Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention with Mediterranean Diet
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).
干预措施: Mediterranean diet-based Intervention (Behavioral)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: 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
次要结局
未报告次要终点