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NCT Number: NCT07018986

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

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Brent Small, PhD

SUB_INVESTIGATOR

Ellie Hu, PhD

SUB_INVESTIGATOR

Heather Jim, PhD

SUB_INVESTIGATOR

Hyo Han, MD

SUB_INVESTIGATOR

Sylvia Crowder, PhD

PRINCIPAL_INVESTIGATOR

Tiffany Carson, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIND Diet

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.

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

Usual diet

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.

Primary outcomes

  1. Efficacy of the MIND diet: Self-reported cognition

    Time frame: At 12 weeks and 3 months

    The Functional Assessment of Cancer Therapy - General (FACT-G) will be used to determine self-reported cognition.

Secondary outcomes

  1. Efficacy of the MIND diet: Fatigue

    Time frame: At 12 weeks and 3 months

    The Functional Assessment of Chronic Illness Fatigue Subscale (FACIT Fatigue) will be used to determine fatigue.

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

    Time frame: At 12 weeks and 3 months

    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients Questionnaire will be used to determine QOL and mood.

  3. Efficacy of the MIND diet: Objective cognition

    Time frame: At Baseline, 12 weeks, and 3 months

    Neuropsychological tests (i.e., best objective performance) will be administered via the CANTAB Connect (Cambridge Cognition, Cambridge, UK) that contains a well-validated battery of tests based in neuropsychology and neuroscience administered in a semi-automated manner via the web that is automatically scored upon completion. EMA Participants will complete 3 prompted surveys and sets of EMA cognitive tasks throughout the day as well as an end of day survey each day for 7 days at baseline, 12 weeks, and 3 month follow-up including symbol search, dot memory test, shopping list associate test. All scores will be correlated to determine objective cognition.

Study contacts

Contact information is provided by the study sponsor or research team.

Crystal Bryant

CONTACT

[email protected]

813-745-2168

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: MIND-BC

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jun 13, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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