Clinical trial · Interventional
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
A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Bladder Carcinoma | Bladder Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Bladder Carcinoma | Bladder Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Bladder Cancer AJCC v8 | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Bladder Cancer AJCC v8 | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Unresectable Bladder Carcinoma | Bladder Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Distress | Procedure | — | UNRESOLVED |
| Consultation Visit | Other | — | UNRESOLVED |
| Nutritional Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Supportive Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (ENST)
- description
- Patients and caregivers receive access to the bladder cancer ENST and patients undergo psychological distress and nutrition screenings and may attend social work, psychology, and/or nutrition consultations as appropriate throughout the study. Patients, caregivers, and providers also attend virtual support group meetings periodically on study.
- interventionNames
- Procedure: Assessment of Distress
- Other: Consultation Visit
- Other: Nutritional Assessment
- Other: Questionnaire Administration
- Other: Supportive Care
Primary outcomes (5)
- measure
- Organizational readiness for implementing change (ORIC)
- timeFrame
- At baseline and at 6 months post-implementation
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available