跳至主要内容
临床试验/NCT06412874
NCT06412874进行中(未招募)不适用

Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
210
试验地点
1
主要终点
The Bladder Cancer Need Assessment Survey (BCNAS)

研究概览

简要总结

The overall goal of this study is to facilitate care improvements for bladder cancer patients with locally advanced or metastatic disease by designing and evaluating a patient need assessment screening tool to be used, in the future, as standard screening measure. Adult individuals diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer will be included in this study and asked to participate in a focus group, complete a screening tool, or complete a survey. All data collected will be linked to a study ID number and HIPAA identifiers will not be linked to study data. Identifying information (ie: name, mrn, email, phone number) will be utilized for study recruitment and identifying eligible patients. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are eligible to participate if they are diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer
  • between 18 years and older (18-89 years)
  • have initiated any systemic treatment for advanced urothelial carcinoma
  • speak English speaking and are able to consent.

排除标准

  • Have a diagnosis of another advanced cancer that has required systemic therapy
  • Or have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements.

结局指标

主要结局

The Bladder Cancer Need Assessment Survey (BCNAS)

时间窗: 2023-2025

The Bladder Cancer Need Assessment Survey (BCNAS) includes 8 subscales: psychological, informational, care and support, logistic, sexuality, physical and daily living, communication with providers; and communication with social partners/family All subscales scored 0-100. Full scale scored from 0- 100. Higher score mean higher levels of unmeet needs. This is a measure of unmet needs.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nihal E Mohamed

Nihal Mohamed, Associate Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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