Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy
NCT ID: NCT07073807
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2025-08-26
2026-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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SMART Intervention Arm
Participants receive the SMART intervention, a multi-level mobile health program using TAPPT® smart labels and a web-based app for real-time OAT adherence tracking. SMART includes personalized text reminders, biweekly symptom and adherence surveys, management of missed or extra doses through oncology alerts, management of symptoms through oncology alerts or educational resources, monthly screening and support for financial and health-related social needs, and tailored educational messages for participants with low health literacy. All participants receive usual oncology care in addition to the SMART intervention.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Must be 18 years of age or older
* Have a diagnosis of any type and stage of cancer
* Have a new prescription for an oral anticancer therapy (OAT) initiated within the last 90 days or planned to start within the next 15 days
* Be receiving treatment at UCI Chao Family Comprehensive Cancer Center-affiliated oncology clinics
* Own a smartphone and be willing to receive study-related text messages.
Exclusion Criteria
* Be medically or cognitively unable to give consent or participate in the study
* Be participating in another clinical trial that monitors adherence or symptoms related to the newly prescribed OAT
18 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Responsible Party
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Gelareh Sadigh
Associate Professor of Radiology
Locations
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Chao Family Comprehensive Cancer Center and Ambulatory Care building
Irvine, California, United States
UCI Health Cancer Center - Newport
Newport Beach, California, United States
UCI Health Pacific Breast Care Center
Newport Beach, California, United States
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, United States
UCI Health - Yorba Linda
Yorba Linda, California, United States
Countries
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Central Contacts
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Aarushi Madan, BS
Role: CONTACT
Facility Contacts
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Other Identifiers
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UCI-25-83
Identifier Type: OTHER
Identifier Source: secondary_id
7375
Identifier Type: -
Identifier Source: org_study_id
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