## Protocol Section
### Identification Module
**NCT ID:** NCT06412874

**Acronym:** ACCESS

**Brief Title:** Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer

**Official Title:** Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer

#### Organization Study ID Info
**ID:** STUDY-23-00592
#### Organization
**Class:** OTHER
**Full Name:** Icahn School of Medicine at Mount Sinai
### Status Module
#### Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-09
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Pfizer

#### Lead Sponsor

**Class:** OTHER

**Name:** Icahn School of Medicine at Mount Sinai

#### Responsible Party

**Investigator Affiliation:** Icahn School of Medicine at Mount Sinai

**Investigator Full Name:** Nihal E Mohamed

**Investigator Title:** Nihal Mohamed, Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The overall goal of this study is to facilitate care improvements for bladder cancer patients with locally advanced or metastatic disease by designing and evaluating a patient need assessment screening tool to be used, in the future, as standard screening measure. Adult individuals diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer will be included in this study and asked to participate in a focus group, complete a screening tool, or complete a survey. All data collected will be linked to a study ID number and HIPAA identifiers will not be linked to study data. Identifying information (ie: name, mrn, email, phone number) will be utilized for study recruitment and identifying eligible patients. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.

### Conditions Module

**Conditions:**

- Screening Tool

- Focus Group

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 210

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Screening tool

**Label:** Screening tool group

#### Arm Group 2

**Label:** Focus group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Screening tool group

**Description:** Participants will complete a screening tool survey

**Name:** Screening tool

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The Bladder Cancer Need Assessment Survey (BCNAS) includes 8 subscales: psychological, informational, care and support, logistic, sexuality, physical and daily living, communication with providers; and communication with social partners/family

All subscales scored 0-100. Full scale scored from 0- 100. Higher score mean higher levels of unmeet needs.

This is a measure of unmet needs.

**Measure:** The Bladder Cancer Need Assessment Survey (BCNAS)

**Time Frame:** 2023-2025

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients are eligible to participate if they are diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer
* between 18 years and older (18-89 years)
* have initiated any systemic treatment for advanced urothelial carcinoma
* speak English speaking and are able to consent.

Exclusion Criteria:

* Have a diagnosis of another advanced cancer that has required systemic therapy
* Or have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements.

**Maximum Age:** 89 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Bladder cancer survivors

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Talia.Korn@mountsinai.org

**Name:** Talia Korn, MA

**Phone:** 212-241-4983

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** Talia.Korn@mountsinai.org

- **Name:** Talia Korn, MA

- **Phone:** 305-610-5218

- **Role:** CONTACT

***Contact 2:***

- **Name:** Nihal Mohamed, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Icahn School of Medicine at Mount Sinai

**State:** New York

**Status:** RECRUITING

**Zip:** 10029

#### Overall Officials

**Official 1:**

**Affiliation:** Icahn School of Medicine

**Name:** Nihal Mohamed, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- 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: BXS

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

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5030

- Name: Urinary Bladder Neoplasms

- Relevance: HIGH

- As Found: Bladder Cancer

- 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: D000001749

- Term: Urinary Bladder Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
