Implementation Strategies for Monitoring Adherence in Real Time (iSMART)

February 12, 2026 updated by: Katharine Rendle, Abramson Cancer Center at Penn Medicine
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Drawing from insights in behavioral economics and implementation science, the goal of our project is to identify effective strategies for improving lung cancer outcomes by helping patients to better manage symptoms and adhere to oral therapies. Given the rapid increase in FDA-approved targeted therapies, the need for such strategies will continue to grow. Our central hypothesis is that conversational agent will improve adherence to oral therapies by targeting patient-level determinants of behavior change. The specific aims are to: 1) Test the effects of a patient-directed intervention (conversational agent) to improve adherence to oral targeted therapies in patients with non-small cell lung cancer.; and 2) Use mixed-methods approaches with clinicians and patients to explore multilevel factors shaping the acceptability, effectiveness, and future implementation of intervention into routine cancer care. Primary trial outcomes (adherence and persistence) will be measured using microelectronic monitoring system (MEMS) caps. Secondary outcomes will be assessed using longitudinal surveys and medical record data.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Patient possession of a mobile device that can send/receive SMS texts
  • Ability to respond to questions and engage with "Penny" in English
  • Ability to provide informed consent to participate in the study
  • Approval from the patient's medical oncologist to be approached

Exclusion Criteria:

  • Inability to respond to questions and engage with "Penny" in English
  • Inability or unwillingness to provide informed consent to participate in the study
  • Inability to engage with SMS text-messaging platform
  • Concurrent enrollment in a therapeutic clinical trial
  • Taking more than one oral targeted therapy or concurrent chemotherapy during the study window
  • Lack of approval from the patient's oncologist

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Participants in the intervention arm will be tracked and able to engage with the intervention (conversational agent) on their mobile telephone for 12 weeks.
Device: Conversational Agent/Chatbot
Via text messages, the bidirectional, conversation agent provides specific dosing instructions and motivational reminders to promote oral targeted therapy adherence and symptom management. Patients can report symptoms at any time via text message and are also prompted to report symptoms and medication adherence at periodic intervals. Reported symptoms are monitored and managed algorithmically according severity. High-grade symptoms are triaged directly to the patients' cancer care team. Patients in the intervention arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys.
Active Comparator: Control Arm
Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.
Other: Usual Care
Patients in the control arm will receive usual care, which includes receiving information about dosing and self-administration of oral therapy, and anticipatory guidance for patients regarding management of side effects. Patients in the control arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Defined as number of patients who have 95% or greater adherent days across the study period based on their prescribed dose. Adherence data will be assessed via MEMS caps, which capture a date and time stamp each time the pill bottle is opened.
12 weeks after study initiation or at therapy discontinuation, whichever is shorter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence
Time Frame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Defined as the average number of total days on the regimen before discontinuation measured using MEMS caps across participants
12 weeks after study initiation or at therapy discontinuation, whichever is shorter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Pfizer
Lung Cancer Research Foundation

Investigators

  • Principal Investigator: Samuel U Takvorian, MD, MSHP, University of Pennsylvania
  • Principal Investigator: Katharine A Rendle, PhD,MSW,MPH, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Estimated)

October 16, 2026

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 20520
  • 834713 (Other Identifier: UPenn IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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