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

45 Participants Needed

Trial Summary

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 data supports the idea that Genetic Testing Education for Cancer Survivors is an effective treatment?

The available research shows that Genetic Testing Education for Cancer Survivors is effective in helping patients make informed decisions about genetic testing. For example, a study involving pancreatic cancer patients found that about 80% engaged with a chatbot providing genetic education, and 71% completed at least one survey. Participants generally had positive opinions about the education provided and found it helpful in deciding about genetic testing. Those who chose to undergo genetic testing spent more time interacting with the chatbot, indicating that the education helped them feel more confident in their decision. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Relational Agent, CATALYST digital intervention, Relational Assistant (RA) for cancer survivors?

A study on a chatbot providing genetic education to pancreatic cancer patients showed that 80% of participants engaged with it, and those who chose genetic testing spent more time interacting with the chatbot, suggesting that digital interventions can effectively educate and influence decision-making about genetic testing. ^{1 2 3 4 5}

What safety data exists for the genetic testing education treatment?

The provided research does not directly address safety data for the genetic testing education treatment, including the Relational Agent, CATALYST digital intervention, or Relational Assistant. The studies focus on feasibility, acceptability, usability, and effectiveness in increasing genetic testing uptake and decision-making support among cancer survivors. No specific safety concerns or adverse effects are mentioned in the abstracts. ^{1 3 5 6 7}

Is the Genetic Testing Education for Cancer Survivors intervention safe for humans?

The studies reviewed do not provide specific safety data for the Genetic Testing Education intervention, but they do indicate that similar digital tools and interventions, like chatbots and web-based platforms, were well-received and considered helpful by participants, suggesting they are generally safe to use. ^{1 3 5 6 7}

Is the treatment in the trial 'Genetic Testing Education for Cancer Survivors' a promising treatment?

Yes, the treatment is promising because it helps cancer survivors understand genetic testing better, which can lead to more informed decisions about their health. Tools like the Family Gene Toolkit and chatbots have shown high satisfaction and usefulness in helping people communicate genetic information and decide on testing. This suggests that genetic testing education can be a valuable support for cancer survivors. ^{2 3 5 7 8}

How does the genetic testing education treatment for cancer survivors differ from other treatments?

This treatment is unique because it focuses on educating cancer survivors about genetic testing, helping them understand the benefits and implications of genetic information, which can guide their care and decision-making. Unlike traditional treatments that focus on physical interventions, this approach emphasizes education and communication to empower patients and their families. ^{2 3 5 7 8}

What is the purpose of this trial?

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.

Research Team

Anita Y Kinney, PhD, RN

Principal Investigator

Director at Rutgers Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Development of a web-based, theory-guided narrative intervention for women at elevated risk for breast cancer. [2023]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Increasing Adherence to Adjuvant Hormone Therapy Among Patients With Breast Cancer: A Smart Phone App-Based Pilot Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Genetic testing for breast cancer: where are health care providers in the decision process? [2022]

6. United States 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. [2022]

7. Switzerland 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Development and Testing of a Decision Aid for Unaffected Women with a BRCA1 or BRCA2 Mutation. [2021]