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

Mount Sinai Health System

Status: Active, not recruiting

Conditions: Focus Group; Screening Tool

Treatments: Other: Screening tool

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06412874

STUDY-23-00592

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

210 participants in 2 patient groups

Screening tool group

Treatment:

Other: Screening tool

Focus group