The MIND-BC Study: MIND Diet for Breast Cancer Cognition
Recruiting · NCT07018986 · Interventional (participants receive a specific treatment) · Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Moffitt Cancer Center - Tampa, Florida, United States