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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Crystal Bryant
Crystal.Bryant@moffitt.org
813-745-2168
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2030-03
Participants
Target number of participants: 200
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov