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

Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 65 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 4 weeks, 8 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the MIND healthy eating plan can ease “chemobrain” (memory and thinking problems) and other symptoms during cancer treatment. It is for women ages 40–65 with triple negative breast cancer; the study description says stages II–III, but the entry rules list stages I–III. Women are assigned by chance to 12 weeks of online eating-plan sessions or general health coaching, with follow-up 6 months later.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female and age 40–65.
  • Have stage I–III triple negative breast cancer, a type that lacks three common cancer markers.
  • Started your first whole-body cancer treatment within the past 12 months, such as chemotherapy or treatment that helps your immune system fight cancer.
  • Can access and use the internet, including Zoom video calls.
  • Speak English.

Who can't join

  • Have a history of dementia, stroke, brain injury, cancer that spread to the brain, or another condition that could affect memory or thinking.
  • Already follow a healthy eating pattern with a high MIND diet score, such as above 12.
  • Cannot or will not eat more than two types of MIND foods or food groups, such as leafy greens, olive oil, or non-fried fish.
  • Are pregnant.
  • Cannot give informed consent, meaning you cannot understand the study and agree to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

CT

OH