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

Stage IV Bladder Cancer AJCC v8 Clinical Trial

Official title:

A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414317
• Other study ID #: I-3368823
• Secondary ID: NCI-2024-03446I-
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Bladder Carcinoma
• Stage III Bladder Cancer AJCC v8
• Stage IV Bladder Cancer AJCC v8
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Assessment of Distress
Undergo psychological distress screening

Other:
• Consultation Visit
Attend consultations
• Nutritional Assessment
Undergo malnutrition screening
• Questionnaire Administration
Ancillary studies
• Supportive Care
Receive access to bladder cancer ENST
• Supportive Care
Attend virtual support group meetings

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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