Access to Genetic Testing in Underserved Patients With Cancer

NCT06422455 | Recruiting DMC

• 4 other identifiers: 19PS-24-3NCI-2024-02187P30CA014089R01CA263532
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who receive genetic testing

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

  Up to 3 months

Secondary Outcomes (1)

• Patient-reported outcomes

  Up to 3 months

Study Arms (2)

Intervention Phase Arm A (PERLA)

EXPERIMENTAL

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

Other: Educational Intervention; Other: Electronic Health Record Review; Other: Genetic Counseling; Other: Interview; Other: Survey Administration

Intervention Phase Arm B (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Best Practice OTHER

Receive provider-based genetic counseling

Also known as: standard of care, standard therapy

Intervention Phase Arm B (usual care)

Educational Intervention OTHER

Receive genetics education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Intervention Phase Arm A (PERLA)

Electronic Health Record Review OTHER

Ancillary studies

Intervention Phase Arm A (PERLA); Intervention Phase Arm B (usual care)

Interview OTHER

Ancillary studies

Intervention Phase Arm A (PERLA)

Genetic Counseling OTHER

Receive provider-based genetic counseling

Intervention Phase Arm A (PERLA)

Survey Administration OTHER

Ancillary studies

Intervention Phase Arm A (PERLA); Intervention Phase Arm B (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who cannot provide informed consent
• Patients who cannot see, read, or write
• Patients with none of the listed cancer diagnoses and clinical characteristics
• Healthcare provider who do not treats cancer patients

Sponsors & Collaborators

• University of Southern California: lead
• Northeastern University: collaborator
• National Cancer Institute (NCI): collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male; Prostatic Neoplasms; Ovarian Neoplasms; Triple Negative Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Genetic Counseling; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Genetic Services; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Charite Ricker, MS

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charite Ricker, MS

CONTACT

323-409-7710; ricker@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: October 24, 2023
• Primary Completion (Estimated): October 24, 2027
• Study Completion (Estimated): October 24, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (2)