Locally Advanced Bladder CarcinomaNCT06414317
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 study testing Assessment of Distress, Consultation Visit and Nutritional Assessment in people with Locally Advanced Bladder Carcinoma and Metastatic Bladder Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma, Stage III Bladder Cancer AJCC v8
- What is being tested?
- Assessment of Distress, Consultation Visit and Nutritional Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 25 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma, Stage III Bladder Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Unresectable Bladder Carcinoma
- Being tested
- Assessment of Distress, Consultation Visit, Nutritional Assessment, Questionnaire Administration, Supportive Care
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of DistressProcedure or surgery
Also called Assessment of Psychological Distress, Evaluation of Patient's Distress
Undergo psychological distress screening
Consultation VisitOther
Attend consultations
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Undergo malnutrition screening
Questionnaire AdministrationOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive access to bladder cancer ENST
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Attend virtual support group meetings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Assessment of Distress; Other: Consultation Visit; Other: Nutritional Assessment; Other: Questionnaire Administration; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At baseline and at 3 and 6 months post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start12 Jan 2024
- Primary completion25 Sep 2026
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saby George, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414317
- Sponsor's protocol ID
- I-3368823
- Other IDs
- NCI-2024-03446, I-3368823
- Status last verified
- Nov 2026
- First submitted
- 6 May 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer
- ClinicalTrials.gov ID
- NCT06414317
- Acronym / sponsor ID
- I-3368823
- Conditions
- Locally Advanced Bladder Carcinoma, Metastatic Bladder Carcinoma, Stage III Bladder Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Unresectable Bladder Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (ENST) | Experimental | Procedure: Assessment of Distress, Other: Consultation Visit, Other: Nutritional Assessment, Other: Questionnaire Administration, Other: Supportive CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of DistressAlso: Assessment of Psychological Distress, Evaluation of Patient's DistressUndergo psychological distress screening | Procedure or surgery | Supportive Care (ENST) |
| Consultation VisitAttend consultations | Other | Supportive Care (ENST) |
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingUndergo malnutrition screening | Other | Supportive Care (ENST) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (ENST) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive access to bladder cancer ENST | Other | Supportive Care (ENST) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveAttend virtual support group meetings | Other | Supportive Care (ENST) |
Primary outcome
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)
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.
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saby George, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of Distress, Consultation Visit and Nutritional Assessment in people with Locally Advanced Bladder Carcinoma and Metastatic Bladder Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organizational readiness for implementing change (ORIC) (time frame: At baseline and at 6 months post-implementation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.