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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-02187 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19PS-24-3 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source | |
| R01CA263532 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Northeastern University | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. . |
|
| Intervention Phase Arm B (usual care) | Active Comparator | Patients receive access to usual care pre- and post-test provider-based genetic counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive provider-based genetic counseling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who receive genetic testing | The proportion of participants who receive genetic testing will be reported. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcomes | Correlations with patient level factors, such as education, literacy, acculturation, and language will be examined. | Up to 3 months |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charite Ricker, MS | Contact | 323-409-7710 | ricker@usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Charite Ricker, MS | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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| Educational Intervention | Other | Receive genetics education |
|
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| Electronic Health Record Review | Other | Ancillary studies |
|
| Genetic Counseling | Other | Receive provider-based genetic counseling |
|
| Interview | Other | Ancillary studies |
|
| Survey Administration | Other | Ancillary studies |
|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| D011471 | Prostatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D005817 | Genetic Counseling |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D033142 | Genetic Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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