Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414317
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-06
Brief Title:
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
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor nutrition consultations as appropriate throughout the study Patients caregivers and providers also attend virtual support group meetings periodically on study
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 andor nutrition consultations as appropriate throughout the study Patients caregivers and providers also attend virtual support group meetings periodically on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03446 | REGISTRY | None | None |
| I-3368823 | OTHER | Roswell Park Cancer Institute | None |