NCT07073807

Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy

Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy: A Pilot Feasibility Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

New oral anticancer treatments have improved survival across cancer types but introduced challenges in medication adherence and symptom management. The SMART pilot trial will test a new mobile health intervention that facilitates remote adherence and symptom monitoring, patient-provider communication outside of clinic visits regarding the use of oral anticancer treatments, and support for financial and social needs, as well as health literacy support, for 30 English- and Spanish-speaking patients. This study will increase understanding of barriers and facilitators to the use of the proposed mHealth intervention.

Detailed description

New oral anticancer treatments (OATs) have improved survival across cancer types but introduced challenges in medication adherence and symptom management. While OATs offer convenience and at-home treatment, they involve complex dosing, drug interactions, and adverse effects requiring careful self-management, and their high out-of-pocket costs can cause financial hardship, hence resulting in suboptimal adherence. Interventions to improve OAT adherence have had mixed results. Given the widespread use of mobile technology, mobile health (mHealth) options offer scalable solutions for medication management. It is hypothesized that an mHealth intervention offering real-time adherence tracking for any prescribed OAT, monitoring for symptoms, financial and health-related social needs (HRSNs), and providing tailored reminders, education, missed dose and symptom management, and support for financial and social needs and health literacy could improve adherence across different cancers. This study is a 3-month single-arm trial to evaluate the feasibility and acceptability of a multi-level mHealth intervention, Supporting Medication Adherence and Resource Training (SMART), in 30 English- or Spanish-speaking patients with cancer (stratified by age \< 65 and \>65) with a recent prescription for OAT at Chao Family Comprehensive Cancer Center (CFCCC). All patients will use Technology-Assisted Patient-Provider Tool (TAPPT)®, a web-based app that uses smart labels with near-field communication (NFC) technology and smartphone taps to facilitate real-time adherence monitoring. This technology is adaptable to various medication package formats, compatible with both Android and iOS, and capable of monitoring multiple OATs simultaneously. The SMART intervention includes real-time adherence monitoring, missed dose reminder and management, extra or off-cycle dose management, symptom monitoring and management, and includes financial and social needs and low health literacy support. The study examines the feasibility and acceptability of SMART to monitor OAT adherence (Aim 1), explores the preliminary effects of SMART for patient-reported adherence, mHealth monitored adherence, patient-reported quality of life, symptom burden, and healthcare utilization at 3 months (Aim 2), and describes patients' \& providers' experience with the intervention using a mixed-methods approach. Significantly, this study will increase understanding of barriers and facilitators for using SMART intervention for a variety of OATs among English- and Spanish-speaking patients and provide preliminary data to refine our proposed intervention for a future larger randomized controlled trial.

Conditions

• Cancer
• Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring	The SMART intervention uses TAPPT® smart labels and a web-based app for real-time monitoring of oral anticancer therapy adherence. It includes personalized text reminders, biweekly surveys for medication adherence and symptom burden, missed and extra dose management, symptom alerts to providers, monthly financial and health-related social needs screening with tailored resources, and educational texts for low health literacy. TAPPT® smart labels work with Android/iOS smartphones. All participants receive usual oncology care.

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-07-18
• Last updated: 2026-01-22

Locations

5 sites across 1 country: United States