Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy (SMART pilot)

University of California Irvine (UCI)

Status: Enrolling

Conditions: Neoplasms; Cancer

Treatments: Behavioral: SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07073807

UCI-25-83 (Other Identifier)

7375

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

SMART Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring