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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

A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer

INTRODUCTION

  • Org Study ID: I-3368823
  • Secondary ID: N/A
  • NCT ID: NCT06414317
  • Sponsor: Roswell Park Cancer Institute

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.

  • Overall Status
    Recruiting
  • Start Date
    January 12, 2024
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

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

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Dharmesh Gopalakrishnan

Role: Principal Investigator

Affiliation: Roswell Park Cancer Institute

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States 		Status: Recruiting Contact: Contact
Dharmesh Gopalakrishnan
716-845-5967
Dharmesh.Gopalakrishnan@RoswellPark.org

Principal Investigator
Dharmesh Gopalakrishnan

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