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

NCT06412874 | Completed

• 1 other identifier: STUDY-23-00592
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Screening Tool; Focus Group

Outcome Measures

Primary Outcomes (1)

• The Bladder Cancer Need Assessment Survey (BCNAS)

  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.

  2023-2025

Study Arms (2)

Screening tool group

Other: Screening tool

Focus group

Interventions

Screening tool OTHER

Participants will complete a screening tool survey

Screening tool group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Bladder cancer survivors

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Pfizer: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Potentially Inappropriate Medication List

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nihal Mohamed, PhD

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nihal Mohamed, Associate Professor

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: May 14, 2024
• Study Start: May 20, 2025
• Primary Completion: August 9, 2025
• Study Completion: August 9, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)