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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage III Bladder Cancer AJCC v8; Stage IV Bladder Cancer AJCC v8; Metastatic Bladder Carcinoma; Locally Advanced Bladder Carcinoma; Unresectable Bladder Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Nutritional Assessment; Procedure: Assessment of Distress; Other: Consultation Visit; Other: Supportive Care; Other: Supportive Care

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Questionnaire Administration; Ancillary studies; Other: Nutritional Assessment; Undergo malnutrition screening; Other Names: dietary counseling; Dietary Assessment; nutritional counseling; Procedure: Assessment of Distress; Undergo psychological distress screening; Other Names: Assessment of Psychological Distress; Evaluation of Patient's Distress; Other: Consultation Visit; Attend consultations; Other: Supportive Care; Receive access to bladder cancer ENST; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive; Other: Supportive Care; Attend virtual support group meetings; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organizational readiness for implementing change (ORIC)	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)	At baseline and at 6 months post-implementation
Guideline-concordant care at the institutional level	Guideline-concordant care at the institutional level will be calculated as the percentage of all systemic treatment decisions captured in the Clinical Oncology Pathway.	At baseline and at 6 months intervals for the study duration
Patient perception of care coordination	Patient perception of care coordination will be measured using Care Coordination Instrument.	At baseline and at 3 and 6 months post-implementation
Patient perception of self-efficacy	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).	At baseline and at 3 and 6 months post-implementation
Caregiver perception of care coordination	Caregiver perception of care coordination will be measured using Care Coordination Instrument for Caregivers.	At baseline and at 3 and 6 months post-implementation

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Saby George, MD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Patient Care; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Measurements; Palliative Care; Nutrition Assessment
• Other Study ID Numbers: I-3368823 (Other Identifier: Roswell Park Cancer Institute); NCI-2024-03446 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes