Chatbot vs Usual Care for Genetic Testing in Cancer Survivors

(PROPEL Trial)

Recruiting at 1 trial location

Overseen By Julie Chapman Greene, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: No internet, Prior genetic testing, others

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

Compensation: Varies

Number of Visits: 1

428 Participants Needed

Trial Summary

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 education and testing, so it's unlikely that your medications will be affected.

What data supports the effectiveness of the treatment Relational agent (RA) / Chatbot, Relational Agent, Chatbot Intervention for genetic testing in cancer survivors?

Research shows that chatbots can effectively provide genetic education and help patients make informed decisions about genetic testing, as seen in a study with pancreatic cancer patients where 80% engaged with the chatbot and found it helpful. Additionally, chatbots are considered acceptable for moderately complex tasks in genetic service delivery, especially when used alongside usual care. ^{1 2 3 4 5}

Is the chatbot intervention safe for use in genetic testing for cancer survivors?

The research does not report any safety concerns with using chatbots for genetic education and counseling in cancer patients. Participants generally had favorable opinions about the chatbot, and it was considered helpful in making decisions about genetic testing. ^{1 2 3 6 7}

How is the chatbot treatment different from other treatments for genetic testing in cancer survivors?

The chatbot treatment is unique because it uses artificial intelligence to simulate human conversation, providing genetic education and support to cancer survivors. This approach helps patients understand genetic testing and make informed decisions, offering a more interactive and accessible alternative to traditional methods of genetic counseling. ^{1 2 3 7 8}

What is the purpose of this trial?

The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among Black cancer survivors. The study will: 1. Test the effectiveness of a chatbot intervention (also called relational agent, or RA) vs. enhanced usual care (EUC) on engagement in genetic education and requests for genetic testing. 2. Evaluate the impact of the chatbot vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes). 3. Explore the ways (methods) that influence how participants experience the intervention. The main questions this study aims to answer are which group - the chatbot (RA) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education. Participants will be randomly assigned to either the chatbot (RA) group or EUC group. This means each participant has an equal chance of being placed in either group, just like flipping a coin. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the chatbot (RA) group and the EUC group to see which may request more GT (genetic testing) and which group engages more with genetic education.

Research Team

Anita Y Kinney, PhD, RN

Principal Investigator

Director at Rutgers Cancer Institute

Eligibility Criteria

This trial is for Black or African American cancer survivors, aged 18-80, who are at least six months post-diagnosis with specific cancers like breast or prostate. They must have been treated at a participating site within the last two years and meet criteria for genetic testing.

Inclusion Criteria

Identify as Black or African American

Able to read and speak in English

Have received treatment or follow-up oncology care at one of the participating sites in the prior two years

Exclusion Criteria

Unable to access the Internet

I have had genetic testing for cancer risk.

I am unable to understand and give consent for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to either the chatbot (RA) group or EUC group to receive genetic education and have an opportunity to request genetic testing.

6 months

Ongoing virtual interactions

Follow-up

Participants are monitored for informed decision-making and psychosocial outcomes via surveys at 1-month and 6-month intervals.

6 months

Surveys at 1-month and 6-month intervals

Treatment Details

Interventions

• Relational agent (RA) / Chatbot

Trial Overview The study compares a chatbot (RA) that provides genetic education to enhanced usual care (EUC). It aims to see which group is more likely to engage in genetic education and request genetic testing. Participants will be randomly assigned to either group.

Participant Groups

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

Participants in the RA arm will receive a clinical letter from the institution's clinical genetics program with a link to the RA. The fully HIPAA-compliant RA will provide comparable educational information to traditional genetic counseling (GC) but in a streamlined and tailored manner including video, education and decision support, patient testimonial and answers to questions in real-time. Participants will be informed that they may speak to a genetic risk specialist free of charge. For participants who wish to proceed directly to GT, the RA will alert staff to these requests and a GT kit will be mailed to them. Results will be shared with the participant, their oncologist and tailored per the result. Participants who indicate that they are unsure or do not want GT will be encouraged by RA to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic or via a link to the automated scheduling tool in the RA.

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

Participants in the EUC arm will also be mailed a clinical letter signed by the Medical Director of the institution's clinical genetics program. The letter sent to EUC participants will inform them of their own and their family's potential risk for carrying a pathogenic variant (PV) related to hereditary cancer. The letter will emphasize their eligibility for GT, include a recommendation to consider scheduling a GC appointment to obtain more information, and include a link to the CINJ or LCCC high-risk clinic website. The study team will help facilitate GT when requested by the participant. Results will be shared with the participant, their oncologist and tailored per the result.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

In a study involving 95,166 patients, 64.2% engaged with a clinical chatbot designed to assess hereditary cancer risk, with 89.4% completing the risk assessment, indicating high acceptability and usability of the tool.

