Leveraging Mobile Health for the Improvement of Oral Chemotherapy Adherence among Women with Breast Cancer
Breast Cancer
Unknown Primary
18 Years and older, Female
EU5395-21 (primary)
NCI-2021-09125
Summary
This clinical trial evaluates the feasibility and acceptability of a mobile health device in improving oral chemotherapy adherence in women with breast cancer. A mobile health device, called SMRxT smart pill bottle may help doctors to remind patients to take medicine on time and monitor their symptoms.
Objectives
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
- 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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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