Digital Delivery Model for Cancer

Recruiting at 33 trial locations

Overseen By Rachel Wills

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Dementia, Cognitive impairment, Psychiatric disorder, others

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

Compensation: Varies

Number of Visits: 6

535 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a digital tool, the Genetic Journey Chatbot, can enhance genetic counseling and testing for young adults with cancer compared to usual telehealth services. Genetic testing helps identify cancer risks and guide treatment, but many young adults do not receive these services. The trial will compare two groups: one using standard remote genetic services and the other using the chatbot for information and support. Patients who have had cancer, are between 18 and 39 years old, can speak English or Spanish, and meet certain genetic testing guidelines are suitable for this trial. As an unphased study, this trial provides a unique opportunity to explore innovative support tools that could enhance genetic counseling experiences.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital delivery model is safe for genetic testing in AYA cancer patients?

Research has shown that chatbots, like the one used in this trial, can safely provide information and support for assessing cancer risk. Some studies examined a chatbot named Rosa, which helps people understand genetic testing for hereditary cancers. These studies indicate that chatbots effectively share information and support, with no reports of serious safety issues.

Digital tools like chatbots have improved access to genetic services. This method aims to make genetic counseling and testing more accessible. Research shows that chatbots help reduce obstacles without adding risks.

In summary, previous research with similar tools considers the chatbot used in this trial safe. No significant negative events have been reported, suggesting it is well-received by users seeking genetic counseling and testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing because it leverages technology to potentially streamline and personalize the genetic testing process. Unlike the standard telehealth visits, this model introduces the Genetic Journey Chatbot, which offers patients a flexible option to receive pre-test education and ongoing support. The chatbot is available 24/7 to answer questions, assess any barriers to testing, and provide timely reminders, which can make the whole experience more accessible and less stressful for patients. This innovative approach could lead to more informed patients and potentially faster decision-making in their care journey.

What evidence suggests that this digital delivery model is effective for increasing genetic counseling and testing uptake in AYA cancer patients?

Research has shown that digital chatbots can be as effective as traditional remote genetic services for cancer patients. In this trial, participants in one arm will receive standard remote genetic services, while those in another arm will access the Genetic Journey Chatbot. Studies have found that chatbots simplify cancer risk assessment and provide genetic counseling. For instance, the Rosa chatbot offers reliable information about hereditary cancers and is well-regarded by both patients and doctors. Chatbots help overcome obstacles to accessing genetic services by making information and support easily available. Early findings suggest they assist patients in understanding genetic testing and taking the next steps, making them a promising tool for enhancing genetic counseling experiences. ^{1 2 3 4 6}

Who Is on the Research Team?

Angela Bradbury, MD

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-39 with any cancer diagnosis, including those in treatment or survivorship. They must speak English or Spanish and be able to understand genetic test results without cognitive impairments or severe psychiatric disorders. Participants should meet guidelines for genetic testing assessment.

Inclusion Criteria

* PATIENTS: Language: In order to complete the mandatory patient-completed measures and receive genetic education and counseling, participants must be able to speak and read English or Spanish

* NON-PATIENT PARTICIPANT: Non-patient participants eligible for this study include: oncology providers, members of the care team and clinic staff, genetic counselors, and insurers (i.e., people who work in financial services and/or for insurance companies) who participate in oncology care among AYA in community for this study

* NON-PATIENT PARTICIPANT: Non-patient participants must be able to speak and read English or Spanish in order to participate in the key informant interview

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either standard remote genetic services or access to the Genetic Journey Chatbot for genetic counseling and testing.

6 months

Telehealth visits as needed

Follow-up

Participants are monitored for outcomes such as knowledge, anxiety, and satisfaction with genetic services.

Up to 42 months

Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing

Trial Overview The study compares a digital chatbot intervention with standard remote genetic services to see if it increases the use of genetic counseling and testing among adolescents and young adult cancer patients. It aims to improve access and efficiency in delivering these services.

How Is the Trial Designed?

Group I: Arm II (Genetic Journey Chatbot) Experimental Treatment 7 Interventions

Patients receive access to the Genetic Journey Chatbot and choose to complete digital pre-test genetic education via the digital tool or via telehealth visit with a genetic counselor. Via the chatbot, patients may request a telehealth visit with a genetic counselor at any time to answer unresolved questions. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results. The chatbot remains available to answer questions, assess barriers, and provide reminders for next steps during the testing period.

Group II: Arm I (standard remote genetic services) Active Control 3 Interventions

Patients attend a standard of care telehealth visit with a genetic counselor for pretest genetic education. Patients then undergo standard of care genetic testing and attend a telehealth visit with a genetic counselor for disclosure of results.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07091617

Testing an Enhanced Digital Delivery Model for Inherited ... The use of a digital chatbot enabled intervention may be equally as effective as standard remote genetic services in AYA cancer patients undergoing genetic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548301/

Patients' and healthcare professionals' experiences with ... Rosa is a chatbot designed to provide reliable information about hereditary breast and ovarian cancer. Built on a commercially available ...

3. ascopubs.org ascopubs.org/doi/10.1200/CCI.23.00123

Chatbot Artificial Intelligence for Genetic Cancer Risk ... Chatbots have been used to streamline genetic cancer risk assessment and counseling and hold promise for reducing barriers to genetic services.

4. sciencedirect.com sciencedirect.com/science/article/pii/S294977442501461X

Utility of eConsult to enhance delivery of cancer genetic ... This study analyzed the utility of electronic consultation (eConsult) for hereditary cancer (HC) and aimed to identify primary care practitioner (PCP) knowledge ...

5. jmir.org jmir.org/2023/1/e46571/

Evaluation of the Rosa Chatbot Providing Genetic ... We developed a chatbot app (Rosa) that is able to perform humanlike digital conversations about genetic BRCA testing.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1532046423002897

Enhanced family history-based algorithms increase the ... Algorithm enhancements increased identification rates for patients eligible for genetic testing of hereditary cancer syndromes, regardless of sex, race, ...