RecruitingInterventional

The MIND-BC Study: MIND Diet for Breast Cancer Cognition

NCT ID: NCT07018986Sponsor: H. Lee Moffitt Cancer Center and Research InstituteLast updated: 2026-02-05

Summary

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.

Arms & interventions

OtherMIND 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.
OtherUsual 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.

Outcome measures

Primary

Efficacy of the MIND diet: Self-reported cognition
The Functional Assessment of Cancer Therapy - General (FACT-G) will be used to determine self-reported cognition.
Time frame: At 12 weeks and 3 months

Secondary

Efficacy of the MIND diet: Fatigue
Time frame: At 12 weeks and 3 months
Efficacy of the MIND diet: Quality of life (QOL) and mood
Time frame: At 12 weeks and 3 months
Efficacy of the MIND diet: Objective cognition
Time frame: At Baseline, 12 weeks, and 3 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

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.

Study locations (1)

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Sylvia Crowder, PhD · Principal Investigator

Heather Jim, PhD · Sub Investigator

Tiffany Carson, PhD · Sub Investigator

Hyo Han, MD · Sub Investigator

Ellie Hu, PhD · Sub Investigator

Brent Small, PhD · Sub Investigator

References

Crowder SL, Hu B, Hoogland AI, Li X, Rodriguez Y, Bryant C, Varghese DM, Simon DF, Reese SA, Carson TL, Han HS, Small BJ, Jim HSL. Rationale and study protocol for a randomized controlled MIND diet feeding trial for breast cancer-related cognitive impairment. Contemp Clin Trials. 2026 May 21:108355. doi: 10.1016/j.cct.2026.108355. Online ahead of print.(PubMed)