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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-05451 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| American Institute for Cancer Research | OTHER |
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The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression.
Researchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions.
Women randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely.
Participants will:
PRIMARY OBJECTIVES:
I. Evaluate the efficacy of a remotely delivered, highly accessible, 3-month MIND diet intervention (MIND-Breast Cancer [BC]) versus (vs.) general health curriculum (GHC) control to reduce CRCI and associated neuropsychological symptoms in 60 racially and ethnically diverse women with clinical stage II-III TNBC.
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 and effects of early versus later participation in the dietary intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.
ARM II: Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.
After completion of study intervention, patients are followed up at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (MIND-TNBC counseling) | Experimental | Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. |
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| Arm II (general health recommendations counseling) | Active Comparator | Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo dried blood spot collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score | Analyses of change in WAIS-IV test scores will be based on a linear or generalized linear mixed effects regression model, as appropriate. Timepoint, treatment assignment, and their interaction will be included as fixed effects, and a subject-level random intercept effect will be included to account for correlation of repeated measurements from the same subject. Pathological complete response and baseline measurements of the outcome variables will also be included as fixed effects to improve precision, as will any demographic variables that are substantially imbalanced at baseline. Will report descriptive statistics, and when applicable, comparisons between randomized groups. | Baseline up to 6 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tonya Orchard, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06519 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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Parallel design with optional cross-over of the control group to the treatment group after 6-month follow-up.
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| Cognitive Assessment | Procedure | Ancillary studies |
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| Dietary Intervention | Other | Receive MIND counseling sessions |
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| Dietary Intervention | Other | Follow a personalized diet |
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| Dietary Intervention | Other | Receive general health recommendations counseling sessions |
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| Medical Device Usage and Evaluation | Other | Wear a Fitbit |
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| Questionnaire Administration | Other | Ancillary studies |
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| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D000073216 | Mental Status and Dementia Tests |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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