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Brief Title: Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
Official Title: THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
Study ID: NCT05086731
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Grady Memorial Hospital, Atlanta, Georgia, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
Name: Ilana Graetz, PhD
Affiliation: Emory University Hospital/Winship Cancer Institute
Role: PRINCIPAL_INVESTIGATOR