Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT07073807
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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.

Primary Outcome Measure

Feasibility of the SMART Intervention [ Time Frame: 3 months from intervention initiation ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center and Ambulatory Care buildingIrvineCalifornia92612
Aarushi Madan, BS
[email protected]
949-745-5066
Gelareh Sadigh, MD (PRINCIPAL_INVESTIGATOR)
UCI Health Cancer Center - NewportNewport BeachCalifornia92627
Aarushi Madan, BS
[email protected]
949-745-5066
Gelareh Sadigh, MD (PRINCIPAL_INVESTIGATOR)
UCI Health Pacific Breast Care CenterNewport BeachCalifornia92627
Aarushi Madan, BS
[email protected]
949-745-5066
Gelareh Sadigh, MD (PRINCIPAL_INVESTIGATOR)
UCI Health Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Aarushi Madan, BS
[email protected]
949-745-5066
Gelareh Sadigh, MD (PRINCIPAL_INVESTIGATOR)
UCI Health - Yorba LindaYorba LindaCalifornia92886
Aarushi Madan, BS
[email protected]
949-745-5066
Gelareh Sadigh, MD (PRINCIPAL_INVESTIGATOR)

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Chao Family Comprehensive Cancer Center and Ambulatory Care building· Irvine, CAUCI Health Cancer Center - Newport· Newport Beach, CAUCI Health Pacific Breast Care Center· Newport Beach, CAUCI Health Chao Family Comprehensive Cancer Center· Orange, CAUCI Health - Yorba Linda· Yorba Linda, CA

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