MARVIN Chatbots for Breast Cancer

Recruiting at 3 trial locations

Overseen By Bertrand Lebouché, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Cognitive deficit, others

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

Compensation: Varies

Number of Visits: 1

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different chatbots, including MARVINA, specifically designed for breast cancer patients. The goal is to adapt these chatbots for various health conditions and groups, such as pharmacists and people with HIV. Participants will use the chatbot and provide feedback to help improve it. Ideal candidates are individuals with breast cancer who are comfortable using Facebook Messenger and have reliable internet access.

As an unphased trial, this study allows participants to contribute to innovative technology that could enhance support for various health conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe?

Research has shown that specific safety information for MARVIN or its versions, such as MARVINA, is not available in humans. This trial examines how people use and adapt to MARVIN, rather than conducting traditional safety testing. As a chatbot, MARVIN communicates with users through text or speech. Unlike medicines or medical devices, chatbots do not cause physical side effects. Instead, safety concerns focus on protecting users' privacy and handling data properly. The goal is to ensure the chatbot is easy and safe to use without causing confusion or stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MARVIN Chatbots for Breast Cancer because they explore a new frontier in patient support and education through AI-driven technology. Unlike traditional treatments for breast cancer, which primarily focus on medical interventions like surgery, chemotherapy, and radiation, these chatbots aim to enhance patient care by providing tailored information and emotional support. The MARVINA chatbot, specifically designed for breast cancer patients, offers a unique approach by co-constructing personalized interactions, assessing usability, and continuously improving based on user feedback. This could revolutionize how patients manage their treatment journey, making the process more engaging and supportive.

What evidence suggests that this trial's chatbots could be effective for breast cancer and other health domains?

Research has shown that AI chatbots, such as MARVINA, can assist breast cancer patients. Studies have found that these chatbots enhance patients' understanding of breast cancer, aiding them in learning more about their condition. For instance, one study found that users of an AI chatbot gained significant knowledge about breast cancer throughout their experience. Another study demonstrated that these chatbots also help patients feel more in control and informed about their treatment options. This evidence suggests that MARVINA could be a valuable tool for those dealing with breast cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Bertrand Lebouché, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English or French, can consent to participate, and have access to a device with internet. They must be willing to use Facebook Messenger-based chatbots and accept Facebook's privacy policies.

Inclusion Criteria

Accepting Facebook's privacy and data security policies

I am willing to use or create a Facebook account.

Accepting to use a Facebook Messenger-based Chatbot

Exclusion Criteria

Any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a chatbot (e.g., cognitive deficit)

Not meeting the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Co-construction and Usability Study

Development or adaptation of MARVIN chatbots for different healthcare contexts and evaluation of global usability with a small sample of participants

1 month

1 visit (virtual)

Implementation and Evaluation

Evaluation of implementation and user outcomes with a larger sample, including documentation of factors affecting chatbot utilization

12 months

Quarterly assessments (virtual)

Follow-up

Participants are monitored for continued use and effectiveness of the chatbots

3 months

What Are the Treatments Tested in This Trial?

Interventions

• MARVIN
• MARVINA
• MARVIN-Pharma

Trial Overview

The study tests different MARVIN chatbots (MARVIN, MARVIN-Pharma, MARVINA, MARVIN-CHAMP) designed for various health conditions like breast cancer and HIV. It uses an adaptive platform trial design allowing changes based on early results.

How Is the Trial Designed?

Group I: MARVINA: a Chatbot for Breast Cancer Patients Experimental Treatment 1 Intervention

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Group II: MARVIN: a Chatbot for HIV patients Experimental Treatment 1 Intervention

Co-construction of the chatbot, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Group III: MARVIN: a Chatbot for Community Pharmacists Experimental Treatment 1 Intervention

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Group IV: MARVIN CHAMP: a Chatbot for Pediatric Infectious Conditions Experimental Treatment 1 Intervention

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Published Research Related to This Trial

A study involving 215 neoplasm patients over two years showed that a pharmacists-managed outpatient clinic effectively identified and resolved drug-related problems (DRPs), with 82.6% of issues confirmed as resolved after pharmacist interventions.

