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Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
Sponsor: Ohio State University Comprehensive Cancer Center
Summary
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
Official title: Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer
Key Details
Gender
FEMALE
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-10-28
Completion Date
2026-12-31
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo dried blood spot collection
Cognitive Assessment
Ancillary studies
Dietary Intervention
Receive MIND counseling sessions
Dietary Intervention
Follow a personalized diet
Dietary Intervention
Receive general health recommendations counseling sessions
Medical Device Usage and Evaluation
Wear a Fitbit
Questionnaire Administration
Ancillary studies
Locations (2)
Yale University
New Haven, Connecticut, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States