Implementation Strategies for Monitoring Adherence in Real Time

Lung Cancer Clinical Trial

— iSMART  

Official title:

Implementation Strategies for Monitoring Adherence in Real Time

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04347161
• Other study ID #: UPCC 20520
• Secondary ID: 834713
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: November 5, 2024

Study information

• Verified date: May 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: November 5, 2024
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Medication Adherence
• Symptoms and Signs

Intervention

Device:
• Conversational Agent/Chatbot
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.

Other:
• Usual Care
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Lung Cancer Research Foundation, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	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.	12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Secondary	Persistence	Defined as the average number of total days on the regimen before discontinuation measured using MEMS caps across participants	12 weeks after study initiation or at therapy discontinuation, whichever is shorter