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

NCT ID: NCT06412874

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2025-10-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Screening tool group

Screening tool

Intervention Type: OTHER

Participants will complete a screening tool survey

Focus group

No interventions assigned to this group

Interventions

Screening tool

Participants will complete a screening tool survey

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Nihal E Mohamed

Nihal Mohamed, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nihal Mohamed, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-23-00592

Identifier Type: -

Identifier Source: org_study_id