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

NCT ID: NCT06414317

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-12
• Study Completion Date: 2027-03-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (ENST)

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.

Group Type: EXPERIMENTAL

Assessment of Distress

Intervention Type: PROCEDURE

Undergo psychological distress screening

Consultation Visit

Intervention Type: OTHER

Attend consultations

Nutritional Assessment

Intervention Type: OTHER

Undergo malnutrition screening

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Supportive Care

Intervention Type: OTHER

Receive access to bladder cancer ENST

Supportive Care

Intervention Type: OTHER

Attend virtual support group meetings

Interventions

Assessment of Distress

Undergo psychological distress screening

Intervention Type: PROCEDURE

Consultation Visit

Attend consultations

Intervention Type: OTHER

Nutritional Assessment

Undergo malnutrition screening

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Supportive Care

Receive access to bladder cancer ENST

Intervention Type: OTHER

Supportive Care

Attend virtual support group meetings

Intervention Type: OTHER

Other Intervention Names

Assessment of Psychological Distress; Evaluation of Patient's Distress; Dietary Assessment; dietary counseling; nutritional counseling; Supportive Therapy; Symptom Management; Therapy, Supportive; Supportive Therapy; Symptom Management; Therapy, Supportive

Eligibility Criteria

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 study 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saby George, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Saby George, MD

Role: primary

Saby.George@RoswellPark.org

716-845-3159

Other Identifiers

NCI-2024-03446

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-3368823

Identifier Type: OTHER

Identifier Source: secondary_id

I-3368823

Identifier Type: -

Identifier Source: org_study_id