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.
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: 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
Single group
Assessment of Distress
Procedure/SurgeryUndergo psychological distress screening
Consultation Visit
Other interventionAttend consultations
Nutritional Assessment
Other interventionUndergo malnutrition screening
Questionnaire Administration
Other interventionAncillary studies
Supportive Care
Other interventionReceive access to bladder cancer ENST
Supportive Care
Other interventionAttend virtual support group meetings
Organizational readiness for implementing change (ORIC)
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
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
Patient perception of care coordination will be measured using Care Coordination Instrument.
Patient perception of self-efficacy
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).
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