Mobile Health App for Cancer

(SMART pilot Trial)

Recruiting at 4 trial locations

Overseen By Gelareh Sadigh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must be taking: Oral anticancer therapy

Disqualifiers: ECOG status > 2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new mobile health app, the SMART Intervention using TAPPT®, designed to help cancer patients adhere to their oral anticancer treatments and manage symptoms more effectively. It also seeks to improve communication with healthcare providers and offer support for financial and social needs. The trial seeks English or Spanish-speaking cancer patients who have started or are about to start a new oral anticancer drug, receive care at specific clinics, and own a smartphone. As an unphased trial, this study provides patients the opportunity to contribute to innovative solutions for managing cancer treatment and support.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring adherence to new oral anticancer treatments, so you may be able to continue your current medications, but it's best to confirm with the trial coordinators.

What prior data suggests that this mobile health intervention is safe for cancer patients?

Research has shown that mobile health (mHealth) apps effectively help cancer patients adhere to their treatment plans. These apps often allow patients to track symptoms and provide personalized advice for managing their condition. Studies have found that mHealth tools assist patients in taking their medication as prescribed.

While specific safety data for the SMART intervention using TAPPT® isn't detailed, mHealth apps in cancer care have generally produced positive results, such as reducing anxiety in cancer survivors. This suggests that users receive these apps well and find them helpful in managing cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for cancer, which primarily involves treatments like chemotherapy, radiation, and surgery, the SMART Intervention offers a unique approach by leveraging technology to enhance patient care. It uses TAPPT® smart labels and a web-based app for real-time tracking of oral anti-cancer therapy (OAT) adherence, which is crucial for effective treatment. Additionally, personalized text reminders and symptom management through oncology alerts help address individual patient needs, while tailored educational messages support those with low health literacy. Researchers are excited about this approach because it integrates modern technology to potentially improve adherence and patient outcomes in a more personalized and accessible way.

What evidence suggests that this mobile health intervention is effective for cancer patients?

Research shows that mobile health apps help cancer patients adhere to treatment plans and manage symptoms more effectively. In this trial, participants will 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. Studies have found that these apps encourage positive changes, making it easier for patients to take their medication on time. Other research highlights their usefulness in managing cancer symptoms and providing personalized self-care advice. Evidence also suggests that mobile health tools improve outcomes for patients who might struggle to follow their treatment plans. Overall, mobile health apps serve as a helpful tool for people with cancer to stay on track with their treatment and manage symptoms effectively. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for English and Spanish-speaking cancer patients experiencing challenges with taking oral anticancer medication, managing symptoms, or facing financial hardship. It aims to help them communicate better with their healthcare providers and support their social needs.

Inclusion Criteria

Be receiving treatment at UCI Chao Family Comprehensive Cancer Center-affiliated oncology clinics

I speak English or Spanish.

I am 18 years old or older.

Exclusion Criteria

Be participating in another clinical trial that monitors adherence or symptoms related to the newly prescribed OAT

My physical ability is limited and I cannot care for myself.

I am able to understand and consent to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

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.

3 months

Biweekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• SMART Intervention using TAPPT®

Trial Overview The study tests a mobile health intervention called TAPPT® that monitors medication adherence, symptoms, finances, and social needs of cancer patients. The goal is to improve the use of oral anticancer treatments outside clinic visits.

How Is the Trial Designed?

Group I: SMART Intervention Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11877465/

Mobile apps for cancer patients: Identifying positive ... Evidence is available on Mobile apps for cancer management being used to successfully promote behavioral changes in the areas of treatment adherence.

2. ascopubs.org ascopubs.org/doi/10.1200/CCI.24.00014

Mapping the Evidence on the Impact of mHealth ... All studies contained multiple interventions, including physical activity, tailored information for self-management of the disease, and symptom tracker.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388921000752

The effect of a mobile application on treatment adherence ... The present study results showed that the mobile application is effective in managing symptoms and increasing treatment adherence. A well-designed mobile health ...

4. mhealth.jmir.org mhealth.jmir.org/2024/1/e53652/

Integrative Review - JMIR mHealth and uHealth Using mHealth apps to monitor and manage pain was acceptable for most patients with cancer. The internal consistency of the mHealth in measuring ...

5. ons.org ons.org/publications-research/cjon/25/4/mobile-health-interventions-examining-medication-adherence-outcomes

Mobile Health Interventions: Examining Medication ... Mobile health interventions are an acceptable approach among patients with cancer and may improve adherence outcomes for those at highest risk for suboptimal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8796094/

Smart health via mHealth? Potentials of mobile health apps ... The app analysis shows that there are currently only 10 mHealth apps in German, which are specifically dedicated to breast cancer patients.

7. jmir.org jmir.org/2022/12/e39799/

Effect of Mobile Phone App–Based Interventions on Quality ... Overall, the mHealth app interventions significantly alleviated anxiety among cancer survivors, but there was high heterogeneity (SMD=−0.64, 95% ...