Clinical Trial 23571
- Cancer Type: Breast
- Study Type: Supportive Care
- NCT#: NCT07018986
- Phase: N/A
- Principal Investigator: Crowder, Sylvia
- 813-745-6100
- Or 1-800-679-0775
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Overview
Study Title:
The MIND-BC Study: MIND Diet for Breast Cancer Cognition
Objective:
Aim 1: To evaluate the efficacy of the MIND diet in reducing self-reported cancer-related cognitive impairment (primary outcome) in early-stage breast cancer survivors. Aim 2: To evaluate the efficacy of the MIND diet in improving objective cancer-related cognitive impairment (i.e., best objective performance and usual objective performance), fatigue, mood, and QOL (secondary outcomes) in early-stage breast cancer survivors. Exploratory Aim 3: To explore putative mechanisms of improvements in cognition secondary to the MIND diet (inflammatory biomarkers, body composition, nutrient biomarkers, etc.) versus controls.
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Inclusion Criteria
- Key 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 ≥ 3 on a 1-5 scale) that they attribute to cancer or its treatment.
- Report a MIND diet score > Willing to consume the MIND diet.
- Completed adjuvant treatment 6 months to three years previously.
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Exclusion Criteria
- Key Exclusion Criteria:
- Not meeting all of the inclusion criteria.
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