NCT06184867

Choices About Genetic Testing And Learning Your Risk With Smart Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study seeks to enhance genetic education and increase the uptake of genetic testing for hereditary cancer risk among cancer survivors. The study will focus on the feasibility and acceptability of a digital intervention designed to improve cancer genomic care. The study objectives are to: 1. Finalize the development and optimize the usability of the CATALYST digital intervention (also known as the relational assistant \[RA\]). 2. Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model for cancer survivors. Participants will be randomized to one of two study arms: the RA intervention arm or the enhanced usual care (EUC) arm. 3. Assess the uptake of genetic counseling (GC) and genetic testing (GT) and conduct a process evaluation to identify barriers and facilitators to GC, GT, and engagement with the CATALYST intervention and the RA.

Detailed 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 3) of 36 individuals (18 EUC, 18 RA 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 1 and Phase 2. Phase 3 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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Relational Agent (RA)	Consists of a clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among cancer survivors.
BEHAVIORAL	Enhanced Usual Care (EUC)	Consists of a clinical letter and recommendation for genetic testing for hereditary cancer risk among cancer survivors.

Timeline

• Start date: 2023-09-26
• Primary completion: 2025-06-26
• Completion: 2025-06-26
• First posted: 2023-12-28
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States