Breast CarcinomaNCT06422455
Access to Genetic Testing in Underserved Patients With Cancer
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Breast Carcinoma and Male Breast Carcinoma, run by University of Southern California at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Male Breast Carcinoma, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Educational Intervention and Electronic Health Record Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2023to 24 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Charite Ricker, 323-409-7710, ricker@usc.edu
Charite Ricker
- Recruiting
University of Rochester
Rochester, New York, 14642
Meghan L. Underhill, meghan_blazey@urmc.rochester.edu
Meghan L. Underhill
About this study
Official title: Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Breast Carcinoma, Male Breast Carcinoma, Malignant Solid Neoplasm, Metastatic Prostate Carcinoma, Ovarian Carcinoma, Pancreatic Exocrine Neoplasm
- Being tested
- Best Practice, Educational Intervention, Electronic Health Record Review, Genetic Counseling, Interview
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male, Prostatic Neoplasms, Ovarian Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive provider-based genetic counseling
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive genetics education
Electronic Health Record ReviewOther
Ancillary studies
Genetic CounselingOther
Receive provider-based genetic counseling
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: 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. Receives: Other: Best Practice; Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who receive genetic testing
The proportion of participants who receive genetic testing will be reported.
Measured: Up to 3 months
Secondary outcomes (1)
Patient-reported outcomes
Correlations with patient level factors, such as education, literacy, acculturation, and language will be examined.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start24 Oct 2023
- Primary completion24 Oct 2027 (estimated)
- Study completion24 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Northeastern University, Dana-Farber Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Charite Ricker, MS, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422455
- Sponsor's protocol ID
- 19PS-24-3
- Other IDs
- NCI-2024-02187, 19PS-24-3, P30CA014089, R01CA263532
- Status last verified
- Mar 2026
- First submitted
- 15 May 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent
- ClinicalTrials.gov ID
- NCT06422455
- Acronym / sponsor ID
- 19PS-24-3
- Conditions
- Breast Carcinoma, Male Breast Carcinoma, Malignant Solid Neoplasm, Metastatic Prostate Carcinoma, Ovarian Carcinoma, Pancreatic Exocrine Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Northeastern University, Dana-Farber Cancer Institute
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 24 Oct 2027 (estimated)
- Study completion
- 24 Oct 2028 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Phase Arm A (PERLA) | Experimental | Other: Educational Intervention, Other: Electronic Health Record Review, Other: Genetic Counseling, Other: Interview, Other: Survey AdministrationPatients receive access to PERLA comprising pre-test genetics education and standard post-test provider-based genetic counseling over 20-60 minutes. . |
| Intervention Phase Arm B (usual care) | Active comparator | Other: Best Practice, Other: Electronic Health Record Review, Other: Survey AdministrationPatients receive access to usual care pre- and post-test provider-based genetic counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18 years old
- Diagnosed with least one of the following:
- Able to read and write in English or Spanish
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive provider-based genetic counseling | Other | Intervention Phase Arm B (usual care) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive genetics education | Other | Intervention Phase Arm A (PERLA) |
| Electronic Health Record ReviewAncillary studies | Other | Intervention Phase Arm A (PERLA), Intervention Phase Arm B (usual care) |
| Genetic CounselingReceive provider-based genetic counseling | Other | Intervention Phase Arm A (PERLA) |
| InterviewAncillary studies | Other | Intervention Phase Arm A (PERLA) |
| Survey AdministrationAncillary studies | Other | Intervention Phase Arm A (PERLA), Intervention Phase Arm B (usual care) |
Primary outcome
Proportion of participants who receive genetic testing
Time frame: Up to 3 months
The proportion of participants who receive genetic testing will be reported.
1 secondary outcome
Patient-reported outcomes
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charite Ricker, MS principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Electronic Health Record Review in people with Breast Carcinoma and Male Breast Carcinoma, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charite Ricker, MS (323-409-7710, ricker@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who receive genetic testing (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.