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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this project is to identify effective strategies to help patients with lung cancer manage side effects and achieve optimal adherence to oral targeted therapies. To achieve this objective, we will evaluate the effect of a novel, bidirectional conversational agent, compared to usual care, on adherence to oral targeted therapies using a two-arm randomized controlled trial, and explore how multilevel factors impact the acceptability and effectiveness of this strategy by collecting qualitative and quantitative data from clinicians and patients.

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 data supports the effectiveness of using a chatbot to monitor medication adherence in lung cancer patients?

Research shows that using technology like interactive voice response systems and web-based apps can improve medication adherence in cancer patients by providing reminders and symptom management support. This suggests that a chatbot could similarly help lung cancer patients stick to their medication schedule. ^{1 2 3 4 5}

Is the chatbot monitoring for medication adherence safe for humans?

The research does not provide specific safety data about chatbot monitoring for medication adherence, but it does mention that adherence to cancer medications is important to minimize treatment toxicity (harmful effects). ^{4 5 6 7 8}

How does the chatbot treatment for lung cancer medication adherence differ from other treatments?

The chatbot treatment is unique because it uses an AI conversational agent to provide medication reminders, answer questions, and track medication intake, which is different from traditional treatments that do not typically include interactive digital support for adherence. ^{2 3 5 9 10}

Research Team

Katharine A Rendle, PhD,MSW,MPH

Principal Investigator

University of Pennsylvania

Samuel U Takvorian, MD, MSHP

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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'.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. Netherlands 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. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder. [2021]

3. United States 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. [2020]

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

Treatment monitoring program for implementation of adherence to second-line erlotinib for advanced non-small-cell lung cancer. [2015]

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

Satisfaction With an Interactive Voice Response System and Symptom Management Toolkit Intervention to Improve Adherence in Patients Prescribed an Oral Anticancer Agent. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Online discussion of drug side effects and discontinuation among breast cancer survivors. [2021]

7. England 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. [2018]

8. England 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. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

AI Conversational Agent to Improve Varenicline Adherence: Protocol for a Mixed Methods Feasibility Study. [2023]

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

A pilot study of an automated voice response system and nursing intervention to monitor adherence to oral chemotherapy agents. [2018]