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

Description

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

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

Study Overview

Study Details

Study overview

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.

A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer

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

Condition
Locally Advanced Bladder Carcinoma
Intervention / Treatment

-

Contacts and Locations

Buffalo

Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 genitourinary (GU) clinic during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy)
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Roswell Park Cancer Institute,

Dharmesh Gopalakrishnan, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

2025-01-01