Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
4 other identifiers
interventional
33
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedStudy Start
First participant enrolled
October 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2024
CompletedJune 17, 2025
June 1, 2025
1.8 years
October 19, 2021
June 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
End-user engagement by patients and their oncology team
From baseline up to 90 days
Acceptability
From baseline up to 90 days
Other Outcomes (2)
Symptom burden
From baseline up to 90 days
Self-efficacy for managing symptoms
From baseline up to 90 days
Study Arms (2)
Group I (SMRxT smart pill bottle)
EXPERIMENTALPatients 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 (standard of care)
ACTIVE COMPARATORPatients receive a SMRxT smart pill bottle and standard of care.
Interventions
Receive standard of care
Receive a SMRxT smart pill bottle
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- NRG Oncologycollaborator
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (4)
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilana Graetz, PhD
Emory University Hospital/Winship Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 19, 2021
First Posted
October 21, 2021
Study Start
October 22, 2021
Primary Completion
August 14, 2023
Study Completion
March 6, 2024
Last Updated
June 17, 2025
Record last verified: 2025-06