Chatbot Monitoring for Lung Cancer Medication Adherence

(iSMART Trial)

Overseen By Jocelyn V Wainwright, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Oral targeted therapies

Must not be taking: Chemotherapy

Disqualifiers: Concurrent trial, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a chatbot (a conversational agent) can assist lung cancer patients in adhering to their medication plans and managing side effects. Participants will either interact with the chatbot on their phones or receive standard care from their doctors. The researchers aim to determine if the chatbot simplifies medication adherence for patients. This trial may suit lung cancer patients who use specific oral therapies and have a mobile phone for text communication. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance medication adherence and side effect management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on more than one oral targeted therapy or concurrent chemotherapy during the study.

What prior data suggests that this conversational agent is safe for patients with lung cancer?

Research has shown that chatbots used in cancer care are generally safe for patients. These digital tools assist patients in managing their conditions. A review found that most safety issues stemmed from incorrect chemotherapy schedules or doses, not from the chatbot itself. Thus, the chatbot did not directly cause harm.

In a study on chatbots in healthcare, participants had mixed feelings. Some found chatbots helpful, while others did not. Importantly, chatbots are not known to cause direct harm. They primarily offer reminders and information, aiding people in better managing their treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a chatbot to monitor lung cancer medication adherence because it introduces a novel approach to patient care. Unlike traditional methods that rely on clinician-driven education and self-monitoring, this conversational agent offers real-time interaction and personalized support via mobile phones. The chatbot can engage patients in daily conversations, reminding them to take their medication and helping them manage symptoms, which could lead to improved adherence and better health outcomes. This innovative use of technology has the potential to transform how patients manage their treatment, making it more interactive and accessible.

What evidence suggests that this chatbot is effective for improving medication adherence in lung cancer patients?

Research has shown that chatbots can assist patients in managing their treatment. In one study, 88% of patients reported that the chatbot was helpful and made it easier to follow their treatment plans. Another study found chatbots useful for managing symptoms and aiding cancer patients in adhering to their treatments. In this trial, participants in the intervention arm will engage with a conversational agent (chatbot) to assist with side effects and medication routines in lung cancer treatments. Meanwhile, the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms. Overall, these findings suggest that chatbots could be a useful tool for patients taking oral targeted therapies for lung cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Katharine A Rendle, PhD,MSW,MPH

Principal Investigator

University of Pennsylvania

Samuel U Takvorian, MD, MSHP

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-small cell lung cancer (NSCLC) at UPHS who are taking specific oral therapies and own a mobile device that can text. They must be able to interact in English and have their oncologist's approval to participate, but cannot be in another therapeutic clinical trial or taking multiple oral therapies.

Inclusion Criteria

Approval from the patient's medical oncologist to be approached

Ability to provide informed consent to participate in the study

Ability to respond to questions and engage with "Penny" in English

Exclusion Criteria

I cannot communicate or understand English well enough to use 'Penny'.

You cannot use text messaging on your phone.

Concurrent enrollment in a therapeutic clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with a conversational agent to improve adherence to oral targeted therapies for lung cancer

12 weeks

Engagement via mobile telephone

Follow-up

Participants are monitored for adherence and persistence using MEMS caps and surveys

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conversational Agent/Chatbot
• Usual Care

Trial Overview The study compares usual care against the use of a conversational agent/chatbot named 'Penny' designed to help patients manage side effects and stick to their medication schedule. It's a two-arm randomized controlled trial where participants will either continue with their regular care or engage with 'Penny'.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Participants in the intervention arm will be tracked and able to engage with the intervention (conversational agent) on their mobile telephone for 12 weeks.

Group II: Control Arm Active Control 1 Intervention

Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Lung Cancer Research Foundation

Collaborator

Trials

4

Recruited

1,200+

Published Research Related to This Trial

The study aims to test 'ChatV', an AI health bot designed to improve adherence to varenicline, a medication for smoking cessation, by providing reminders and support to users during a 12-week treatment period with 40 participants.

