## Protocol Section
### Identification Module
**NCT ID:** NCT06422455

**Brief Title:** Access to Genetic Testing in Underserved Patients With Cancer

**Official Title:** Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent

#### Organization Study ID Info
**ID:** 19PS-22-3
#### Organization
**Class:** OTHER
**Full Name:** University of Southern California
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-02187
**Type:** REGISTRY
**Domain:** USC / Norris Comprehensive Cancer Center
**ID:** 19PS-22-3
**Type:** OTHER
**ID:** P30CA014089
**Link:** https://reporter.nih.gov/quickSearch/P30CA014089
**Type:** NIH
**ID:** R01CA263532
**Link:** https://reporter.nih.gov/quickSearch/R01CA263532
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Southern California

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive information from a human genetics healthcare provider. Patients with cancer are increasingly recommended for genetic testing as standard of care. Multiple factors contribute to low usage of genetic testing but for many patients the lack of access to genetic counseling and testing is an important and flexible factor. Lack of access is especially relevant to racial/ethnic minority patients and those living in non-metropolitan rural settings who are frequently cared for at safety-net hospitals with limited genetics services. Alternative delivery models are necessary to improve rates of access to genetic testing in patients with cancer. Health information technology is under used by genetics providers. A patient-facing relational agent (PERLA) will provide pre-test genetics education in both English and Spanish across two clinical settings to facilitate more timely access to genetic testing. Using the PERLA intervention may help researchers learn different ways to provide education about genetic testing to patients with cancer compared to usual care.

**Detailed Description:** PRIMARY OBJECTIVES:

I. To obtain patient and provider input on the optimal content and format of a new relational agent (RA) intervention ("PERLA") for automated pre-test genetics education.

II. To obtain patient feedback on the usability of the English- and Spanish-language PERLAs.

III. To determine the acceptability of the newly designed English- and Spanish-language PERLAs among patients with cancer.

IV. To evaluate the impact of the English- and Spanish-language PERLAs on the proportion of patients who meet cancer-based genetic testing guidelines who receive genetic test results within 3 months of initiating cancer care.

V. To evaluate the potential barriers and facilitators to implementation of PERLA in the clinical setting.

OUTLINE:

DEVELOPMENT PHASE: Participants attend focus groups and provide feedback on the content, format, and usability of the PERLAs to enable to tailor the design of the intervention.

USABILITY PHASE: Participants attend usability testing and provide feedback through cognitive interviews.

PILOT TESTING PHASE: Participants evaluate the newly developed PERLAs and provide feedback through focused interviews and structured assessment.

INTERVENTION PHASE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes.

ARM B: Patients receive access to usual care pre- and post-test provider-based genetic counseling.

IMPLEMENTATION PHASE: Participants complete qualitative interviews to evaluate potential barriers and facilitators to implementation of PERLA in the clinic.

After completion of study intervention, patients are followed up at 1, 3, and 6 months.

### Conditions Module

**Conditions:**

- Breast Carcinoma

- Male Breast Carcinoma

- Malignant Solid Neoplasm

- Metastatic Prostate Carcinoma

- Ovarian Carcinoma

- Pancreatic Exocrine Neoplasm

- Stage IVB Prostate Cancer American Joint Committee on Cancer v8

- Triple-Negative Breast Carcinoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 800

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .

**Intervention Names:**

- Other: Educational Intervention

- Other: Electronic Health Record Review

- Other: Genetic Counseling

- Other: Interview

- Other: Survey Administration

**Label:** Intervention Phase Arm A (PERLA)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients receive access to usual care pre- and post-test provider-based genetic counseling.

**Intervention Names:**

- Other: Best Practice

- Other: Electronic Health Record Review

- Other: Survey Administration

**Label:** Intervention Phase Arm B (usual care)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention Phase Arm B (usual care)

**Description:** Receive provider-based genetic counseling

**Name:** Best Practice

**Other Names:**

- standard of care

- standard therapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Intervention Phase Arm A (PERLA)

**Description:** Receive genetics education

**Name:** Educational Intervention

**Other Names:**

- Education for Intervention

- Intervention by Education

- Intervention through Education

- Intervention, Educational

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Intervention Phase Arm A (PERLA)

- Intervention Phase Arm B (usual care)

**Description:** Ancillary studies

**Name:** Electronic Health Record Review

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Intervention Phase Arm A (PERLA)

**Description:** Receive provider-based genetic counseling

**Name:** Genetic Counseling

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Intervention Phase Arm A (PERLA)

**Description:** Ancillary studies

**Name:** Interview

**Type:** OTHER

#### Intervention 6

**Arm Group Labels:**

- Intervention Phase Arm A (PERLA)

- Intervention Phase Arm B (usual care)

**Description:** Ancillary studies

**Name:** Survey Administration

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The proportion of participants who receive genetic testing will be reported.

**Measure:** Proportion of participants who receive genetic testing

**Time Frame:** Up 3 months

#### Secondary Outcomes

**Description:** Correlations with patient level factors, such as education, literacy, acculturation, and language will be examined.

**Measure:** Patient-reported outcomes

**Time Frame:** Up to 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age \> 18 years old
* Diagnosed with least one of the following:

  * Epithelial ovarian cancer
  * Exocrine pancreatic cancer
  * Metastatic or high or very high-risk prostate cancer
  * Breast cancer at or before age 50
  * Bilateral breast cancer
  * Triple negative breast cancer
  * Male breast cancer OR
  * Healthcare provider who treats patients with any of the above types of cancer
* Able to read and write in English or Spanish
* Able to provide informed consent

Exclusion Criteria:

* Patients who cannot provide informed consent
* Patients who cannot see, read, or write
* Patients who have the cancer and clinical characteristics defined in the inclusion criteria, but who do not speak English or Spanish
* Patients with none of the listed cancer diagnoses and clinical characteristics
* Healthcare provider who do not treats cancer patients

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ricker@usc.edu

**Name:** Charite Ricker, MS

**Phone:** 323-409-7710

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** ricker@usc.edu

- **Name:** Charite Ricker

- **Phone:** 323-409-7710

- **Role:** CONTACT

***Contact 2:***

- **Name:** Charite Ricker

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** USC / Norris Comprehensive Cancer Center

**State:** California

**Zip:** 90033

**Location 2:**

**City:** Rochester

**Contacts:**

***Contact 1:***

- **Email:** meghan_blazey@urmc.rochester.edu

- **Name:** Meghan L. Underhill

- **Role:** CONTACT

***Contact 2:***

- **Name:** Meghan L. Underhill

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Rochester

**State:** New York

**Zip:** 14642

#### Overall Officials

**Official 1:**

**Affiliation:** University of Southern California

**Name:** Charite Ricker, MS

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

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

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Carcinoma

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M20665

- Name: Breast Neoplasms, Male

- Relevance: HIGH

- As Found: Male Breast Carcinoma

- 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: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: LOW

- As Found: Unknown

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: LOW

- As Found: Unknown

- ID: T861

- Name: Breast Cancer, Male

- Relevance: HIGH

- As Found: Male Breast Carcinoma

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000009369

- Term: Neoplasms

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000018567

- Term: Breast Neoplasms, Male

### Misc Info Module

- Version Holder: 2024-05-31
