This clinical trial tests whether a virtual dietary intervention (the Mediterranean-DASH Intervention for Neurodegenerative Delay [MIND] - Breast Cancer [BC] diet) works to reduce cancer-related cognitive impairment in women undergoing treatment for stage II-IV breast cancer. Patients undergoing treatment for cancer often experience side effects that reduce their quality of life. Cancer-related cognitive impairment is one of the most common and serious side effects associated with cancer treatment. The MIND diet targets ten key food groups that have been shown to be protective of cognitive function (leafy greens, other vegetables, beans, whole grains, berries, nuts, non-fried fish, non-fried poultry, olive and canola oils, and wine). Patients receiving the MIND-BC diet intervention are taught specific behavior change techniques to address self-efficacy, self-monitoring, social support, goal setting, and removing barriers to support healthy eating patterns. The virtual MIND-BC dietary intervention may be an effective and accessible option for reducing cognitive impairment in women undergoing treatment for stage II-IV breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05984888.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Tonya Orchard
Phone: 614-292-7241
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of a remotely delivered, highly accessible, 12-week MIND diet intervention (MIND-BC) versus General Health Curriculum (GHC) control to reduce cancer-related cognitive impairment (CRCI) symptoms in diverse women newly diagnosed with invasive BC starting systemic therapies.
II. Evaluate the sustainability of dietary changes and outcome measures 6-months post-intervention.
EXPLORATORY OBJECTIVE:
I. Explore underlying mechanisms of the MIND-BC diet on CRCI.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend virtual MIND-BC sessions with a registered dietitian nutritionist over 15-60 minutes once a week (QW) in weeks 1-4, 6, 8, 10, and 12, for a total of 8 sessions. Patients also wear a Fitbit and undergo collection of dried blood spot samples throughout the study.
ARM II: Patients attend virtual GHC sessions over 15-60 minutes QW in weeks 1-4, 6, 8, 10, and 12, for a total of 8 sessions. Patients also wear a Fitbit and undergo collection of dried blood spot samples throughout the study.
After completion of study intervention, patients are followed up for 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorTonya Orchard