Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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: * Enrollment (completion of 25 patient accrual within 2 years) * Retention (completion of the study through the 6-month time point, with ≥80% defined as successful) * Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful). Secondary Objectives: To determine changes due to the Mediterranean diet intervention in the following measures: * Mediterranean diet score (define using MEPA I calculated using VioScreen data) * Weight/BMI * QoL (EQ-5D-5L) * Physical activity (IPAS) * Non-invasive biomarkers * Gut microbiome * Metabolomics To determine fidelity of intervention,62 including a description of patient comprehension, cognitive skills and perceived ability to change diet during the intervention.
Interventions
BEHAVIORALMediterranean diet-based Intervention
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).
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the prostate that is localized based on metastatic workup ordered by the treating physician (which may include CT scan, bone scan, MRI and/or other imaging). Note that metastatic workup is not required for enrollment. * Diagnosis within 12 months prior to enrollment OR * Currently managed on active surveillance, with initial biopsy being \<5 years from date of enrollment * Self-identified Hispanic and/or Black/African American * Patient at LBJ Hospital
Exclusion criteria
* Special dietary requirements such that patient is unwilling to attempt dietary change * Unwillingness to participate in study activities * Inability to keep appointments * Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJustin Gregg, MD
M.D. Anderson Cancer Center
Outcome results
None listed