Implementation Strategies for Monitoring Adherence in Real Time

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation Strategies for Monitoring Adherence in Real Time

Conditions
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Lung Cancer, Medication Adherence, Symptoms and Signs

Intervention / Treatment
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* Device: Conversational Agent/Chatbot
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with lung cancer receiving oral targeted therapies at recruitment sites will be randomized (1:1 stratified by drug class and prescription status) to receive intervention or usual care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 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.<br>|
| Active Comparator: Control Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Defined as the number of adherent days divided by number of prescribed days. Adherent days will be calculated dichotomously based on whether a patient took all prescribed doses for the day within 2 hours of recommended time. 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 | Defined as the number of consecutive days on the regimen and conversely gaps in overall treatment, measured using MEMS caps. | 12 weeks after study initiation or at therapy discontinuation, whichever is shorter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication adherence, symptom management, non-small cell lung cancer, implementation science, digital health, behavioral science