Genetic Testing Education for Cancer Survivors

(CATALYST Trial)

Overseen By Emily K Heidt, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Previous germline GT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a digital tool can assist cancer survivors in understanding and using genetic testing for hereditary cancer risks. Participants will engage with different methods of learning about genetic testing, either through a new online program called the Relational Agent (also known as the CATALYST digital intervention) or standard information, to determine which is more helpful. This approach seeks to simplify access to essential genetic information for cancer survivors. Individuals with ovarian, breast, pancreatic, or other listed cancer types and internet access may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve genetic testing access for cancer survivors.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on genetic education and testing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on genetic testing education rather than medication changes.

What prior data suggests that the CATALYST digital intervention is safe for cancer survivors?

Research has shown that relational agents, like the one used in this study, are generally safe for healthcare use. These digital tools, often resembling chatbots, help patients better understand their health. No harmful effects have been associated with these tools.

For example, a study on a similar AI-powered relational agent found that it helped about one-third of eligible patients learn about genetic cancer risks. Although the study primarily assessed the tool's effectiveness rather than its safety, no negative effects were reported. In another study, patients used a similar digital tool to learn about genetic testing, and again, no harm was reported.

This research stage focuses more on usability and user experience rather than safety. However, previous studies have indicated that using this kind of digital assistant is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to educate cancer survivors about genetic testing. The unique feature here is the use of a "Relational Agent" (RA), an interactive digital tool that provides educational content similar to traditional genetic counseling but in a streamlined, digital format. Unlike standard methods that might involve in-person sessions, the RA includes videos, decision support, and real-time Q&A, making the information more accessible and engaging. This approach could make genetic counseling more convenient and prompt better-informed decisions regarding genetic testing.

What evidence suggests that this trial's interventions could be effective for enhancing genetic education and increasing genetic testing uptake among cancer survivors?

Research shows that tools like chatbots can engage patients in genetic testing and counseling for cancer. In this trial, participants in the Relational Agent (RA) arm will receive educational content through a digital tool that provides information and support similar to traditional genetic counseling, streamlining the process for patients to learn about genetic testing. Studies have found that these digital tools assist about one-third of eligible cancer patients in accessing genetic care. Early results suggest these tools are practical and effective in helping patients understand their genetic risks. This improvement could significantly enhance how patients access genetic information and make health decisions. ^{2 3 4 6 7}

Who Is on the Research Team?

Anita Y Kinney, PhD, RN

Principal Investigator

Director at Rutgers Cancer Institute

Are You a Good Fit for This Trial?

This trial is for cancer survivors with specific cancers such as breast, ovarian, prostate, colorectal and pancreatic. Participants should be interested in learning about their genetic risk of cancer through testing and education using smart technology.

Inclusion Criteria

Speak/read and understand English

I have been diagnosed with a specific type of cancer.

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

Exclusion Criteria

I am 18 or older and have not been part of the initial testing phases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

User Testing

Refinement of the digital intervention prototype through usability and user interface testing

4 weeks

Interviews via televideo or face-to-face

Usability Testing

Further refinement of the intervention prototype based on feedback from cancer patients

4 weeks

Interviews via televideo or face-to-face

Pilot Testing

Evaluation of the feasibility and acceptability of the CATALYST intervention in a 2-armed randomized controlled pilot study

6 months

Surveys self-administered via the internet or interviewer administered via telephone

Follow-up

Participants are monitored for genetic testing uptake and other secondary outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Relational Agent

Trial Overview

The study tests a digital tool called CATALYST (a relational assistant) against enhanced usual care to see if it improves genetic education and testing uptake among cancer survivors. Participants will be randomly placed into one of these two groups.

How Is the Trial Designed?

Group I: Relational Agent (RA) Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

A new educational decision aid was developed for women who are carriers of pathogenic BRCA mutations to help them make informed choices about cancer risk management, ensuring it aligns with clinical guidelines and addresses psychosocial issues.

