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

Phase

N/A

Condition

Metastatic Triple-negative Breast Cancer

Treatment

Questionnaire Administration

Dietary Intervention

Medical Device Usage and Evaluation

Clinical Study ID

NCT06582615

OSU-23384

NCI-2024-05451

Ages 40-65
Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 40-65 years
Female with newly diagnosed stage II-III triple negative breast cancer
Within 3 weeks prior to starting neoadjuvant chemotherapy OR up to 6 months afterstarting neoadjuvant chemotherapy
Ability to access and use internet resources, including video calls using Zoomplatform
English speaking

Exclusion

Exclusion Criteria:

History of dementia, stroke, traumatic brain injury, brain metastasis or otherconditions that could lead to cognitive impairment
Current healthy eating pattern reflected by high MIND diet score (e.g. > 8)
Unwilling/unable to eat > 2 types of MIND food (e.g. avoids > 2 categories orfood groups such as leafy greens, olive oil and non-fried fish)
Currently pregnant
Unable to give informed consent

Study Design

Questionnaire Administration

October 28, 2024

December 31, 2026

Study 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.

Connect with a study center

Yale University
New Haven, Connecticut 06519
United States
Active - Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Active - Recruiting

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