Actively Recruiting
Food for Thought - Pilot Study of a MIND Diet Intervention in 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
4 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
Researchers are studying whether a healthy eating plan called the MIND diet can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other symptoms like fatigue, sleep quality, anxiety, and depression in women newly diagnosed with stage II-III triple negative breast cancer undergoing chemotherapy. This randomized clinical trial compares the effects of the MIND eating plan to a general health coaching program, aiming to see if the MIND diet helps improve memory and mental function. The study also explores how lasting these effects are six months after the intervention. Participants are randomly assigned to one of two groups. One group receives personalized MIND diet counseling through weekly sessions for four weeks, then biweekly sessions for eight weeks, while following the diet for 12 weeks. The other group receives general health coaching with a similar session schedule. Both groups wear Fitbits to monitor activity and provide dried blood spot samples during the study and follow-up. After six months, those initially in the general health group can choose to receive the MIND diet counseling. Throughout the study, all sessions and assessments are done remotely, including online questionnaires and virtual visits. Women attend eight virtual sessions lasting 15 to 60 minutes over 12 weeks and receive some key MIND diet foods by mail if in that group. Researchers measure changes in cognitive function using the Wechsler Adult Intelligence Scale Digit Span test from the start through six months post-intervention. The study lasts about nine months for each participant, including intervention and follow-up periods.
CONDITIONS
Brief 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 triple negative breast cancer within the last 12 months
- Able to access and use internet resources including video calls on Zoom
- English speaking
You will not qualify if you...
- History of dementia, stroke, traumatic brain injury, brain metastasis, or other conditions causing cognitive impairment
- Currently following a healthy eating pattern with a high MIND diet score (greater than 12)
- Unwilling or unable to eat more than 2 types of MIND diet foods (e.g., avoids more than 2 categories like leafy greens, olive oil, or non-fried fish)
- Currently pregnant
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 12 weeks
Participants receive counseling sessions and follow a personalized diet or general health recommendations while wearing a Fitbit and undergoing dried blood spot collection.
Weekly counseling visits for 4 weeks, then biweekly visits for 8 weeks
Duration - 6 months
Participants are followed up to assess sustainability of dietary changes and outcomes 6 months after intervention completion, including wearing a Fitbit and dried blood spot collection.
Periodic follow-up visits during 6 months post-intervention
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
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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