Implementation Strategies for Monitoring Adherence in Real Time

NCT04347161 | Active Not Recruiting Results FDA Device

• 2 other identifiers: UPCC 20520834713
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Medication Adherence; Symptoms and Signs

Keywords

medication adherence; symptom management; non-small cell lung cancer; implementation science; digital health; behavioral science

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Persistence

  12 weeks after study initiation or at therapy discontinuation, whichever is shorter

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

ACTIVE COMPARATOR

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

Interventions

Conversational Agent/Chatbot DEVICE

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.

Intervention Arm

Usual Care OTHER

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lung Cancer Research Foundation: collaborator
• Pfizer: collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Medication Adherence; Signs and Symptoms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Results Point of Contact

• Title: Katharine A Rendle, PhD,MSW,MPH
• Organization: University of Pennsylvania

Katharine.Rendle@pennmedicine.upenn.edu

215-349-5442

Study Officials

• Katharine A Rendle, PhD,MSW,MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Samuel U Takvorian, MD, MSHP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 15, 2020
• Study Start: February 22, 2021
• Primary Completion: November 30, 2022
• Study Completion (Estimated): October 16, 2026
• Last Updated: March 4, 2026
• Results First Posted: May 3, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)