Actively Recruiting
A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-01-29
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial focuses on patients with locally advanced, metastatic, or unresectable bladder cancer and their caregivers. It evaluates an education and navigation support tool (ENST) designed to improve patient and caregiver participation in care coordination and treatment decisions. The study addresses challenges faced by older patients with complex medical needs and limited healthcare access. The research includes assessing organizational readiness, implementing the ENST, and measuring its impact on care coordination and adherence to treatment guidelines. Participants receive access to the bladder cancer ENST and undergo psychological distress and nutritional screenings. They may attend consultations with social work, psychology, and nutrition specialists as needed. Patients, caregivers, and healthcare providers also join virtual support group meetings periodically throughout the study. The study's design emphasizes supportive care through education and navigation to enhance treatment planning and coordination. During the study, researchers will assess care coordination and self-efficacy for both patients and caregivers using validated questionnaires at baseline, 3 months, and 6 months post-implementation. They will also monitor organizational readiness and guideline-concordant care over time. Participants will be involved in screenings, consultations, virtual meetings, and completing questionnaires. The study aims to quantify the impact of the ENST on care coordination and decision-making over several months.
CONDITIONS
Brief Title
An Education and Navigation Support Tool to Improve Participation in Care Coordination Among Patients With Locally Advanced, Metastatic and Unresectable Bladder Cancer and Their Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosis of metastatic, locally advanced, or unresectable bladder cancer
- Receiving or planning to receive systemic therapy for bladder cancer at Roswell Park Comprehensive Cancer Center
- Enrollment possible from initial diagnosis up to 8 weeks after starting first-line systemic therapy
- Able to speak, understand, read, and write English
- Caregivers aged 18 years or older of enrolled patients
- Caregivers able to speak, understand, read, and write English
- Caregivers enrolled within the same time window as patients (from initial visit to within 8 weeks of patients starting frontline therapy)
You will not qualify if you...
- Patients not receiving systemic therapy due to poor performance status, co-morbidities, or inadequate organ function
- Patients with predominantly small cell histology
- Adults unable to participate in education and surveys due to impaired decision-making capacity
- Pregnant women
- Caregivers with cognitive impairment or impaired decision-making capacity
- Caregivers who are not adults (infants, children, teenagers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months post-implementation
Participants receive access to the bladder cancer education and navigation support tool (ENST), and may attend virtual support group meetings periodically during the study.
Periodic virtual support group meetings
Duration - Up to 6 months post-implementation
Participants undergo psychological distress and nutrition screenings and may attend social work, psychology, and nutrition consultations as appropriate throughout the study.
Assessments and consultations as needed throughout the study
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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