Focus Group, Screening Tool
Conditions
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.
Interventions
OTHERScreening tool
Participants will complete a screening tool survey
Sponsors
Icahn School of Medicine at Mount Sinai
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Bladder Cancer Need Assessment Survey (BCNAS) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNihal Mohamed, PhD
Icahn School of Medicine
Outcome results
None listed