The feasibility study will assess how well participants use ChatV and its impact on medication adherence and smoking cessation, with results guiding the decision to proceed to a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study. Minian, N., Mehra, K., Earle, M., et al.[2023]

A pilot study involving 44 postmenopausal women with hormone receptor-positive breast cancer showed that using a web-based app with weekly reminders significantly improved adherence to aromatase inhibitors (AIs) at 8 weeks (100% vs. 72% adherence).

The App+Reminder group also had a higher usage rate of the app (74% vs. 38%), suggesting that reminders can help patients manage their treatment better, potentially leading to better long-term outcomes in cancer survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a web-based app to improve breast cancer symptom management and adherence for aromatase inhibitors: a randomized controlled feasibility trial. Graetz, I., McKillop, CN., Stepanski, E., et al.[2020]

In a study analyzing 25,256 posts about aromatase inhibitors (AIs) on message boards, 18.2% mentioned side effects, with joint pain being the most frequently reported, indicating a significant concern among breast cancer patients.

Among patients discussing their experiences, 12.8% reported discontinuing AIs due to severe joint pain, while 28.1% switched medications, highlighting the need for healthcare providers to address these side effects to improve treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online discussion of drug side effects and discontinuation among breast cancer survivors. Mao, JJ., Chung, A., Benton, A., et al.[2021]

In a study of 3382 women with hormone receptor-positive breast cancer, those with low personal or clinical social support were more likely to not start or adhere to adjuvant endocrine therapy (AET), highlighting the importance of social support in treatment compliance.

Women with moderate or low personal social support had a significantly higher risk of discontinuing AET or being non-adherent, suggesting that healthcare teams should address these support gaps to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal and clinical social support and adherence to adjuvant endocrine therapy among hormone receptor-positive breast cancer patients in an integrated health care system. Kroenke, CH., Hershman, DL., Gomez, SL., et al.[2019]

A randomized controlled trial involving 300 women with early-stage, hormone receptor-positive breast cancer is testing a web-enabled app designed to improve adherence to adjuvant endocrine therapy (AET) by managing symptoms and providing feedback.

The study aims to assess the app's impact on medication adherence, symptom burden, and quality of life over six months, with a focus on addressing racial disparities in breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. Paladino, AJ., Anderson, JN., Krukowski, RA., et al.[2022]

A survey of 17 young adult cancer patients revealed that while most understood their treatment, 24% did not receive guidance on what to do if they missed a dose, indicating a gap in medication education.

Common barriers to adherence included side effects (59%), forgetfulness (47%), and depressive symptoms (35%), highlighting the need for improved support systems and education involving family and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the need for improved strategies and medication-related education to increase adherence for oral anticancer medications in the young adult oncology population. Divakaruni, A., Saylor, E., Duffy, AP.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1556086424016368

P4.15E.02 Acceptability and Feasibility of Integrating A ... This mixed-methods study shares patient and clinician perspectives on the use of a chatbot (“Penny”) to support symptom management and oral anticancer agent ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10162388/

The Use of Chatbots in Oncological Care: A Narrative Review 88.00% of patients reported chatbot provided them with support and helped them follow their treatment effectively. Breast, Cancer treatment, ...

3. pc3i.upenn.edu pc3i.upenn.edu/our-work/projects/ismart/

iSMART: Implementation Strategies for Monitoring Adherence ... iSMART tested the effects of implementing a conversational chatbot to improve oral lung cancer treatment adherence & side-effect symptom management.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11355580/

Chatbots in Cancer Applications, Advantages and ... This state-of-the-art review article seeks to present both the benefits and the drawbacks of chatbots in the context of medicine and cancer.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.28_suppl.424

An augmented intelligence mobile phone chatbot for ... Pilot Study of a Mobile Phone Chatbot for Medication Adherence and Toxicity Management Among Patients With GI Cancers on Capecitabine.

6. cancer.jmir.org cancer.jmir.org/2021/4/e27850/

Chatbot for Health Care and Oncology Applications Using ... This review article aims to report on the recent advances and current trends in chatbot technology in medicine.

7. medrxiv.org medrxiv.org/content/10.1101/2024.09.01.24312881v1.full-text

The Use of Conversational Agents in Self-Management This study provides insights into user interactions with a healthcare CA, highlighting a preference for general health management and diverse usage patterns.