Actively Recruiting

Phase Not Applicable
Age: 40Years - 65Years
FEMALE
NCT06582615

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

Age: 40Years - 65Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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