Lung Cancer Clinical Trial

Implementation Strategies for Monitoring Adherence in Real Time

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.

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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.

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Eligibility Criteria

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 is for people with:

Lung Cancer

Estimated Enrollment:

75

Study ID:

NCT04347161

Recruitment Status:

Active, not recruiting

Sponsor:

Abramson Cancer Center of the University of Pennsylvania

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There is 1 Location for this study

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University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

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Study is for people with:

Lung Cancer

Estimated Enrollment:

75

Study ID:

NCT04347161

Recruitment Status:

Active, not recruiting

Sponsor:


Abramson Cancer Center of the University of Pennsylvania

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