Choices About Genetic Testing And Learning Your Risk With Smart Technology

Study Overview
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Brief Summary
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The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among cancer survivors. The study objectives are to: Finalize the development and optimize usability of the CATALYST digital intervention (i.e., also known as relational assistant (RA)) Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model in cancer survivors. Participants will be randomized to one of two study arms: the RA intervention vs. enhanced usual care (EUC) Assess GC and GT uptake and conduct a process evaluation to measure barriers/facilitators to GC, GT and use of the CATALYST intervention and engagement with the RA.

Detailed Description
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Research Design and Methods: This study encompasses refinement of the digital intervention prototype through usability and user interface testing, and subsequent pilot/feasibility testing of a multi-level intervention, CATALYST, that includes a novel digital cancer genetic risk assistant that incorporates education, decision support, interactive smart technology and provides personalized information regarding hereditary cancer risk and genetic testing. The study will be comprised of three intervention testing stages: Phase 1 - User Testing; Phase 2 - Usability Testing, and Phase 3 - Pilot Testing. User testing and usability testing will be done to refine the intervention prototype by incorporating cancer patients' feedback during each phase. The feasibility and acceptability of the CATALYST intervention will be evaluated in a 2-armed randomized controlled pilot study (Phase III) of 30 individuals (15 in each study arm) identified as high-risk for a hereditary cancer gene mutation according to NCCN Criteria. The primary outcome of interest is GT uptake. Data will be collected via guided interviews (televideo or face-to-face in the clinic or other mutually convenient location (community center) for Phase I and Phase II. Phase III surveys will be self-administered via the internet or interviewer administered via telephone. Interviews and surveys will be comprised of open-ended and close-ended questions.

Official Title
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Choices About Genetic Testing And Learning Your Risk With Smart Technology

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer, Pancreas Cancer, Colorectal Cancer, Endometrial Cancer, Prostate Cancer

Intervention / Treatment
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* Device: Relational Agent
* Other: Clinical Letter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: User/Usability Testing Age 18 or older Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer Speak/read and understand English Capable of providing informed consent Have Internet access (via smartphone, tablet, or computer) Feasibility Randomized Trial Age 18 or older Diagnosed with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, colorectal cancer, breast cancer at age 50 or below or triple negative breast cancer at age 60 or below, pancreatic cancer, or endometrial cancer at age 50 or below, regional/metastatic/intraductal prostate cancer or prostate cancer with a Gleason score ≥7 per NCCN guidelines Speak/read and understand English Capable of providing informed consent Have Internet access (via smartphone, tablet or computer) Have not previously undergone GT for hereditary cancer predisposition Exclusion Criteria: Participants will be 18 years of age or older because germline genetic testing is generally not recommended in children when the test results would not impact clinical management. Participants from the user and usability testing phases are not eligible to participate in the feasibility trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will employ a 2-arm parallel group randomized controlled trial to evaluate the efficacy of the relational agent/chatbot (RA) intervention compared to Enhanced Usual Care (EUC) among 30 cancer survivors.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relational Agent (RA)<br>RA participants will be provided with access to Alex, the RA. After completing the RA, RA participants can proceed directly to GT. | Device: Relational Agent<br>* Alex was developed as an interactive and personalized education and decision support intervention for smart devices, and guides participants through the key primary stages of assessing personal risk of hereditary cancer, providing genetic education, cancer family tree, patient testimonials, asks and answers questions and for those who choose, facilitates genetic testing, and streamlines disclosure of test results.<br>* Other names: Decision support tool;|
| Active Comparator: Enhanced Usual Care (EUC)<br>EUC participants will be sent a clinical letter informing them of their increased risk of hereditary cancer, availability of GC and GT services, and contact information to schedule an appointment with a genetic counselor at the LIFE Center. | Other: Clinical Letter<br>* Letter will be signed by Dr. Toppmeyer and contain a recommendation to contact the Life Center for a cancer genetic risk assessment and to consider GT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic Testing Uptake | Participants receiving Genetic Counseling and or Genetic Testing through the study will be tracked via self-report on surveys and test orders and verified by test results provided by participants. For outside Genetic Counseling and Genetic Testing, we will use self-report, validated by asking for clinic/counselor name and a copy of test report. | 1-month, 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance and Usability of the Relational Agent | Measured through User and Usability testing, a 45-60-minute guided interview hosted virtually by trained Rutgers CINJ study staff and recorded on either Rutgers' HIPAA compliant Microsoft Teams or Zoom where users will interact with the Relational Agent. User testing helps determine if the digital intervention will be used by the intended user and how the user interacts with it. This phase focuses on content related issues and obtains initial feedback on navigating the user interphase and then the Alex RA prototype will be modified accordingly. Usability testing will help ensure that users can effectively use the RA to accomplish tasks, identify technical issues and obtain feedback on site navigation issues, and then the Alex RA prototype will be modified accordingly. Data saturation is reached when no new information on the topic is gained. | Pre-Feasibility Trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hereditary cancer, genetic testing, genetic education, relational agent, chatbot