RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer

Quick Facts

Study Start:2024-01-12
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06414317

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PATIENTS: Age ≥ 18 years
  2. * PATIENTS: Metastatic or locally advanced, unresectable bladder cancer
  3. * PATIENTS: Receiving or planning to receive systemic therapy for bladder cancer at Roswell Park Comprehensive Cancer Center (RPCCC)
  4. * 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
  5. * PATIENTS: Able to speak, understand, read, and write English
  6. * CAREGIVERS: Age ≥ 18 years
  7. * CAREGIVERS: Only caregivers of enrolled patients will be included in the study
  8. * CAREGIVERS: Should be able to speak, understand, read, and write English
  9. * 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)
  1. * 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
  2. * PATIENTS: Predominantly small cell histology
  3. * PATIENTS: Adults with impaired decision-making capacity, assessed by the study team to be unable to participate in ENST-based education and surveys
  4. * PATIENTS: Pregnant women
  5. * CAREGIVERS: Cognitively impaired adults/adults with impaired decision-making capacity
  6. * CAREGIVERS: Individuals who are not yet adults (infants, children, teenagers)

Contacts and Locations

Principal Investigator

Dharmesh Gopalakrishnan
PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Dharmesh Gopalakrishnan, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-12
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2024-01-12
Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

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