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
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
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
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo dried blood spot collection
Cognitive Assessment
Procedure/SurgeryAncillary studies
Dietary Intervention
Other interventionReceive MIND counseling sessions
Dietary Intervention
Other interventionFollow a personalized diet
Dietary Intervention
Other interventionReceive general health recommendations counseling sessions
Medical Device Usage and Evaluation
Other interventionWear a Fitbit
Questionnaire Administration
Other interventionAncillary studies
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.
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Ohio State University Comprehensive Cancer Center
Lead sponsor
American Institute for Cancer Research
Collaborator
