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RECRUITING
NCT06582615
NA

Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo dried blood spot collection

PROCEDURE

Cognitive Assessment

Ancillary studies

OTHER

Dietary Intervention

Receive MIND counseling sessions

OTHER

Dietary Intervention

Follow a personalized diet

OTHER

Dietary Intervention

Receive general health recommendations counseling sessions

OTHER

Medical Device Usage and Evaluation

Wear a Fitbit

OTHER

Questionnaire Administration

Ancillary studies

Locations (2)

Yale University

New Haven, Connecticut, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States