Clinical trial NCT06414317: 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
Official title: A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Bladder Carcinoma
Metastatic Bladder Carcinoma
Stage III Bladder Cancer AJCC v8
Stage IV Bladder Cancer AJCC v8
Unresectable Bladder Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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)

Primary outcomes:
measure: Organizational readiness for implementing change (ORIC)
timeFrame: At baseline and at 6 months post-implementation
measure: Guideline-concordant care at the institutional level
timeFrame: At baseline and at 6 months intervals for the study duration
measure: Patient perception of care coordination
timeFrame: At baseline and at 3 and 6 months post-implementation
measure: Patient perception of self-efficacy
timeFrame: At baseline and at 3 and 6 months post-implementation
measure: Caregiver perception of care coordination
timeFrame: At baseline and at 3 and 6 months post-implementation
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Saby George, MD
role: PRINCIPAL_INVESTIGATOR
References: