Trial 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
NCT ID:
NCT06414317
Condition:
Locally Advanced Bladder Carcinoma
Metastatic Bladder Carcinoma
Stage III Bladder Cancer AJCC v8
Stage IV Bladder Cancer AJCC v8
Unresectable Bladder Carcinoma
Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Assessment of Distress
Description:
Undergo psychological distress screening
Arm group label:
Supportive Care (ENST)
Other name:
Assessment of Psychological Distress
Other name:
Evaluation of Patient's Distress
Intervention type:
Other
Intervention name:
Consultation Visit
Description:
Attend consultations
Arm group label:
Supportive Care (ENST)
Intervention type:
Other
Intervention name:
Nutritional Assessment
Description:
Undergo malnutrition screening
Arm group label:
Supportive Care (ENST)
Other name:
Dietary Assessment
Other name:
dietary counseling
Other name:
nutritional counseling
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (ENST)
Intervention type:
Other
Intervention name:
Supportive Care
Description:
Receive access to bladder cancer ENST
Arm group label:
Supportive Care (ENST)
Other name:
Supportive Therapy
Other name:
Symptom Management
Other name:
Therapy, Supportive
Intervention type:
Other
Intervention name:
Supportive Care
Description:
Attend virtual support group meetings
Arm group label:
Supportive Care (ENST)
Other name:
Supportive Therapy
Other name:
Symptom Management
Other name:
Therapy, Supportive
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.
Criteria for eligibility:
Criteria:
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:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dharmesh Gopalakrishnan
Phone:
716-845-5967
Email:
Dharmesh.Gopalakrishnan@RoswellPark.org
Investigator:
Last name:
Dharmesh Gopalakrishnan
Email:
Principal Investigator
Start date:
January 12, 2024
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06414317
