Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer

Study Overview
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Brief Summary
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This clinical trial evaluates the feasibility and acceptability of a mobile health device in improving oral chemotherapy adherence in women with triple negative breast cancer that has not spread to other places in the body (non-metastatic). A mobile health device, called SMRxT smart pill bottle may help doctors to remind patients to take medicine on time and monitor their symptoms.

Detailed Description
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PRIMARY OBJECTIVES: I. Feasibility. II. Acceptability. III. Capecitabine/Xeloda adherence. EXPLORATORY OBJECTIVES: I. Symptom burden. II. Patent physician communication. III. Quality of life. IV. Self-efficacy for managing symptoms. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles. GROUP II: Patients receive standard of care. After completion of study, patients are followed up for 90 days after the initiation of capecitabine/Xeloda.

Official Title
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THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer

Conditions
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Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Localized Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma, Metastatic Breast Cancer

Intervention / Treatment
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* Other: Best Practice
* Other: Informational Intervention
* Other: Medical Device Usage and Evaluation
* Other: Quality-of-Life Assessment
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years Breast cancer English speaking New or existing prescription for capecitabine/Xeloda Willingness and ability of the subject to comply with study procedures Have a mobile phone with text message Evidence of an online informed consent indicating that the subject is aware of the risk and benefits of study participation Exclusion Criteria: Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment Eastern Cooperative Oncology Group (ECOG) performance status > 2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (SMRxT smart pill bottle)<br>Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles. | Other: Informational Intervention<br>* Receive reminders<br>Other: Medical Device Usage and Evaluation<br>* Receive a SMRxT smart pill bottle<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (standard of care)<br>Patients receive a SMRxT smart pill bottle and standard of care. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | Proportion of times each patient took her scheduled medication during the 3-month study. For each patient, will operationalize adherence as the number of times that the pill monitor recorded a dose taken for each day that the patient was in the study and supposed to take the pill. Days during which patients were off cycle, advised by their provider to temporarily stop the medication, or hospitalized will be deducted from the total days in the study. | From baseline up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-user engagement by patients and their oncology team | Will measure patient's use of the smart pill bottle, their response to weekly symptoms text message questions, response to the smart reminders, and response to the adherence reason text message question. In addition, will also measure and evaluate the provider response to any adherence or symptom alerts triggered during the intervention. | From baseline up to 90 days | 
| Acceptability | Will be measured using survey questions about the intervention after the 90-day intervention. Acceptability and usability will be determined using the System Usability Scale. | From baseline up to 90 days |