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.
PRIMARY OBJECTIVES: I. Perform user-testing of an education and patient history collection mobile tool among medical oncologists, radiation oncologists, and urologists across study practice settings, including Veterans Affairs to address genetic referral needs (n=10 providers). (Provider-focused) II. 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: AIM I: Providers attend an interview over 1 hour to discuss how they would use the tool, then receive the tool to test in their clinic for 2 weeks. After 2 weeks, providers 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. AIM II: Patients are randomized to 1 of 2 arms. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
346
Attend Interview
Use web-based genetic education tool online
Ancillary Studies
Receive in-person, telehealth, or over-the-phone genetic counseling
Undergo genetic testing
Ancillary Studies
Receive in-person, telehealth, or over-the-phone genetic counseling
Use web-based genetic education tool online
Undergo genetic testing
Ancillary Studies
VA New York Harbor Health System- Manhattan Campus
New York, New York, United States
New York University- Langone Health
New York, New York, United States
Associated Medical Professions of New York
Syracuse, New York, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Washington/ SCCA
Seattle, Washington, United States
User Testing of the Provider Tool - (Aim I)
Provider perspectives will include: (1) 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), and (2) interaction with this tool affects the user's cognitive representation of genetic testing for prostate cancer (PCA). To evaluate the first point, 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 participants' mental model for germline testing and how they identify suitable candidates before interaction with the tool. Will use a cognitive concept mapping technique, which can be used to formalize a person's cognitive representation for complex topics. Feedback from this testing will be used to iteratively refine the tool while it is being used by providers to identify patients randomized trial in Aim II.
Time frame: Up to 6 months
Decisional Conflict (Aim II)
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
Time frame: Up to 6 months
Cancer Genetics Knowledge (Aim II)
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).
Time frame: Up to 6 Months
Genetic Testing Uptake (Aim II)
Assessed using pre-and post-intervention surveys
Time frame: Up to 5 years
Satisfaction with Genetic Counseling or Web-Based Genetic Education (Aim II)
Will capture men's satisfaction with each arm using the Satisfaction with Genetic Counseling Scale at the end of 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 webtool addressed all of the concerns I had" or "The webtool was valuable to me".
Time frame: After viewing the web tool
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