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

Status
Closed
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Eligibility
18 Years and older, Female
Study Type
Health services research
NCT ID
NCT05086731
Protocol IDs
EU5395-21 (primary)
NCI-2021-09125
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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

  1. Age >= 18 years
  2. Breast cancer
  3. English speaking
  4. New or existing prescription for capecitabine/Xeloda
  5. Willingness and ability of the subject to comply with study procedures
  6. Have a mobile phone with text message
  7. 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... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.