Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Carcinoma

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

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.

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.

Interview

Use web-based genetic education tool online

Internet Based Intervention

Survey Administration

Receive in-person, telehealth, or over-the-phone genetic counseling

Genetic Counseling

Genetic Testing

Internet-Based Intervention

Veda Giri, MD

Stacy Loeb, MD, MSc

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.

Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study

Technology-Enhanced Acceleration of Germline Evaluation for Therapy - The TARGET Study

Assessed using pre- and post-intervention surveys.

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.

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

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).

Assessed using pre-and post-intervention surveys

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".

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study	NCT04447703	Biochemically R... Metastatic Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta...	Interview Internet Based ... Survey Administ... Genetic Counsel... Genetic Testing Survey Administ... Genetic Counsel... Internet-Based ... Genetic Testing Survey Administ...	18 Years -	Thomas Jefferson University
Technology-Enhanced Acceleration of Germline Evaluation for Therapy, TARGET Study	NCT04447703	Biochemically R... Metastatic Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta...	Interview Internet Based ... Survey Administ... Genetic Counsel... Genetic Testing Survey Administ... Genetic Counsel... Internet-Based ... Genetic Testing Survey Administ...	18 Years -	Thomas Jefferson University

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