Access to Genetic Testing in Underserved Patients With Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06422455
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Best Practice — OTHER
    Receive provider-based genetic counseling
  • Educational Intervention — OTHER
    Receive genetics education
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Genetic Counseling — OTHER
    Receive provider-based genetic counseling
  • Interview — OTHER
    Ancillary studies
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Oct 24, 2023
Status verified
Mar 2026
Primary completion
Oct 24, 2027
Completion
Oct 24, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention Phase Arm A (PERLA)
    Patients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. .
  • Active Comparator: Intervention Phase Arm B (usual care)
    Patients receive access to usual care pre- and post-test provider-based genetic counseling.

Primary Outcome Measure

Proportion of participants who receive genetic testing [ Time Frame: Up to 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Charite Ricker
[email protected]
323-409-7710
Charite Ricker (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642
Meghan L. Underhill
[email protected]
Meghan L. Underhill (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Breast cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
USC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Rochester· Rochester, NY

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