The MIND-BC Study: MIND Diet for Breast Cancer Cognition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Efficacy of the MIND diet: Self-reported cognition
研究概览
简要总结
This fully, powered efficacy RCT, the MIND diet for Breast Cancer Cognition (MIND-BC), will evaluate the MIND diet in a rigorous, highly controlled academic cancer center. We will recruit breast cancer survivors reporting CRCI with a MIND diet score < 8, based on a previously devised 14-item diet questionnaire designed to detect inadequate diet with respect to brain health (scores range from 0 to 14, with lower scores indicating a less adequate diet).14 Breast cancer survivors will have recently completed adjuvant treatment (i.e., 6 months to three years previously), to ensure that perceived cognitive impairment is likely chronic and due to cancer. To achieve maximal effect, the study consists of two 12-week phases 1) intervention phase, 2) maintenance phase.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed with stage I-III breast cancer.
- •Able to speak and read English.
- •Able to consume foods orally.
- •>18 years of age.
- •Able to provide informed consent.
- •Have no documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., schizophrenia).
- •Report 'somewhat' to 'very much' cognitive impairment in the past week (i.e., a score ≥ 2 on a 0-4 scale) that they attribute to cancer or its treatment.
- •Report a MIND diet score < 10 (range 0 to 14, higher score equates to higher diet quality).
- •Willing to consume the MIND diet.
- •Completed adjuvant treatment 6 months to three years previously.
排除标准
- •Not meeting all of the inclusion criteria.
研究组 & 干预措施
MIND Diet Arm
Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The MIND diet arm will be asked to participate in weekly "check-in" sessions with a diet coach supervised by a registered dietitian. To evaluate the longer-term effects of the MIND diet as a part of lifestyle change, we will also conduct a 3-month follow-up assessment.
干预措施: MIND Diet (Other)
Usual Diet Arm
Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The usual diet participants will be provided with weekly grocery gift cards to purchase foods that follow their "usual" diet. Usual diet participants will also conduct a 3-month follow-up assessment.
干预措施: Usual Diet (Other)
结局指标
主要结局
Efficacy of the MIND diet: Self-reported cognition
时间窗: At 12 weeks and 3 months
The Functional Assessment of Cancer Therapy - General (FACT-G) will be used to determine self-reported cognition.
次要结局
- Efficacy of the MIND diet: Fatigue(At 12 weeks and 3 months)
- Efficacy of the MIND diet: Quality of life (QOL) and mood(At 12 weeks and 3 months)
- Efficacy of the MIND diet: Objective cognition(At Baseline, 12 weeks, and 3 months)