Implementation Strategies for Monitoring Adherence in Real Time (iSMART)

Abramson Cancer Center at Penn Medicine

Status: Active, not recruiting

Conditions: Medication Adherence; Symptoms and Signs; Lung Cancer

Treatments: Other: Usual Care; Device: Conversational Agent/Chatbot

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04347161

834713

UPCC 20520

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Participants in the intervention arm will be tracked and able to engage with the intervention (conversational agent) on their mobile telephone for 12 weeks.

Treatment:

Device: Conversational Agent/Chatbot

Control Arm

Active Comparator group

Description:

Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.

Treatment:

Other: Usual Care