Trials Today

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

Purpose

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.

Condition

Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	Other: 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. Other names: The "Mediterranean-DASH Intervention for Neurodegenerative Delay" (MIND) diet
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.	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.

Recruiting Locations

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612

More Details

NCT ID: NCT07018986
Status: Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.