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Chatbot Monitoring for Lung Cancer Medication Adherence (iSMART Trial)

N/A

Waitlist Available

Led By Samuel U Takvorian, MD, MSHP

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patient (age > 18 years) with NSCLC at UPHS who is receiving one of the following nine oral therapies: afatinib, erlotinib, dacomitinib, gefitinib, osimertinib, alectinib, brigatinib, crizotinib, or lorlatinib.

Be older than 18 years old

Must not have

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

Taking more than one oral targeted therapy or concurrent chemotherapy during the study window

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after study initiation or at therapy discontinuation, whichever is shorter

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new conversational agent to help manage side effects and improve adherence to oral targeted therapies for lung cancer patients.

Who is the study for?

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.

What is being tested?

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'.

What are the potential side effects?

Since this trial focuses on adherence strategies rather than new medications, there aren't direct side effects from interventions being tested. However, managing existing side effects of the listed oral therapies effectively is part of what's being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 with NSCLC and am taking a specific oral cancer medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am not taking more than one oral cancer drug or chemotherapy at the same time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after study initiation or at therapy discontinuation, whichever is shorter

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after study initiation or at therapy discontinuation, whichever is shorter

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after study initiation or at therapy discontinuation, whichever is shorter for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence

Secondary study objectives

Persistence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 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 ArmActive Control1 Intervention

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

0 / 3Eligibility criteria met