Breast Cancer
Conditions
Brief summary
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.
Interventions
OTHERMIND 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.
OTHERUsual 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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the MIND diet: Self-reported cognition | At 12 weeks and 3 months | The Functional Assessment of Cancer Therapy - General (FACT-G) will be used to determine self-reported cognition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the MIND diet: Quality of life (QOL) and mood | 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. |
| Efficacy of the MIND diet: Fatigue | At 12 weeks and 3 months | The Functional Assessment of Chronic Illness Fatigue Subscale (FACIT Fatigue) will be used to determine fatigue. |
| Efficacy of the MIND diet: Objective cognition | 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. |
Countries
United States
Contacts
CONTACTCrystal Bryant
PRINCIPAL_INVESTIGATORSylvia Crowder
Moffitt Cancer Center
Outcome results
None listed