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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorOhio State University Comprehensive Cancer Center

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Cognitive Assessment
  • Dietary Intervention
  • Dietary Intervention
  • Dietary Intervention
  • Medical Device Usage and Evaluation
  • Questionnaire Administration

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ohio State University Comprehensive Cancer Center

Lead sponsor

American Institute for Cancer Research

Collaborator