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

Metastatic Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04447703
• Other study ID #: 20G.013
• Secondary ID: 19CHAL05
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: September 2029

Study information

• Verified date: January 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 346
• Est. completion date: September 2029
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• AIM 1: Medical oncologists, radiation oncologists and urologists spanning Veterans Affairs (VA), academic, and community settings

• AIM 2: Any English speaking man >= 18 with PCA who has computer and web-access and meets any one of the following:

• Metastatic disease

• T3a or higher

• Prostate specific antigen (PSA) > 20

• Grade group 4 or higher

• Intraductal or cribriform histology

• Biochemical recurrence

• Ashkenazi Jewish ancestry

• Family history criteria (see below) ** Family history: If any one of the following levels are met, the person is eligible:

• Level 1: >= 1 close blood relative (first degree relative [FDR], second degree relative [SDR], third degree relative [TDR]) diagnosed with breast cancer =< age 50 or the following cancers at any age: pancreatic, ovarian, or metastatic or intraductal/cribriform prostate cancer

• Level 2: >= 2 close blood relatives (FDR, SDR, TDR) on same side of the family with breast or prostate cancer at any age

• Level 3: one brother, father, or >= 2 family members (close blood relatives
• FDR, SDR, TDR) on the same side of the family diagnosed with prostate cancer at < 60

• Level 4: >= 3 cancers on the same side of the family (especially if diagnosed =< 50): bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (grade groups 2-5 if known), small bowel, or urothelial

Exclusion Criteria

• Age < 18 years

• Mental or cognitive impairment that interferes with ability to provide informed consent

• Non-English speaking

• Having had prior germline genetic testing for inherited cancer risk (pertains to aim 2)

Related Conditions & MeSH terms

• Biochemically Recurrent Prostate Carcinoma
• Carcinoma
• Metastatic Prostate Carcinoma
• Prostatic Neoplasms
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Intervention

Other:
• Interview
Attend Interview
• Internet Based Intervention
Use web-based genetic education tool online
• Survey Administration
Ancillary Studies
• Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling

Genetic:
• Genetic Testing
Undergo genetic testing

Other:
• Survey Administration
Ancillary Studies
• Genetic Counseling
Receive in-person, telehealth, or over-the-phone genetic counseling
• Internet-Based Intervention
Use web-based genetic education tool online

Genetic:
• Genetic Testing
Undergo genetic testing

Other:
• Survey Administration
Ancillary Studies

Locations

Country	Name	City	State
United States	New York University- Langone Health	New York	New York
United States	VA New York Harbor Health System- Manhattan Campus	New York	New York
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Washington/ SCCA	Seattle	Washington
United States	Associated Medical Professions of New York	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Prostate Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Understanding of personal genetic test results (Aim II)	Assessed using pre- and post-intervention surveys.	Up to 5 years
Other	Sharing of genetic information with families (Aim II)	Assessed using pre- and post-intervention surveys.	Up to 5 years
Other	Literacy (Aim II)	Assessed using pre- and post-intervention surveys.	Up to 5 years
Other	Numeracy (Aim II)	Assessed using pre- and post-intervention surveys.	Up to 5 years
Other	Diet (Aim II)	Assessed using pre- and post-intervention surveys.	Up to 5 years
Other	Physical activity (Aim II)	Assessed using pre- and post-intervention surveys.	Up to 5 years
Primary	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.	Up to 6 months
Primary	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	Up to 6 months
Secondary	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).	Up to 6 Months
Secondary	Genetic Testing Uptake (Aim II)	Assessed using pre-and post-intervention surveys	Up to 5 years
Secondary	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".	After viewing the web tool