Intravesical Treatment of Bladder Cancer at Home, Multi-modal Treatment Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of adherence to BCG therapy at 3 months after study initiation
研究概览
简要总结
The proposed project will have two separate cohorts. The first will be to perform a more in-depth qualitative assessment of the barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer. The second arm will be to create and test a BCG at home program. Participants in the second cohort will be enrolled in a conversational agent to measure patient symptoms and quality of life and improve self-efficacy.
详细描述
The proposed project will have two separate cohorts. The first will be to perform a more in-depth qualitative assessment of the barriers and facilitators for treatment compliance for non-muscle invasive bladder cancer. The second arm will be to create and test a BCG at home program. Participants in the second cohort will be enrolled in a conversational agent to measure patient symptoms and quality of life and improve self-efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Inclusion criteria for patients in Cohort 1
- •Age 18 years or older;
- •completed intravesical treatment for non-muscle invasive bladder cancer within the past year Cohort 1 inclusion criteria for key stakeholders
- •Age 18 years or older;
- •experience with the delivery of BCG delivery for more than 2 years
- •Cohort 2 inclusion criteria
- •Age 18 years or older;
- •diagnosed with non-muscle invasive bladder cancer and prescribed BCG for initial therapy
排除标准
- •Cohort 1 exclusion criteria
- •inability to provide informed consent
- •Cohort 2 exclusion criteria
- •inability to provide informed consent
- •inability to undergo catheterization (i.e. - history of urethral stricture)
- •inability to receive BCG therapy (i.e. - previous reaction with BCG)
- •no access to mobile phone
- •inability to respond to written conversations in English
结局指标
主要结局
Rate of adherence to BCG therapy at 3 months after study initiation
时间窗: 3 months after study initiation
The primary outcome will be the rate of adherence to AUA guidelines for BCG therapy as measured by successful treatments of BCG compared to expected treatments. For each participant, adherence will be calculated both as the percentage of adherent doses, evaluable for study participants
次要结局
- • Self efficacy as measured by the validated General Self efficacy scale, a 10-item scale, measured at 3 months after study initiation(3 months after study initiation)
研究者
Daniel Lee, MD, MS
Principal Investigator
University of Pennsylvania