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Implementation Strategies for Monitoring Adherence in Real Time

NCT04347161 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-03-04

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Lung Cancer Research Foundation

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Katharine A Rendle, PhD,MSW,MPH · University of Pennsylvania

  • Samuel U Takvorian, MD, MSHP · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2022-11-30
Completion
2026-10-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04347161 on ClinicalTrials.gov