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Education and Navigation Support for Advanced Bladder Cancer

This study is testing an Education and Navigation Support Tool (ENST) to help patients with locally advanced (spread to nearby tissue), metastatic (spread to other parts of the body), or unresectable (cannot be removed by surgery) bladder cancer, and their caregivers, better participate in their care. The ENST aims to improve how patients and caregivers are involved in treatment decisions and care planning. We want to see if this tool helps patients feel more connected to their care and if the care they receive aligns with recommended guidelines. This study is for adults aged 18 and older who have advanced bladder cancer and are receiving or planning to receive systemic therapy at Roswell Park Comprehensive Cancer Center. The study plans to enroll 160 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 160 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive access to the bladder cancer ENST, undergo psychological distress and nutrition screenings, and may attend consultations. You may also attend virtual support group meetings.
Compensation
Not stated in the trial record.
Follow-up
Your perception of care coordination will be measured at 3 and 6 months after the ENST is implemented. Guideline-concordant care will be measured at 6-month intervals for the study duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06414317

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

Active, Not Recruiting
NAAges 18+InterventionalSupportive care
Roswell Park Cancer Institute
~12 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Assessment of DistressConsultation VisitNutritional AssessmentQuestionnaire AdministrationSupportive Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Organizational readiness for implementing change (ORIC)
Measured over At baseline and at 6 months post-implementation
+4 more outcomes measured

Conditions

Locally Advanced Bladder Carcinoma
Metastatic Bladder Carcinoma
Stage III Bladder Cancer AJCC v8
Stage IV Bladder Cancer AJCC v8
Unresectable Bladder Carcinoma

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NCT06414317

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Roswell Park Cancer Institute

    Buffalo, New Yorkno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Saby George, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Organizational readiness for implementing change (ORIC)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 levelAt 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 coordinationAt 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-efficacyAt 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 coordinationAt baseline and at 3 and 6 months post-implementation

    Caregiver perception of care coordination will be measured using Care Coordination Instrument for Caregivers.