NCT07018986 · H. Lee Moffitt Cancer Center and Research Institute
The MIND-BC Study: MIND Diet for Breast Cancer Cognition
(MIND-BC)
What this study is about
This fully, powered effectiveness RCT, the MIND diet for Breast Cancer Cognition (MIND-BC), will evaluate the MIND diet in a rigorous, highly controlled academic cancer center.
View original scientific description
This fully, powered efficacy RCT, the MIND diet for Breast Cancer Cognition (MIND-BC), will evaluate the MIND diet in a rigorous, highly controlled academic cancer center. We will recruit breast cancer survivors reporting CRCI with a MIND diet score \< 8, based on a previously devised 14-item diet questionnaire designed to detect inadequate diet with respect to brain health (scores range from 0 to 14, with lower scores indicating a less adequate diet).14 Breast cancer survivors will have recently completed adjuvant treatment (i.e., 6 months to three years previously), to ensure that perceived cognitive impairment is likely chronic and due to cancer. To achieve maximal effect, the study consists of two 12-week phases 1) intervention phase, 2) maintenance phase.
Interventions
OTHER
MIND Diet
a combination of the Mediterranean and DASH diets emphasizing consumption of high-nutrient, plant-based foods such as green leafy vegetables, nuts, berries, fish, and olive oil while limiting intake of foods high in saturated fat, pre-processed snacks, sugar, red and processed meat.
OTHER
Usual Diet
Check-in sessions for the usual diet arm will focus on general health (e.g., healthy hair, skin, eyesight). None of the topics will include dietary information for the usual diet arm.
Primary outcome measures
Efficacy of the MIND diet: Self-reported cognition
Time frame: At 12 weeks and 3 months
The Functional Assessment of Cancer Therapy - General (FACT-G) will be used to determine self-reported cognition.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Previously diagnosed with stage I-III breast cancer.
- Able to speak and read English.
- Able to consume foods orally.
- \>18 years of age.
- Able to provide informed consent.
- Have no documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., schizophrenia).
- Report 'somewhat' to 'very much' cognitive impairment in the past week (i.e., a score ≥ 2 on a 0-4 scale) that they attribute to cancer or its treatment.
- Report a MIND diet score \< 10 (range 0 to 14, higher score equates to higher diet quality).
- Willing to consume the MIND diet.
- Completed adjuvant treatment 6 months to three years previously.
Exclusion criteria
- Not meeting all of the inclusion criteria.
Where
- Tampa, Florida
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations