RecruitingNot ApplicableNCT06414317

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

Sponsor

Roswell Park Cancer Institute

Enrollment

160 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria6

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)