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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07018986
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-08
• Primary Completion: 2029-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 ≥ 3 on a 1-5 scale) that they attribute to cancer or its treatment.
• Report a MIND diet score < 8 (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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy of the MIND diet: Fatigue	At 12 weeks and 3 months	The Functional Assessment of Chronic Illness Fatigue Subscale (FACIT Fatigue) will be used to determine fatigue.
Efficacy of the MIND diet: Quality of life (QOL) and mood	At 12 weeks and 3 months	The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients Questionnaire will be used to determine QOL and mood.
Efficacy of the MIND diet: Objective cognition	At Baseline, 12 weeks, and 3 months	Neuropsychological tests (i.e., best objective performance) will be administered via the CANTAB Connect (Cambridge Cognition, Cambridge, UK) that contains a well-validated battery of tests based in neuropsychology and neuroscience administered in a semi-automated manner via the web that is automatically scored upon completion. EMA Participants will complete 3 prompted surveys and sets of EMA cognitive tasks throughout the day as well as an end of day survey each day for 7 days at baseline, 12 weeks, and 3 month follow-up including symbol search, dot memory test, shopping list associate test. All scores will be correlated to determine objective cognition.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States