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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06414317
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Assessment of Distress — PROCEDURE
    Undergo psychological distress screening
  • Consultation Visit — OTHER
    Attend consultations
  • Nutritional Assessment — OTHER
    Undergo malnutrition screening
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Supportive Care — OTHER
    Receive access to bladder cancer ENST
  • Supportive Care — OTHER
    Attend virtual support group meetings

Study Details

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.

Key Dates

Start date
Jan 12, 2024
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Organizational readiness for implementing change (ORIC) [ Time Frame: At baseline and at 6 months post-implementation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Saby George, MD
[email protected]
716-845-3159
Saby George, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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