## Protocol Section
### Identification Module
**NCT ID:** NCT06414317

**Brief 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

**Official Title:** A Comprehensive Education and Navigational Support Program for Advanced Bladder Cancer

#### Organization Study ID Info
**ID:** I-3368823
#### Organization
**Class:** OTHER
**Full Name:** Roswell Park Cancer Institute
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03446
**Type:** REGISTRY
**Domain:** Roswell Park Cancer Institute
**ID:** I-3368823
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Roswell Park Cancer Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Locally Advanced Bladder Carcinoma

- Metastatic Bladder Carcinoma

- Stage III Bladder Cancer AJCC v8

- Stage IV Bladder Cancer AJCC v8

- Unresectable Bladder Carcinoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Assessment of Distress

- Other: Consultation Visit

- Other: Nutritional Assessment

- Other: Questionnaire Administration

- Other: Supportive Care

**Label:** Supportive Care (ENST)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Supportive Care (ENST)

**Description:** Undergo psychological distress screening

**Name:** Assessment of Distress

**Other Names:**

- Assessment of Psychological Distress

- Evaluation of Patient's Distress

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Supportive Care (ENST)

**Description:** Attend consultations

**Name:** Consultation Visit

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Supportive Care (ENST)

**Description:** Undergo malnutrition screening

**Name:** Nutritional Assessment

**Other Names:**

- Dietary Assessment

- dietary counseling

- nutritional counseling

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Supportive Care (ENST)

**Description:** Ancillary studies

**Name:** Questionnaire Administration

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Supportive Care (ENST)

**Description:** Receive access to bladder cancer ENST

**Name:** Supportive Care

**Other Names:**

- Supportive Therapy

- Symptom Management

- Therapy, Supportive

**Type:** OTHER

#### Intervention 6

**Arm Group Labels:**

- Supportive Care (ENST)

**Description:** Attend virtual support group meetings

**Name:** Supportive Care

**Other Names:**

- Supportive Therapy

- Symptom Management

- Therapy, Supportive

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Organizational readiness for implementing change (ORIC)

**Time Frame:** At baseline and at 6 months post-implementation

**Description:** Guideline-concordant care at the institutional level will be calculated as the percentage of all systemic treatment decisions captured in the Clinical Oncology Pathway.

**Measure:** Guideline-concordant care at the institutional level

**Time Frame:** At baseline and at 6 months intervals for the study duration

**Description:** Patient perception of care coordination will be measured using Care Coordination Instrument.

**Measure:** Patient perception of care coordination

**Time Frame:** At baseline and at 3 and 6 months post-implementation

**Description:** 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).

**Measure:** Patient perception of self-efficacy

**Time Frame:** At baseline and at 3 and 6 months post-implementation

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

**Measure:** Caregiver perception of care coordination

**Time Frame:** At baseline and at 3 and 6 months post-implementation

### Eligibility Module

**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)

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Buffalo

**Contacts:**

***Contact 1:***

- **Email:** Dharmesh.Gopalakrishnan@RoswellPark.org

- **Name:** Dharmesh Gopalakrishnan

- **Phone:** 716-845-5967

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dharmesh Gopalakrishnan

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Roswell Park Cancer Institute

**State:** New York

**Status:** RECRUITING

**Zip:** 14263

#### Overall Officials

**Official 1:**

**Affiliation:** Roswell Park Cancer Institute

**Name:** Dharmesh Gopalakrishnan

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5030

- Name: Urinary Bladder Neoplasms

- Relevance: HIGH

- As Found: Bladder Cancer

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000001749

- Term: Urinary Bladder Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
