Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study
Study Details
Study Description
Brief Summary
This trial performs user testing of a mobile-friendly patient history collection and genetic education tool to improve healthcare providers' understanding of prostate cancer genetic testing. This trial also compares traditional genetic counseling versus a web-based genetic education (WBGE) tool to provide information about genetic testing to men with prostate cancer. The WBGE tool has educational modules on genetic counseling and testing, as well as a patient history collection tool to help providers learn which patients may carry genetic mutations and may be considered for genetic counseling and genetic testing. The purpose of this research is to use technology to deliver information on genetic testing for prostate cancer to patients to help them decide whether or not to receive genetic testing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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Perform user-testing of an education and patient history collection mobile tool among medical oncologist, radiation oncologist, and urologists across study practice settings, including Veterans Affairs to address genetic referrals needs (n=10 providers). (Provider-focused)
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Develop multimedia web-based pretest genetic education (WBGE) tool and conduct a randomized trial of traditional genetic counseling (GC) (Arm 1) versus (vs.) WBGE (Arm 2) for informed and timely uptake of genetic testing for men with lethal/predicted lethal prostate cancer (PCA). (Patient-focused)
OUTLINE:
ARM I (TRADITIONAL GENETIC COUNSELING): Patients receive genetic counseling with a certified genetic counselor in-person, by telehealth, or over the phone (according to patient preference). Patients may then undergo genetic testing.
ARM II (WEB-BASED GENETIC EDUCATION): Patients receive a link to the web-based genetic education tool online including all elements of genetic counseling in written modules and in a series of professional videos. Patients may then undergo genetic testing. Patients may cross-over to Arm I to see a genetic counselor.
After the completion of study, patients are followed up yearly for up to 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aim I (Interview) Providers attend an interview over 1 hour to discuss how they would use the tool, then receive the tool to test in their clinical for 2 weeks. After 2 weeks, provides discuss their experience using the tool over 10-15 minutes. Providers have the option to use the tool for up to 6 months and complete a brief survey about the benefits and limitations of the tool for patient identification in Arm II. |
Other: Interview
Attend Interview
Other: Internet Based Intervention
Use web-based genetic education tool online
Other: Survey Administration
Ancillary Studies
|
| Active Comparator: Aim II: Arm I (Genetic Counseling, Genetic Testing) Patients receive genetic counseling with a certified genetic counselor in-person, by telehealth, or over the phone (according to patient preference). Patients may then undergo genetic testing. |
Other: Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling
Genetic: Genetic Testing
Undergo genetic testing
Other Names:
Other: Survey Administration
Ancillary Studies
|
| Experimental: Aim II: Arm II (WBGE, Genetic Couseling, Genetic Testing) Patients receive a link to the web-based genetic education tool online including all elements of genetic counseling in written modules and in a series of professional videos. Patient may then undergo genetic testing. Patient may cross-over to Arm I to see a genetic counselor. |
Other: Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling
Other: Internet-Based Intervention
Use web-based genetic education tool online
Genetic: Genetic Testing
Undergo genetic testing
Other Names:
Other: Survey Administration
Ancillary Studies
|
Outcome Measures
Primary Outcome Measures
- User Testing of the Provider Tool - Questionnaire (Aim I) [Up to 6 months]
Whether the target population can use the tool in the way it was intended (i.e. to perform patient history collection to determine consideration for germline testing). To evaluate, we will collect initial information from participants regarding their experience with the guidelines for genetic testing and how they collect data on family history. Will evaluate the participants' mental model for germline testing and how they identify suitable candidates before and after interaction with the tool.
- User Testing of the Provider Tool - Questionnaire (Aim I) [Up to 6 months]
How interaction with the tool affects the user's cognitive representation of genetic testing for prostate cancer (PCA). Will use a cognitive concept mapping technique, which can be used to formalize a person's cognitive representation for complex topics
- Decisional Conflict (Aim II) [Up to 6 months]
Will be assessed for non-inferiority between study arms. Evaluated using the O'Connor decisional conflict scale, which captures sub-scores over 16-questions for uncertainty, feeling of being informed, values clarity, support, and effective decision making on a 5-point Likert scale
Secondary Outcome Measures
- Cancer Genetics Knowledge (Aim II) [Up to 6 Months]
Assessed using pre-and post-intervention surveys. Cancer genetics knowledge will be adapted from Erblich. et al (2005) for relevance to PCA genetics (23 True/False questions) (Cronbach's alpha = 0.92)
- Genetic Testing Uptake (Aim II) [Up to 5 years]
Assessed using pre-and post-intervention surveys
- Satisfaction with Genetic Counseling or Web-Based Genetic Education (Aim II) [The survey is given one day following pre-test genetic counseling or viewing the webtool.]
Will capture men's satisfaction with each arm using the Satisfaction with Genetic Counseling Scale at the end of the pre-test genetic counseling or after viewing the web tool. This 6-item scale includes questions such as "My genetic counselor seemed to understand the stresses I was facing," and "The genetic counseling session was valuable to me" rated on a 5-point Likert Scale (Cronbach's alpha 0.7-0.88). The questions will be adapted for web-based pretest genetic education such as "This web tool addressed all of the concerns I had" or "The web tool was valuable to me".
Other Outcome Measures
- Understanding of Personal Genetic Test Results (Aim II) [Up to 5 years]
Assessed using pre-and post-intervention surveys
- Sharing of Genetic Information with Families (Aim II) [Up to 5 years]
Assessed using pre-and post-intervention surveys
- Literacy (Aim II) [Up to 5 years]
Assessed using pre-and post-intervention surveys
- Numeracy (Aim II) [Up to 5 years]
Assessed using pre-and post-intervention surveys
- Diet (Aim II) [Up to 5 years]
Assessed using pre-and post-intervention surveys
- Physical Activity (Aim II) [Up to 5 years]
Assessed using pre-and post-intervention surveys
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aim 1: Medical Oncologists, Radiation Oncologists and Urologist spanning Veterans Affairs (VA), academic, and community settings.
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Aim 2: Any English speaking man with PCA who has computer and web-access and meets any of the following:
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Metastatic disease
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T3a or higher
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Prostate specific antigen (PSA) > 20
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Grade group 4 or higher
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Very low to intermediate National Comprehensive Cancer Network (NCCN) risk groups with intraductal pathology or family history of early PCA-related death or cancers suggestive of hereditary breast and ovarian cancer or Lynch Syndrome
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Gleason >= 7 and Ashkenazi Jewish ancestry
Exclusion Criteria:
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Mental or cognitive impairment that interferes with ability to provide informed consent
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Non-English speaking
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Having a prior germline genetic testing for inherited cancer risk (pertains to aim 2)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Thomas Jefferson University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Veda Giri, MD, Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20G.013
- 2020-02556