Choices About Genetic Testing And Learning Your Risk With Smart Technology

Not Applicable

Active, not recruiting

• Conditions: Ovarian Cancer; Endometrial Cancer; Prostate Cancer; Fallopian Tube Cancer; Colorectal Cancer; Peritoneal Cancer; Breast Cancer; Pancreas Cancer
• Interventions: Diagnostic Test: Relational Agent; Other: Clinical Letter

• Registration Number: NCT06184867
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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 31 individuals (16 EUC, 15 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 Timeline

• Study Start: 2023-09-26
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-09-11
• Study Completion: 2025-09-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relational Agent (RA)	Relational Agent	RA participants will be provided with access to Alex, the RA. After completing the RA, RA participants can proceed directly to GT.
Enhanced Usual Care (EUC)	Clinical Letter	EUC participants will be sent a clinical letter informing them of their increased risk of hereditary cancer, availability of GC and GT services, and contact information to schedule an appointment with a genetic counselor at the LIFE Center.

Primary Outcome Measures

Name	Time	Method
Genetic Testing (GT) Uptake	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability of the Relational Agent (RA)	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.
Genetic Testing (GT) Intentions	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.
Informed Decision-Making Indicators	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).
Genetic Counseling (GC) Uptake	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.

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 New Brunswick, New Jersey, United States