CancerSMART pilotNCT07073807
Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy
A study testing SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring in people with Cancer and Neoplasms, run by University of California, Irvine at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Aug 2025to 6 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Chao Family Comprehensive Cancer Center and Ambulatory Care building
Irvine, California, 92612
UCI Health Cancer Center - Newport
Newport Beach, California, 92627
UCI Health Pacific Breast Care Center
Newport Beach, California, 92627
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, 92868
UCI Health - Yorba Linda
Yorba Linda, California, 92886
About this study
Official title: Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy: A Pilot Feasibility Clinical Trial
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.
Read the detailed 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.
- Being tested
- SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring
- Keywords
- Cancer, Oral Anticancer Therapy, Medication Adherence, Mobile Health, Health Literacy, Symptom Management, Health-Related Social Needs, Financial Toxicity, adherence, symptom burden, reminder
- Medical subject headings
- Neoplasms, Medication Adherence, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs MonitoringBehavioural
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 group | Role | What they receive |
|---|---|---|
| SMART Intervention Arm | Experimental | 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. Receives: Behavioral: SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 months from intervention initiation
Secondary outcomes (6)
Patient-Reported Adherence to OAT
Patient-reported adherence assessed biweekly using the PROMIS Medication Adherence Scale (PMAS) single-item question about OAT adherence, scored on a 1-5 scale with average score transformed to 0-100. ≥80 score is considered adherent.
Measured: Baseline and Biweekly through 3 months post-intervention initiation
TAPPT®-Monitored Adherence
Adherence measured by the proportion of OAT doses recorded through TAPPT® smart labels over the 3-month intervention period.
Measured: Continuous monitoring through 3 months post-intervention initiation
Patient-Reported Quality of Life
Patient-reported QOL measured at baseline and 3 months using the PROMIS-10 Global Health instrument, scored 0-100, with higher scores indicating better QOL.
Measured: Baseline and 3 months post-intervention initiation
Symptom Burden
Symptom burden assessed biweekly using the MD Anderson Symptom Inventory (MDASI) severity items (0-10 scale; higher scores indicating greater symptom severity).
Measured: Biweekly through 3 months post-intervention initiation
Financial Worry
Financial worry measured using the Comprehensive Score for Financial Toxicity (COST) at baseline and 3 months; scores range from 0-44, with lower scores indicating higher financial distress.
Measured: Baseline and 3 months post-intervention initiation
Healthcare Utilization
Healthcare utilization including the number of oncology office visits, urgent care/emergency department visits, and hospitalizations, collected from electronic medical records over the 3-month intervention period.
Measured: 3 months from intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start26 Aug 2025
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive the SMART intervention, which includes TAPPT® smart labels for real-time OAT adherence monitoring, biweekly symptom and adherence surveys, personalized reminders, missed/extra dose management, symptom support, and monthly financial and social needs screening. There is no control or comparison arm in this single-arm feasibility study.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gelareh Sadigh, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073807
- Sponsor's protocol ID
- 7375
- Other IDs
- UCI-25-83
- Acronym
- SMART pilot
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Intervention to Improve Adherence to Oral Anticancer Therapy: A Pilot Feasibility Clinical Trial
- ClinicalTrials.gov ID
- NCT07073807
- Acronym / sponsor ID
- SMART pilot / 7375
- Keywords
- Cancer, Oral Anticancer Therapy, Medication Adherence, Mobile Health, Health Literacy, Symptom Management, Health-Related Social Needs, Financial Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive the SMART intervention, which includes TAPPT® smart labels for real-time OAT adherence monitoring, biweekly symptom and adherence surveys, personalized reminders, missed/extra dose management, symptom support, and monthly financial and social needs screening. There is no control or comparison arm in this single-arm feasibility study.
| Arm | Type | Receives |
|---|---|---|
| SMART Intervention Arm | Experimental | Behavioral: SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs MonitoringParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs MonitoringThe 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. | Behavioural | SMART Intervention Arm |
Primary outcome
Feasibility of the SMART Intervention
Time frame: 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
Time frame: 3 months from intervention initiation
Acceptability will be measured by participant ratings on the System Usability Scale (0-100; higher scores indicating greater usability).
6 secondary outcomes
Patient-Reported Adherence to OAT
Time frame: Baseline and Biweekly through 3 months post-intervention initiation
TAPPT®-Monitored Adherence
Time frame: Continuous monitoring through 3 months post-intervention initiation
Patient-Reported Quality of Life
Time frame: Baseline and 3 months post-intervention initiation
Symptom Burden
Time frame: Biweekly through 3 months post-intervention initiation
Financial Worry
Time frame: Baseline and 3 months post-intervention initiation
Healthcare Utilization
Time frame: 3 months from intervention initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Intervention using TAPPT® for Adherence, Symptom, Financial, and Social Needs Monitoring in people with Cancer and Neoplasms, run by University of California, Irvine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the SMART Intervention (time frame: 3 months from intervention initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.