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Leveraging Mobile Health for the Improvement of Oral Chemotherapy Adherence among Women with Non-metastatic Triple Negative Breast Cancer

Status
Active
Cancer Type
Breast Cancer
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 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.

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. Non-metastatic triple negative breast cancer
  3. English speaking
  4. New or existing prescription for capecitabine/Xeloda who get it filled at the Emory Specialty Pharmacy (within the first 3 cycles of use)
  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.