428 Participants Needed

Chatbot vs Usual Care for Genetic Testing in Cancer Survivors

(PROPEL Trial)

Recruiting at 1 trial location
ES
AK
JC
Overseen ByJulie Chapman Greene, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12367

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.12378

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

AY

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
See 2 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Relational Agent (RA)Experimental Treatment1 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 Control1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

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]
Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. [2023]
Finding the sweet spot: a qualitative study exploring patients' acceptability of chatbots in genetic service delivery. [2023]
Testing the Impact of a Cancer Survivorship Patient Engagement Toolkit on Selected Health Outcomes. [2020]
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]
Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations. [2022]
Chatbot Artificial Intelligence for Genetic Cancer Risk Assessment and Counseling: A Systematic Review and Meta-Analysis. [2023]
On-Site Nurse-Led Cancer Genetics Program Increases Cancer Genetic Testing Completion in Black Veterans. [2023]
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