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

March 4, 2026 updated by: Anita Y. Kinney, PhD, RN, Rutgers, The State University of New Jersey

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relational Agent (RA)
Participants in the RA arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program with a link to the HIPAA-compliant RA. The RA will provide educational content equivalent to traditional genetic counseling (GC) in a streamlined format, including videos, decision support, patient testimonials, and real-time Q&A. Participants will be informed that they can consult with a genetic risk specialist at no cost. Those opting for genetic testing (GT) will have a kit mailed to them, with results shared with the participant and their oncologist, tailored to the findings. Participants undecided or unwilling to proceed with GT will be encouraged by the RA to consult their oncology provider and/or schedule a GC appointment.
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.
Other Names:
  • Chatbot
  • Decision support tool
  • Alex
  • Digital health tool
Active Comparator: Enhanced Usual Care (EUC)
Participants in the EUC arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program. The letter will inform participants of their and their family's potential risk for carrying a pathogenic variant (PV) associated with hereditary cancer. It will emphasize their eligibility for genetic testing (GT), recommend considering a genetic counseling (GC) appointment for further information, and provide a link to the Rutgers Cancer Institute high-risk clinic website. The study team will assist in facilitating GT upon request. Results will be shared with the participant and their oncologist and tailored according to the findings.
Behavioral: Enhanced Usual Care (EUC)
Consists of a clinical letter and recommendation for genetic testing for hereditary cancer risk among cancer survivors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic Testing (GT) Uptake
Time Frame: 1-month, 6-month follow-up
GT uptake will be defined as the proportion of participants who undergo genetic testing within 6 months of the baseline survey (for both the EUC and RA arms). This will be verified through medical record documentation. Self-reported GT will be tracked if verification is not feasible.
1-month, 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the Relational Agent (RA)
Time Frame: 1-month follow-up

Acceptability will be assessed using the Chatbot Usability Questionnaire (CUQ), which evaluates key aspects of the chatbot, including its personality, onboarding process, user experience, and error handling.

The CUQ consists of 16 items, each rated on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree), with scores ranging from 16 to 80. These scores will be normalized to a scale of 100. A CUQ score of 68 or higher will indicate acceptable usability.
1-month follow-up
Genetic Testing (GT) Intentions
Time Frame: Baseline, 1-month, 6-month follow-up
GT intentions will be assessed using a single-item question based on the Ottawa Decision Support Framework, with six options that assess participants' readiness to engage in decision-making, ranging from not considering the choices to having already made a decision and being unlikely to change. This operationalization captures the concept of reactance to health messaging, an EPPM construct.
Baseline, 1-month, 6-month follow-up
Informed Decision-Making Indicators
Time Frame: Baseline, 1-month, 6-month follow-up

Hereditary Cancer Knowledge will assess understanding of hereditary cancer, inheritance patterns, risk factors, and genetic testing implications using a 10-item Knowledge Index based on ASCO guidelines. Response options include "Agree," "Disagree," or "I don't know."

Decision Conflict will be measured with a 12-item scale on uncertainty, being informed, personal values, and support in decision-making, plus 4 items on decision quality. Items are rated on a 5-point Likert scale (Cronbach's alpha = 0.78).

Decision Regret will be assessed using a 5-item scale on distress/remorse post-decision (Cronbach's alpha = 0.81-0.92).

Decision Satisfaction will use a 6-item scale (Cronbach's alpha = 0.86).

Psychological distress will be assessed using the PROMIS anxiety and depression subscales.

Health Beliefs will assess Perceived Susceptibility, Self-Efficacy for genetic testing, and Response Efficacy using 4 items per subscale (Cronbach's alpha = 0.85-0.93).
Baseline, 1-month, 6-month follow-up
Genetic Counseling (GC) Uptake
Time Frame: 1-month, 6-month follow-up
GC uptake will be defined as the proportion of participants who undergo genetic counseling within 6 months of the baseline survey (for both the EUC and RA arms). This will be verified through medical record documentation. Self-reported GC will be tracked if verification is not feasible.
1-month, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Anita Y Kinney, PhD, RN, Director at Rutgers Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Actual)

June 26, 2025

Study Completion (Actual)

June 26, 2025

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132307
  • Pro2023000964 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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