Choices About Genetic Testing And Learning Your Risk With Smart Technology

Last updated: March 4, 2026
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Completed

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Digestive System Neoplasms

Endometriosis

Treatment

Enhanced Usual Care (EUC)

Clinical Letter

Relational Agent (RA)

Clinical Study ID

NCT06184867
132307
Pro2023000964
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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)

Randomized Feasibility Trial

  1. Age 18 or older

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

  3. Meet National Comprehensive Cancer Network (NCCN) criteria for germline GT

  4. Speak/read and understand English

  5. Capable of providing informed consent

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

Exclusion

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 for the feasibility trial. Feasibility trial participants cannot have previously undergone germline GT for hereditary cancer risk.

Study Design

Total Participants: 50
Treatment Group(s): 5
Primary Treatment: Enhanced Usual Care (EUC)
Phase:
Study Start date:
September 26, 2023
Estimated Completion Date:
June 26, 2025

Study 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.

Connect with a study center

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers University

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

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