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OpenTrials
Active, Not Recruiting

NCT Number: NCT04347161

Implementation Strategies for Monitoring Adherence in Real Time

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Health Behavior Lung Diseases Lung Neoplasms Medication Adherence Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Symptoms and Signs Thoracic Neoplasms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conversational Agent/Chatbot

Device

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.

Usual Care

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Lung Cancer Research Foundation
  • Pfizer

Registry information

Acronym: iSMART

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Apr 15, 2020
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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