Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy
SMART pilot
2 other identifiers
interventional
35
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Aug 2025
Shorter than P25 for not_applicable cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2025
CompletedFirst Posted
Study publicly available on registry
July 18, 2025
CompletedStudy Start
First participant enrolled
August 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 22, 2026
January 1, 2026
11 months
July 9, 2025
January 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of the SMART Intervention
Feasibility will be assessed by the proportion of participants using TAPPT® adherence monitoring for the duration of therapy and the proportion completing all available biweekly surveys.
3 months from intervention initiation
Acceptability of the SMART Intervention
Acceptability will be measured by participant ratings on the System Usability Scale (0-100; higher scores indicating greater usability).
3 months from intervention initiation
Secondary Outcomes (6)
Patient-Reported Adherence to OAT
Baseline and Biweekly through 3 months post-intervention initiation
TAPPT®-Monitored Adherence
Continuous monitoring through 3 months post-intervention initiation
Patient-Reported Quality of Life
Baseline and 3 months post-intervention initiation
Symptom Burden
Biweekly through 3 months post-intervention initiation
Financial Worry
Baseline and 3 months post-intervention initiation
- +1 more secondary outcomes
Study Arms (1)
SMART Intervention Arm
EXPERIMENTALParticipants 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.
Interventions
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
You may qualify if:
- Must speak English or Spanish
- 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.
You may not qualify if:
- Have an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Chao Family Comprehensive Cancer Center and Ambulatory Care building
Irvine, California, 92612, United States
UCI Health Cancer Center - Newport
Newport Beach, California, 92627, United States
UCI Health Pacific Breast Care Center
Newport Beach, California, 92627, United States
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
UCI Health - Yorba Linda
Yorba Linda, California, 92886, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Aarushi Madan, BS
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Radiology
Study Record Dates
First Submitted
July 9, 2025
First Posted
July 18, 2025
Study Start
August 26, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share