THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 33
- Locations
- 4
- Primary Endpoint
- Medication adherence
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Medication adherence
Time Frame: 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
- Acceptability(From baseline up to 90 days)
- End-user engagement by patients and their oncology team(From baseline up to 90 days)
Investigators
Ilana Graetz
Principal Investigator
Emory University