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

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: MIND Diet; Other: Usual Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07018986

R01CA299480 (U.S. NIH Grant/Contract)

MCC-23571

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

MIND Diet Arm

Experimental group

Description:

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.

Treatment:

Other: MIND Diet

Usual Diet Arm

Active Comparator group

Description:

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.

Treatment:

Other: Usual Diet