Breast Cancer Clinical Trial
Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Age >= 18 years
Breast cancer
English speaking
New or existing prescription for capecitabine/Xeloda who get it filled at the Emory Specialty Pharmacy (within the first 3 cycles of use)
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
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There are 3 Locations for this study
Atlanta Georgia, 30308, United States More Info
Principal Investigator
Atlanta Georgia, 30322, United States More Info
Principal Investigator
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