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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-02780 | Other Identifier | NCI-CTRP Clinical Registry |
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This study, we will build upon our prior work and test the feasibility of a Mediterranean diet intervention for medically underserved men with prostate cancer seen at LBJ Hospital, a large safety net facility in Harris County, TX.
Primary Objectives:
To determine the feasibility of a Mediterranean diet-based intervention adapted for underrepresented minority men with prostate cancer, defined based on the following process measures68:
Secondary Objectives:
To determine changes due to the Mediterranean diet intervention in the following measures:
To determine fidelity of intervention,62 including a description of patient comprehension, cognitive skills and perceived ability to change diet during the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention with Mediterranean Diet | Experimental | Twenty-five (25) self-identified Black and/or Hispanic men with newly diagnosed (within 6 months) localized PCa or who have been managed on active surveillance for less than 5 years will be enrolled along with their spouses (if applicable). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet-based Intervention | Behavioral | Through existing collaboration with the Harris Health system's innovative food pharmacy, participants will be provided fresh fruit, vegetables and other foods every other week during the study. Participants will receive olive oil and walnuts during the 8 week intervention (consistent with the PREDIMED6 intervention) to supplement their (and their families') diet during the 8-week intervention (while personalized education about diet, food choices and preparation is still occurring). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse Events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Males
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| Name | Affiliation | Role |
|---|---|---|
| Justin Gregg, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon B Johnson Hospital | Houston | Texas | 77026 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |