POW-R Health: Power to Redefine Your Health A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Urinary Isothiocyanates Levels
研究概览
简要总结
This phase I trial investigates how well a healthy eating program works in improving outcomes in patients with bladder cancer. The behavioral dietary program consists of educational materials, live phone calls, and interactive voice response phone messages. Participating in the healthy eating program may improve eating habits and/or reduce the risk of bladder cancer from coming back.
详细描述
PRIMARY OBJECTIVES:
I. Develop an evidence-based behavioral intervention to increase cruciferous vegetable intake, with the goal of attaining desirable urinary isothiocyanates (ITC) levels effective for anti-cancer activities.
II. Conduct a feasibility pilot of our dietary behavioral intervention through a hybrid I implementation randomized controlled design in 80 non-muscle invasive bladder cancer (NMIBC) survivors, where the treatment group (n=40) will receive an evidence-based telephone intervention to increase cruciferous vegetable intake and the control group (n=40) will receive a general fruit and vegetable intake intervention based on National Cancer Institute (NCI) guidelines.
SECONDARY OBJECTIVE:
I. To ascertain the level of gene expression changes in urinary exfoliated epithelial cells (due to the intervention) as a surrogate for intermediate efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CANCER PATIENT: Age 18 years old or older (no upper limit)
- •CANCER PATIENT: English speaking
- •CANCER PATIENT: Diagnosed with stage Tis, Ta, or T1 bladder cancer
- •CANCER PATIENT: Resides in the Western New York catchment area
- •CANCER PATIENT: Did not receive a partial or radical cystectomy
- •CANCER PATIENT: Does not have a prior cancer diagnosis within 12 months of their bladder cancer diagnosis
- •CANCER PATIENT: Does not have a subsequent more advanced bladder cancer diagnosis
- •CANCER PATIENT: For Roswell Park Cancer Registry only: Bladder cancer diagnosed 2016-2018, 2019-current
- •CANCER PATIENT: Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- •PHYSICIAN: English speaking
- •PHYSICIAN: Physician in a clinic located in the catchment area
- •PHYSICIAN: Currently treats bladder cancer patients
排除标准
- •CANCER PATIENT: Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •CANCER PATIENT: Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •CANCER PATIENT: Adults unable to consent
- •CANCER PATIENT: Adults unable to complete study measures in English
- •CANCER PATIENT: Individuals who are not yet adults (infants, children, teenagers)
- •CANCER PATIENT: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •CANCER PATIENT: Unwilling or unable to follow protocol requirements
- •PHYSICIAN: Unable to complete the study measures in English
结局指标
主要结局
Urinary Isothiocyanates Levels
时间窗: 6 months
Will be measured using high performance liquid chromatography (HPLC)-based cyclocondensation assay. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.
Cruciferae Intake Change
时间窗: 6 months
Will be assessed using a questionnaire adapted from Thomson et al. to capture both intake and cooking styles. The outcome is defined as change from baseline in measured levels. Between-group difference of change from baseline was analyzed using Wilcoxon rank-sum tests.
次要结局
- Gene Expression(6 months)
- Change in Cruciferous Vegetable Intake, Cups/Day(6 months)