Leveraging Mobile Health for the Improvement of Oral Chemotherapy Adherence among Women with Breast Cancer

Active:	No
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05086731
Trial Phases:		Protocol IDs:	EU5395-21 (primary) NCI-2021-09125
Eligibility:	18 Years and older, Female	Study Type:	Health services research
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05086731

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.

**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... Click here to learn more about clinical trials.