iSMART: Implementation Strategies for Monitoring Adherence in Real Time

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT04347161

Collaborator

Lung Cancer Research Foundation (Other), Pfizer (Industry)

170

Enrollment

Location

Arms

22.2

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Medication Adherence Symptoms and Signs	Device: Conversational Agent/Chatbot Other: Usual Care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

Due to the nature of the intervention, participants and their care providers (including investigators) will not be blinded. The primary analyst and outcomes assessor will be blinded. Blinding may be broken in an emergency.

Primary Purpose:

Supportive Care

Official Title:

Implementation Strategies for Monitoring Adherence in Real Time

Actual Study Start Date :

Feb 22, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Participants in the intervention arm will be tracked and able to engage with the intervention (conversational agent) on their mobile telephone for 12 weeks.	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.
Active Comparator: Control Arm Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.	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.

Arm

Intervention/Treatment

Experimental: Intervention Arm

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

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.

Active Comparator: Control Arm

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

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.

Outcome Measures

Primary Outcome Measures

Adherence [12 weeks after study initiation or at therapy discontinuation, whichever is shorter]
Defined as the number of adherent days divided by number of prescribed days. Adherent days will be calculated dichotomously based on whether a patient took all prescribed doses for the day within 2 hours of recommended time. 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

Persistence [12 weeks after study initiation or at therapy discontinuation, whichever is shorter]
Defined as the number of consecutive days on the regimen and conversely gaps in overall treatment, measured using MEMS caps.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania
Lung Cancer Research Foundation
Pfizer

Investigators

Principal Investigator: Katharine A Rendle, PhD,MSW,MPH, University of Pennsylvania
Principal Investigator: Samuel U Takvorian, MD, MSHP, University of Pennsylvania