Pharmacists played a crucial role in improving patient care, as 90.3% of their planned interventions were accepted by patients or physicians, highlighting their importance in managing medication therapy for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of Pharmacists-Managed Oncology Outpatient Clinic on Resolving Drug-Related Problems in Ambulatory Neoplasm Patients: A Prospective Study in China. Zhao, X., Xu, R., Wang, Y., et al.[2021]

Between 1999 and 2003, a study at Toulouse University Hospital reported 613 adverse drug reactions (ADRs) from antiretroviral drugs affecting 428 patients, highlighting the importance of monitoring these effects.

Most reported ADRs (88.6%) were classified as 'non-serious', but 57% of cases required stopping the suspected medication, indicating that while many reactions were mild, a significant portion still necessitated intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Bandrant, M., Bagheri, H., Cuzin, L., et al.[2016]

A study involving 143 patients receiving immune checkpoint inhibitors showed that intensive pharmacist follow-up and education led to 1664 interventions, significantly improving patient management of immune-related adverse events.

Patients in the pharmacist-supported cohort had lower odds of treatment discontinuation due to immune-related adverse events compared to a control group, with an odds ratio of 5.5, indicating that pharmacist involvement can enhance treatment adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and clinical impact of a pharmacist-led, interdisciplinary service focusing on education, monitoring and toxicity management of immune checkpoint inhibitors. Myers, G., Stevens, J., Flewelling, A., et al.[2022]

This study aims to improve care for patients with chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) by coordinating care between oncology and primary care pharmacists, focusing on patients taking oral anti-cancer agents (OAAs) and managing multiple chronic conditions.

The Pharmacists Coordinated Care Oncology Model (PCOM) will assess the effectiveness of this coordinated approach over two months, measuring medication adherence and patient-reported outcomes, with the goal of enhancing treatment management and overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a model integrating primary and oncology pharmacists' care for patients taking oral anticancer agents (OAA). Farris, KB., Cadwallader, T., Farley, J., et al.[2022]

Chatbots are AI-driven tools that can enhance communication between healthcare providers and patients, facilitating follow-up, screening, and treatment adherence.

Their potential applications in oncology are particularly promising, as they can improve patient engagement and data collection, which may lead to better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare ex Machina: Are conversational agents ready for prime time in oncology? Bibault, JE., Chaix, B., Nectoux, P., et al.[2020]

Highly active antiretroviral therapy (HAART) has significantly improved life expectancy for HIV-infected individuals, making it comparable to the general population, but these patients still face increased cardiovascular risks and certain cancers even with undetectable viral loads.

Clinicians need to be aware of potential drug interactions between antiretrovirals and other medications, as these can lead to serious health risks; combinations of two nucleos(t)ide reverse transcriptase inhibitors with raltegravir or dolutegravir are noted to have fewer clinically significant interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Severe or life-threatening interactions between antiretrovirals and non-HIV drugs]. Manzardo, C., Tuset, M., Miró, JM., et al.[2022]

In a study assessing the quality of responses from AI chatbots ChatGPT and Bing regarding cancer-related questions, ChatGPT scored an average of 3.9 while Bing scored 3.2, indicating that ChatGPT provided higher quality information overall (P < 0.001).

Despite the potential of AI chatbots in healthcare, the study revealed that 3% of ChatGPT's responses and 15% of Bing's responses had serious shortcomings, highlighting the need for ongoing improvements to ensure accurate and supportive information for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician Assessment of ChatGPT and Bing Answers to American Cancer Society's Questions to Ask About Your Cancer. Janopaul-Naylor, JR., Koo, A., Qian, DC., et al.[2023]

In a study of 898 ambulatory cancer patients on oral anticancer treatments, 46% experienced potential drug-drug interactions (PDDIs), with 16% having major interactions that could significantly impact their treatment.

The most common major PDDIs involved coumarins and opioids, often leading to serious effects like central nervous system issues, gastrointestinal toxicity, and prolonged QT intervals, highlighting the need for increased awareness among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of potential drug-drug interactions in cancer patients treated with oral anticancer drugs. van Leeuwen, RW., Brundel, DH., Neef, C., et al.[2022]

The article highlights significant drug interactions among 20 FDA-approved antiretroviral agents, emphasizing the importance of understanding how these interactions can affect the efficacy and toxicity of treatments for HIV.

Healthcare professionals are strongly encouraged to collaborate with infectious disease clinical pharmacists to effectively manage these interactions and optimize patient care in those receiving antiretroviral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Interactions Among the Antiretrovirals. McNicholl, IR.[2020]

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