Clinical trial NCT04347161: Implementation Strategies for Monitoring Adherence in Real Time
Official title: Implementation Strategies for Monitoring Adherence in Real Time
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Medication Adherence
Symptoms and Signs
Keywords: medication adherence
symptom management
non-small cell lung cancer
implementation science
digital health
behavioral science
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Lung Cancer Research Foundation
name: Pfizer
First posted: 2020-04-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adherence
timeFrame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Secondary outcomes:
measure: Persistence
timeFrame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katharine A Rendle, PhD,MSW,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Samuel U Takvorian, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: