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Clinical Trials/NCT06412874
NCT06412874
Active, not recruiting
Not Applicable

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 site in 1 country210 target enrollmentMay 20, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Screening Tool
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
210
Locations
1
Primary Endpoint
The Bladder Cancer Need Assessment Survey (BCNAS)
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2025
End Date
October 31, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nihal E Mohamed

Nihal Mohamed, Associate Professor

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

The Bladder Cancer Need Assessment Survey (BCNAS)

Time Frame: 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.

Study Sites (1)

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