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

May 13, 2024 updated by: Roswell Park Cancer Institute

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Dharmesh Gopalakrishnan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: At baseline and at 6 months post-implementation
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
Time Frame: At baseline and at 6 months intervals for the study duration
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
Time Frame: At baseline and at 3 and 6 months post-implementation
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
Time Frame: At baseline and at 3 and 6 months post-implementation
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
Time Frame: At baseline and at 3 and 6 months post-implementation
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

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Dharmesh Gopalakrishnan, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

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)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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