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

NCT06414317 | Recruiting

• 2 other identifiers: I-3368823NCI-2024-03446
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Organizational readiness for implementing change (ORIC)

  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

  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

  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

  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

  Caregiver perception of care coordination will be measured using Care Coordination Instrument for Caregivers.

  At baseline and at 3 and 6 months post-implementation

Study Arms (1)

Supportive Care (ENST)

EXPERIMENTAL

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.

Procedure: Assessment of Distress; Other: Consultation Visit; Other: Nutritional Assessment; Other: Questionnaire Administration; Other: Supportive Care

Interventions

Assessment of Distress PROCEDURE

Undergo psychological distress screening

Also known as: Assessment of Psychological Distress, Evaluation of Patient's Distress

Supportive Care (ENST)

Consultation Visit OTHER

Attend consultations

Supportive Care (ENST)

Nutritional Assessment OTHER

Undergo malnutrition screening

Also known as: Dietary Assessment, dietary counseling, nutritional counseling

Supportive Care (ENST)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (ENST)

Supportive Care OTHER

Receive access to bladder cancer ENST

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Supportive Care (ENST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 study during the same time window as for patient enrollment (from initial visit to within 8 weeks of patients starting frontline therapy)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Nutrition Assessment; Palliative Care

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Saby George, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: January 12, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)