标准
- •History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment
- •Current healthy eating pattern reflected by high MIND diet score (e.g. >12)
- •Unwilling/unable to eat > 2 types of MIND food (e.g. avoids & > 2 categories or food groups such as leafy greens, olive oil and non-fried fish)
- •Currently pregnant
- •Unable to give informed consent
结局指标
主要结局
Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score
时间窗: Baseline up to 6 months post-intervention
Analyses of change in WAIS-IV test scores will be based on a linear or generalized linear mixed effects regression model, as appropriate. Timepoint, treatment assignment, and their interaction will be included as fixed effects, and a subject-level random intercept effect will be included to account for correlation of repeated measurements from the same subject. Pathological complete response and baseline measurements of the outcome variables will also be included as fixed effects to improve precision, as will any demographic variables that are substantially imbalanced at baseline. Will report descriptive statistics, and when applicable, comparisons between randomized groups.
次要结局
未报告次要终点
研究者
Tonya Orchard
Principal Investigator
Ohio State University Comprehensive Cancer Center