The chatbot identified that 25% of users met the criteria for genetic testing for hereditary cancer syndromes, and among those tested, 5.6% had a pathogenic variant, demonstrating its effectiveness in triaging high-risk patients for further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. Nazareth, S., Hayward, L., Simmons, E., et al.[2023]

A qualitative study involving 30 participants revealed that while chatbots are seen as useful for moderately complex tasks in the genetic testing process, they are considered inefficient for very simple or very complex tasks.

Participants expressed a preference for chatbots to complement traditional care rather than replace it, emphasizing the need for access to a clinician as a 'safety net' for more complex inquiries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding the sweet spot: a qualitative study exploring patients' acceptability of chatbots in genetic service delivery. Luca, S., Clausen, M., Shaw, A., et al.[2023]

The interactive electronic Cancer Survivorship Patient Engagement Toolkit (CaS-PET) significantly improved health-related quality of life and reduced symptom burden among 30 cancer survivors over a three-month period.

The toolkit effectively supports cancer survivors transitioning from treatment to survivorship by providing personalized care plans and ongoing communication, highlighting its potential as a valuable resource in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Impact of a Cancer Survivorship Patient Engagement Toolkit on Selected Health Outcomes. Nahm, ES., Miller, K., McQuaige, M., et al.[2020]

The CancerHelp-Talking Touchscreen (CancerHelp-TT) program significantly improved cancer knowledge among patients with Stage I-III breast or colorectal cancer, with an effect size of 0.48, indicating its effectiveness in enhancing patient understanding during treatment.

While the intervention showed positive trends in self-efficacy, health beliefs, and satisfaction with communication, the overall effect sizes were small, suggesting that additional support may be necessary for vulnerable patients outside of cancer clinic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Low Literacy, Multimedia Health Information Technology Intervention to Enhance Patient-Centered Cancer Care in Safety Net Settings Increased Cancer Knowledge in a Randomized Controlled Trial. Peipert, JD., Lad, T., Khosla, PG., et al.[2023]

A multimodal intervention is being tested to improve access to cancer genetic counseling and testing, particularly for historically underserved populations, aiming to enhance the identification of patients at risk for familial cancer syndromes.

The study will evaluate the effectiveness of this intervention by comparing diagnostic findings and care utilization between participants receiving the new literacy-focused genetic counseling approach and those receiving usual care, using data from two large healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations. Mittendorf, KF., Kauffman, TL., Amendola, LM., et al.[2022]

Chatbots have been evaluated in seven studies for their effectiveness in genetic cancer risk assessment and counseling, showing a pooled completion rate of 36.7% for risk assessments, indicating they can help streamline the process.

While chatbots show promise in making genetic services more accessible, there is a lack of comprehensive data on user characteristics and their effectiveness compared to traditional care methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chatbot Artificial Intelligence for Genetic Cancer Risk Assessment and Counseling: A Systematic Review and Meta-Analysis. Webster, EM., Ahsan, MD., Perez, L., et al.[2023]

An on-site nurse-led cancer genetics service significantly increased the likelihood of completing germline genetic testing (GT) for cancer among Veterans, showing a 3.2-fold higher completion rate compared to telegenetics services.

This increase in GT completion was particularly notable among self-identified Black Veterans, who had a 4.78 times higher likelihood of completing testing when seen by the on-site service, highlighting the importance of equitable access to genetic testing in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On-Site Nurse-Led Cancer Genetics Program Increases Cancer Genetic Testing Completion in Black Veterans. Shevach, JW., Aiello, LB., Lynch, JA., et al.[2023]

References

1. 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]

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

Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Finding the sweet spot: a qualitative study exploring patients' acceptability of chatbots in genetic service delivery. [2023]

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

Testing the Impact of a Cancer Survivorship Patient Engagement Toolkit on Selected Health Outcomes. [2020]

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

A Low Literacy, Multimedia Health Information Technology Intervention to Enhance Patient-Centered Cancer Care in Safety Net Settings Increased Cancer Knowledge in a Randomized Controlled Trial. [2023]

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

Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations. [2022]

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

Chatbot Artificial Intelligence for Genetic Cancer Risk Assessment and Counseling: A Systematic Review and Meta-Analysis. [2023]

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

On-Site Nurse-Led Cancer Genetics Program Increases Cancer Genetic Testing Completion in Black Veterans. [2023]