33 Participants Needed

Mobile Health Intervention for Breast Cancer

Recruiting at 3 trial locations
IG
Overseen ByIlana Graetz, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Emory University
Must be taking: Capecitabine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

IG

Ilana Graetz, PhD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

This trial is for English-speaking women over 18 with non-metastatic triple negative breast cancer who are prescribed capecitabine/Xeloda. Participants must be able to follow study procedures, have text messaging on their mobile phone, and understand the study's risks and benefits.

Inclusion Criteria

I am prescribed capecitabine/Xeloda.
Evidence of an online informed consent indicating awareness of the risk and benefits of study participation
I have been diagnosed with breast cancer.
See 4 more

Exclusion Criteria

My daily activity is significantly limited due to my health.
Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment

Treatment Details

Interventions

  • Mobile Health Device
Trial OverviewThe trial tests if a smart pill bottle (SMRxT) can help patients take oral chemotherapy on time and monitor symptoms. It assesses how practical and acceptable this mobile health device is for improving medication adherence.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (SMRxT smart pill bottle)Experimental Treatment4 Interventions
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: Group II (standard of care)Active Control3 Interventions
Patients receive a SMRxT smart pill bottle and standard of care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

NRG Oncology

Collaborator

Trials
242
Recruited
105,000+