Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
NCT ID: NCT05086731
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2021-10-22
2024-03-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group I (SMRxT smart pill bottle)
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.
Informational Intervention
Receive reminders
Medical Device Usage and Evaluation
Receive a SMRxT smart pill bottle
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Group II (standard of care)
Patients receive a SMRxT smart pill bottle and standard of care.
Best Practice
Receive standard of care
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Best Practice
Receive standard of care
Informational Intervention
Receive reminders
Medical Device Usage and Evaluation
Receive a SMRxT smart pill bottle
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
18 Years
FEMALE
No
Sponsors
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NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Emory University
OTHER
Responsible Party
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Ilana Graetz
Principal Investigator
Principal Investigators
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Ilana Graetz, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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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
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2021-09125
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU5395-21
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00002985
Identifier Type: -
Identifier Source: org_study_id
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