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

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

Conditions

• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Triple-Negative Breast Carcinoma

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

Sponsors & Collaborators

• American Institute for Cancer Research

  collaborator OTHER

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Tonya Orchard, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-28

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations