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

Focus Group Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06412874
• Other study ID #: STUDY-23-00592
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Talia Korn, MA
• Phone: 212-241-4983
• Email: Talia.Korn[@]mountsinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Focus Group
• Urinary Bladder Neoplasms

Intervention

Other:
• Screening tool
Participants will complete a screening tool survey

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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