Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy: A Pilot Feasibility Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- Feasibility of the SMART Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring (Behavioral)
结局指标
主要结局
Feasibility of the SMART Intervention
时间窗: 3 months from intervention initiation
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.
Acceptability of the SMART Intervention
时间窗: 3 months from intervention initiation
Acceptability will be measured by participant ratings on the System Usability Scale (0-100; higher scores indicating greater usability).
Feasibility and Acceptability of the SMART Intervention
时间窗: 3 months from intervention initiation
The primary aim is to examine the feasibility and acceptability of SMART to monitor OAT adherence. 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. Acceptability will be measured by participant ratings on the System Usability Scale (0-100; higher scores indicating greater usability).
次要结局
- 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)
- Patient-Reported Adherence to OAT(Baseline and Biweekly through 3 months post-intervention initiation)
- Healthcare Utilization(3 months from intervention initiation)
- 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)
- Healthcare Utilization(3 months from intervention initiation)
研究者
Gelareh Sadigh
Associate Professor of Radiology
University of California, Irvine