Actively Recruiting
Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-12-11
60
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
A
American Institute for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 65 years
- Female with stage I-III triple negative breast cancer
- Started initial systemic cancer treatment for TNBC within the past 12 months
- Ability to use internet and video calls via Zoom
- English speaking
You will not qualify if you...
- History of dementia, stroke, traumatic brain injury, brain metastasis, or other cognitive impairing conditions
- Currently following a healthy eating pattern with a high MIND diet score (above 12)
- Unwilling or unable to eat more than 2 types of MIND foods (e.g., avoids leafy greens, olive oil, non-fried fish)
- Currently pregnant
- Unable to give informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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