Implementation Strategies for Monitoring Adherence in Real Time

Not Applicable

Active, not recruiting

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control Arm	Usual Care	Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.
Intervention Arm	Conversational Agent/Chatbot	Participants in the intervention arm will be tracked and able to engage with the intervention (conversational agent) on their mobile telephone for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Adherence	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 Outcome Measures

Name	Time	Method
Persistence	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