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

NCT ID: NCT07018986

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-09
• Study Completion Date: 2030-03-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MIND Diet Arm

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.

Group Type: EXPERIMENTAL

MIND Diet

Intervention Type: OTHER

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.

Usual Diet Arm

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.

Group Type: ACTIVE_COMPARATOR

Usual Diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

The "Mediterranean-DASH Intervention for Neurodegenerative Delay" (MIND) diet

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Crowder

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Crystal Bryant

Role: CONTACT

Crystal.Bryant@moffitt.org

813-745-2168

Other Identifiers

R01CA299480

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-23571

Identifier Type: -

Identifier Source: org_study_id