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

A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess project readiness and barriers and requirements to assure success we will evaluate organizational readiness and implementation climate through stakeholder engagement. II. Development of an ENST to meet the needs of patients and caregivers, the delivery of which is deemed feasible based on such pre-implementation assessment. III. Implementation and delivery of the proposed ENST. IV. Facilitation of enhanced care coordination for patients with advanced bladder cancer who often have complex medical needs, using measures elaborated in the design and methods section. V. Determining the impact of such interventions, in a quantifiable manner, using validated instruments to assess perceptions of care coordination and self-efficacy, as well as monitoring concordance with guideline-recommended care by leveraging data from a network-wide decision support tool that captures systemic therapy selections. OUTLINE: 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-12
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2024-05-16
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States