NCT06414317 · Roswell Park Cancer Institute
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
What this study is about
This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for bladder cancer that has spread to nearby tissue or lymph nodes (locally advanced), to other places in the body (metastatic) or that cannot be removed by surgery (unresectable).
View original scientific description
This clinical trial evaluates the impact of an education and navigation support tool (ENST) on patient and caregiver participation in care coordination for bladder cancer that has spread to nearby tissue or lymph nodes (locally advanced), to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Patients with advanced bladder cancer tend to be older, have multiple medical conditions and often have poor access to health care. An ENST may be an effective method to improve participation in treatment decision-making and care planning among patients with locally advanced, metastatic and unresectable bladder cancer and their caregivers.
Interventions
PROCEDURE
Assessment of Distress
Undergo psychological distress screening
OTHER
Consultation Visit
Attend consultations
OTHER
Nutritional Assessment
Undergo malnutrition screening
OTHER
Questionnaire Administration
Ancillary studies
OTHER
Supportive Care
Receive access to bladder cancer ENST
OTHER
Supportive Care
Attend virtual support group meetings
Primary outcome measures
Organizational readiness for implementing change (ORIC)
Time frame: At baseline and at 6 months post-implementation
A 12 item instrument used to determine how well employees feel they can implement the change in process .. Each item includes a scale from 1 (Disagree ) to 5 (Agree)
Guideline-concordant care at the institutional level
Time frame: At baseline and at 6 months intervals for the study duration
Guideline-concordant care at the institutional level will be calculated as the percentage of all systemic treatment decisions captured in the Clinical Oncology Pathway.
Patient perception of care coordination
Time frame: At baseline and at 3 and 6 months post-implementation
Patient perception of care coordination will be measured using Care Coordination Instrument.
Patient perception of self-efficacy
Time frame: At baseline and at 3 and 6 months post-implementation
Patient perception of self-efficacy will be measured using Generalized Self-Efficacy scale. A 10 item psychometric scale with 4 choice responses ranging from 1 (not at all true) to 4 (Exactly true).
Caregiver perception of care coordination
Time frame: At baseline and at 3 and 6 months post-implementation
Caregiver perception of care coordination will be measured using Care Coordination Instrument for Caregivers.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PATIENTS: Age ≥ 18 years
- PATIENTS: Metastatic or locally advanced, unresectable bladder cancer
- PATIENTS: Receiving or planning to receive systemic therapy for bladder cancer at Roswell Park Comprehensive Cancer Center (RPCCC)
- PATIENTS: Subjects can be enrolled any time from initial diagnosis of advanced disease to within 8 weeks after initiation of first-line systemic therapy for advanced bladder cancer
- PATIENTS: Able to speak, understand, read, and write English
- CAREGIVERS: Age ≥ 18 years
- CAREGIVERS: Only caregivers of enrolled patients will be included in the study
- CAREGIVERS: Should be able to speak, understand, read, and write English
- CAREGIVERS: Caregivers will be enrolled in the study during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy)
Exclusion criteria
- PATIENTS: Not receiving any form of systemic therapy for bladder cancer due to Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3, co-morbidities, or inadequate organ function
- PATIENTS: Predominantly small cell histology
- PATIENTS: Adults with impaired decision-making capacity, assessed by the study team to be unable to participate in ENST-based education and surveys
- PATIENTS: Pregnant women
- CAREGIVERS: Cognitively impaired adults/adults with impaired decision-making capacity
- CAREGIVERS: Individuals who are not yet adults (infants, children, teenagers)
Where
- Buffalo, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations