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

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.

• Best Practice (Other), also known as standard of care, standard therapy: Receive standard of care
• Informational Intervention (Other): Receive reminders
• Medical Device Usage and Evaluation (Other): Receive a SMRxT smart pill bottle
• Quality-of-Life Assessment (Other), also known as Quality of Life Assessment: Ancillary studies
• Survey Administration (Other): Ancillary studies

Primary outcomes

• Medication adherence [From baseline up to 90 days]: 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.

Secondary outcomes

• End-user engagement by patients and their oncology team [From baseline up to 90 days]: 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.
• Acceptability [From baseline up to 90 days]: 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.

Other outcomes

• Symptom burden [From baseline up to 90 days]: Will be measured using an adapted version of the National-Comprehensive Cancer Network Functional Assessment of Cancer Therapy Breast Cancer Symptom index (NCCN-FACT FBSI-16).
• Self-efficacy for managing symptoms [From baseline up to 90 days]: Will be measured by 4-item PROMIS Item Bank version 1.0.

Sex: Female, ages: 18 Years to any

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

• Informed Consent Form (PDF, 2022-06-05)

• Ilana Graetz, PhD, Principal investigator, Emory University Hospital/Winship Cancer Institute

NIH grants: P30CA138292