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

RECRUITINGN/ASponsored by Ohio State University Comprehensive Cancer Center
Actively Recruiting
PhaseN/A
SponsorOhio State University Comprehensive Cancer Center
Started2024-10-28
Est. completion2026-12
Eligibility
Age40 Years – 65 Years
SexFEMALE
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT06582615

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

Age: 40 Years – 65 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions5

Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast CancerCancerTriple-Negative Breast Carcinoma

Locations2 sites

Connecticut

1 site
Yale University
New Haven, Connecticut, 06519
Maryam Lustberg, MD, MPH203-200-2328maryam.lustberg@yale.edu

Ohio

1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Tonya Orchard, PhD614-292-7241Orchard.6@osu.edu

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