NCT07018986

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
47mo left

Started Jul 2025

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jul 2025Mar 2030

First Submitted

Initial submission to the registry

May 28, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

July 9, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3.6 years

First QC Date

May 28, 2025

Last Update Submit

February 3, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    At 12 weeks and 3 months

Secondary Outcomes (3)

  • Efficacy of the MIND diet: Fatigue

    At 12 weeks and 3 months

  • Efficacy of the MIND diet: Quality of life (QOL) and mood

    At 12 weeks and 3 months

  • Efficacy of the MIND diet: Objective cognition

    At Baseline, 12 weeks, and 3 months

Study Arms (2)

MIND Diet Arm

EXPERIMENTAL

Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The MIND diet arm will be asked to participate in weekly "check-in" sessions with a diet coach supervised by a registered dietitian. To evaluate the longer-term effects of the MIND diet as a part of lifestyle change, we will also conduct a 3-month follow-up assessment.

Other: MIND Diet

Usual Diet Arm

ACTIVE COMPARATOR

Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The usual diet participants will be provided with weekly grocery gift cards to purchase foods that follow their "usual" diet. Usual diet participants will also conduct a 3-month follow-up assessment.

Other: Usual Diet

Interventions

MIND DietOTHER

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.

Also known as: The "Mediterranean-DASH Intervention for Neurodegenerative Delay" (MIND) diet
MIND Diet Arm
Usual DietOTHER

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.

Usual Diet Arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Sylvia Crowder

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Bryant

CONTACT

813-745-2168Crystal.Bryant@moffitt.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 13, 2025

Study Start

July 9, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2030

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

US(1)