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

Not Applicable

Recruiting

• Conditions: Metastatic Bladder Carcinoma; Unresectable Bladder Carcinoma; Locally Advanced Bladder Carcinoma; Stage IV Bladder Cancer AJCC v8; Stage III Bladder Cancer AJCC v8
• Interventions: Procedure: Assessment of Distress; Other: Consultation Visit; Other: Nutritional Assessment; Other: Questionnaire Administration; Other: Supportive Care

• Registration Number: NCT06414317
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2024-01-12
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion 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)

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (ENST)	Assessment of Distress	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.
Supportive Care (ENST)	Consultation Visit	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.
Supportive Care (ENST)	Supportive Care	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.
Supportive Care (ENST)	Nutritional Assessment	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.
Supportive Care (ENST)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Organizational readiness for implementing change (ORIC)	At baseline and at 6 months post-implementation	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	At baseline and at 6 months intervals for the study duration	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	At baseline and at 3 and 6 months post-implementation	Patient perception of care coordination will be measured using Care Coordination Instrument.
Patient perception of self-efficacy	At baseline and at 3 and 6 months post-implementation	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).
Caregiver perception of care coordination	At baseline and at 3 and 6 months post-implementation	Caregiver perception of care coordination will be measured using Care Coordination Instrument for Caregivers.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States