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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA299480 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIND Diet Arm | Experimental | 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. |
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| Usual Diet Arm | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the MIND diet: Self-reported cognition | The Functional Assessment of Cancer Therapy - General (FACT-G) will be used to determine self-reported cognition. | At 12 weeks and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the MIND diet: Fatigue | The Functional Assessment of Chronic Illness Fatigue Subscale (FACIT Fatigue) will be used to determine fatigue. | At 12 weeks and 3 months |
| Efficacy of the MIND diet: Quality of life (QOL) and mood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystal Bryant | Contact | 813-745-2168 | Crystal.Bryant@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Sylvia Crowder | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42173439 | Derived | Crowder SL, Hu B, Hoogland AI, Li X, Rodriguez Y, Bryant C, Varghese DM, Simon DF, Reese SA, Carson TL, Han HS, Small BJ, Jim HSL. Rationale and study protocol for a randomized controlled MIND diet feeding trial for breast cancer-related cognitive impairment. Contemp Clin Trials. 2026 Jul;166:108355. doi: 10.1016/j.cct.2026.108355. Epub 2026 May 22. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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. |
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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.
| At 12 weeks and 3 months |
| Efficacy of the MIND diet: Objective cognition | 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. | At Baseline, 12 weeks, and 3 months |
| D017437 |
| Skin and Connective Tissue Diseases |