The decision aid was positively received in a pilot test with 23 participants, scoring above 3 on a scale of 1-4 for clarity and usefulness, indicating it effectively supports shared decision-making in cancer risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. Jabaley, T., Underhill-Blazey, ML., Berry, DL.[2021]

A feasibility study involving 60 pancreatic cancer patients showed that an educational chatbot about genetic testing was well-received, with 80% of participants engaging with it and 71% completing surveys.

Patients who opted for genetic testing interacted more with the chatbot, suggesting that providing education through this method may help reduce decisional conflict and encourage testing adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of the Genetic Information Assistant Chatbot to Provide Genetic Education and Study Genetic Test Adoption Among Pancreatic Cancer Patients at Johns Hopkins Hospital. Soley, N., Klein, A., Taylor, CO., et al.[2023]

A text-based intervention using daily reminders and interactive surveys significantly improved medication adherence among post-menopausal breast cancer survivors, with 69.2% of participants completing the study requirements.

The intervention not only enhanced self-reported adherence but also led to measurable decreases in hormone levels, confirming the effectiveness of the treatment, while participants and physicians found the intervention beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. Krok-Schoen, JL., Naughton, MJ., Young, GS., et al.[2022]

The Family Gene Toolkit, a customized web application for families with BRCA1/BRCA2 pathogenic variants, was developed based on feedback from 68 women and is designed to improve family communication about genetic testing results.

In a usability test with 18 women, participants reported high satisfaction with the toolkit, finding it useful for coping strategies and family communication, indicating its potential to promote cascade genetic testing among at-risk relatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Usability of the Family Gene Toolkit for Swiss and Korean Families Harboring BRCA1/BRAC2 Pathogenic Variants: A Web-Based Platform for Cascade Genetic Testing. Baroutsou, V., Duong, V., Signorini, A., et al.[2023]

The Tailored Counseling and Navigation (TCN) intervention significantly increased cancer genetic risk assessment (CGRA) uptake among cancer survivors at elevated risk for hereditary breast and ovarian cancer, with behavioral intention being the strongest mediator of this effect.

The TCN intervention also improved CGRA uptake by enhancing perceived susceptibility, knowledge of hereditary breast and ovarian cancer, and response efficacy, suggesting that effective risk communication is crucial for motivating individuals to seek genetic counseling and testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Mediators of Intervention Effects Within a Randomized Controlled Trial to Motivate Cancer Genetic Risk Assessment Among Breast and Ovarian Cancer Survivors. An, J., Lu, SE., McDougall, J., et al.[2023]

A survey of 276 female breast cancer survivors revealed that only 8% discussed BRCA testing with healthcare providers, indicating a significant gap in communication about genetic testing options.

Only 26% of survivors demonstrated adequate knowledge about BRCA genes, suggesting that increasing education and discussions around genetic testing could empower survivors to make informed decisions regarding their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic testing for breast cancer: where are health care providers in the decision process? Velicer, CM., Taplin, S.[2022]

A new web-based narrative intervention for genetic counseling is being developed to replace traditional methods for women at high risk of breast cancer, focusing on patient preferences and convenience.

The effectiveness of this intervention is being tested in a randomized controlled trial, aiming to improve adherence to guidelines, enhance knowledge about breast cancer risk, and increase satisfaction with the counseling process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a web-based, theory-guided narrative intervention for women at elevated risk for breast cancer. Katz, ML., Senter, L., Reiter, PL., et al.[2023]

Among 1182 breast cancer survivors, Hispanic women had lower rates of genetic testing (61%) compared to non-Hispanic white women (65%), with common barriers including lack of testing recommendations and cost concerns.

Only 27% of tested and 15% of untested women were aware of the Genetic Information Nondiscrimination Act (GINA), indicating a significant need for education about genetic testing and GINA to improve testing rates and address barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic Testing Across Young Hispanic and Non-Hispanic White Breast Cancer Survivors: Facilitators, Barriers, and Awareness of the Genetic Information Nondiscrimination Act. Cragun, D., Weidner, A., Kechik, J., et al.[2022]

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