Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer (MIND-TNBC)

Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Cognitive Assessment; Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Dietary Intervention; Other: Dietary Intervention; Other: Medical Device Usage and Evaluation

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the efficacy of a remotely delivered, highly accessible, 3-month MIND diet intervention (MIND-Breast Cancer [BC]) versus (vs.) general health curriculum (GHC) control to reduce CRCI and associated neuropsychological symptoms in 60 racially and ethnically diverse women with clinical stage II-III TNBC.

II. Evaluate the sustainability of dietary changes and outcome measures 6-months post-intervention.

EXPLORATORY OBJECTIVE:

I. Explore underlying mechanisms of the MIND-BC diet on CRCI and effects of early versus later participation in the dietary intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.

ARM II: Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.

After completion of study intervention, patients are followed up at 6 months.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale University
      • Contact: Maryam Lustberg, MD, MPH; Phone Number: 203-200-2328; Email: maryam.lustberg@yale.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Tonya Orchard, PhD; Phone Number: 614-292-7241; Email: Orchard.6@osu.edu
      • Principal Investigator: Tonya Orchard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 40-65 years
• Female with stage I-III triple negative breast cancer
• Less than or equal to 12 months from starting initial systemic cancer treatment (e.g. chemotherapy, targeted therapy, immunotherapy) for TNBC
• Ability to access and use internet resources, including video calls using Zoom platform
• English speaking

Exclusion Criteria:

• History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment
• Current healthy eating pattern reflected by high MIND diet score (e.g. >12)
• Unwilling/unable to eat > 2 types of MIND food (e.g. avoids & > 2 categories or food groups such as leafy greens, olive oil and non-fried fish)
• Currently pregnant
• Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (MIND-TNBC counseling); Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.	Other: Questionnaire Administration; Ancillary studies; Procedure: Cognitive Assessment; Ancillary studies; Procedure: Biospecimen Collection; Undergo dried blood spot collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Dietary Intervention; Receive MIND counseling sessions; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Dietary Intervention; Follow a personalized diet; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Dietary Intervention; Receive general health recommendations counseling sessions; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Medical Device Usage and Evaluation; Wear a Fitbit
Active Comparator: Arm II (general health recommendations counseling); Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.	Other: Questionnaire Administration; Ancillary studies; Procedure: Cognitive Assessment; Ancillary studies; Procedure: Biospecimen Collection; Undergo dried blood spot collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Dietary Intervention; Receive MIND counseling sessions; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Dietary Intervention; Follow a personalized diet; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Dietary Intervention; Receive general health recommendations counseling sessions; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Other: Medical Device Usage and Evaluation; Wear a Fitbit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score	Analyses of change in WAIS-IV test scores will be based on a linear or generalized linear mixed effects regression model, as appropriate. Timepoint, treatment assignment, and their interaction will be included as fixed effects, and a subject-level random intercept effect will be included to account for correlation of repeated measurements from the same subject. Pathological complete response and baseline measurements of the outcome variables will also be included as fixed effects to improve precision, as will any demographic variables that are substantially imbalanced at baseline. Will report descriptive statistics, and when applicable, comparisons between randomized groups.	Baseline up to 6 months post-intervention

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: American Institute for Cancer Research
• Investigators: Principal Investigator: Tonya Orchard, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Behavioral Disciplines and Activities; Nutrition Therapy; Psychological Tests; Neuropsychological Tests; Specimen Handling; Diet Therapy; Mental Status and Dementia Tests
• Other Study ID Numbers: OSU-23384; NCI-2024-05451 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No