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. |
|
|
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. |
|
Recruiting Locations
Tampa 4174757, Florida 4155751 33612
More Details
- NCT ID
- NCT07018986
- Status
- Recruiting
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute