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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Awards & highlights
iSMART Trial 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.Check my eligibility
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'.See study design
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.
iSMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 with NSCLC and am taking a specific oral cancer medication.
iSMART Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence
Secondary outcome measures
Persistence
iSMART 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.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,013 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,799 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,620 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot communicate or understand English well enough to use 'Penny'.You cannot use text messaging on your phone.I am not taking more than one oral cancer drug or chemotherapy at the same time.I am over 18 with NSCLC and am taking a specific oral cancer medication.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this clinical trial?
"Clinicaltrials.gov does not list this particular trial as actively recruiting at the moment, despite its initial posting date of February 22nd 2021 and most recent edit on October 12th 2022. Nevertheless, there are 1724 other medical trials globally currently in need of patient participation."
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