Choices About Genetic Testing And Learning Your Risk With Smart Technology — CATALYST  

Breast Cancer Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

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

• NCT number: NCT06184867
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Contact: Emily K Heidt, BS
• Phone: 732-735-8692
• Email: ekh47@cinj.rutgers.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 26, 2023
• Completion date: January 31, 2025