A Scalable Cruciferous Vegetable Intervention to Reduce Bladder Cancer Recurrence and Progression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 344
- 试验地点
- 2
- 主要终点
- Urinary isothiocyanates (ITCs) levels
研究概览
简要总结
This phase II trial is being done to develop and test a healthy eating program to reduce cancer recurrence (cancer that has come back after a period of improvement) and/or progression (cancer that is growing, spreading, or getting worse) in patients with non-muscle invasive bladder cancer (NMIBC). Researchers want to better understand how incorporating more cruciferous vegetables in the diet may reduce the risk of cancer recurrence or progression in men and women who were diagnosed with early-stage bladder cancer and compare whether extending the program can further improve bladder cancer outcomes. POW-R Health is a behavioral dietary intervention designed to modestly increase cruciferous vegetable (cruciferae) intake in patients. Cruciferous vegetables, such as cabbage, kale and broccoli, arugula, contain phytochemicals known as isothiocyanates (ITCs). Dietary ITCs exert potent anticancer activities against bladder cancer and can be rapidly metabolized, delivered to the bladder, and concentrated in the urine. Participating in the healthy eating program may reduce bladder cancer recurrence or progression in NMIBC survivors.
详细描述
PRIMARY OBJECTIVES:
I. Develop a maintenance component to add onto our POW-R Health intervention (POW-R Health Only/Core) to create POW-R Health + Maintenance.
II. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core using a 2-group randomized controlled trial (RCT) design in 344 participants on the primary outcome of urinary ITC.
SECONDARY OBJECTIVE:
I. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core on the secondary outcome of cruciferae intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Data Collector will be masked to treatment assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Diagnosed with stage Tis, Ta, or T1 bladder cancer
- •Age 18 years old or older (no upper limit)
- •Resides in New York State
- •Cancer not reported by a lab, nursing home, or death certificate/autopsy only
- •Did not receive a partial or radical cystectomy
- •Does not have other cancer diagnosis within 12 month of bladder cancer diagnosis except for cancers deemed low risk and unlikely to impact study participation (e.g., basal cell carcinoma, nor under active treatment for any other cancers
排除标准
- •Participants who 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
- •Adults unable to consent
- •Adults unable to complete study measures in English
- •Individuals who are not yet adults (infants, children, teenagers)
- •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
- •Unwilling or unable to follow protocol requirements
- •The following special populations ae excluded from this study:
- •Cognitively impaired adults/adults with impaired decision-making capacity
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Adaptation
CAB members participate in maintenance phase development discussion over an hour up to 3 times per week.
干预措施: Behavioral Dietary Intervention (Behavioral)
Arm II - POW-R Health Only/Core + Maintenance
Patients receive study materials and phone calls during life of study
干预措施: Telephone- Based Intervention (Behavioral)
结局指标
主要结局
Urinary isothiocyanates (ITCs) levels
时间窗: Baseline throughout life of study - up to 24 months
Levels with be measured using high performance liquid chromatography-based cyclocondensation assay
次要结局
- Increase in Cruciferae Intake(up to 24 months)