Choices About Genetic Testing And Learning Your Risk With Smart Technology

Breast Cancer Clinical Trial

— CATALYST  

Official title:

Choices About Genetic Testing And Learning Your Risk With Smart Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184867
• Other study ID #: 132307
• Secondary ID: Pro2023000964
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 26, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Emily K Heidt, BS
• Phone: 732-735-8692
• Email: ekh47[@]cinj.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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: 1. Finalize the development and optimize usability of the CATALYST digital intervention (i.e., also known as relational assistant (RA)) 2. 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) 3. 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 31, 2025
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• User/Usability Testing

1. Age 18 or older

2. Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer

3. Speak/read and understand English

4. Capable of providing informed consent

5. Have Internet access (via smartphone, tablet, or computer)

• Feasibility Randomized Trial

1. Age 18 or older

2. 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

3. Speak/read and understand English

4. Capable of providing informed consent

5. Have Internet access (via smartphone, tablet or computer)

6. 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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Peritoneal Cancer
• Prostate Cancer

Intervention

Diagnostic Test:
• Relational Agent
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.

Other:
• Clinical Letter
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.

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with 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	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