Mobile Health Intervention for Breast Cancer

Recruiting at 3 trial locations

Overseen By Ilana Graetz, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Capecitabine

Disqualifiers: ECOG status > 2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

33 Participants Needed

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

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a SMRxT smart pill bottle and report symptoms weekly during 3-week capecitabine/Xeloda treatment cycles

12 weeks

Weekly symptom reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Mobile Health Device

Trial Overview The 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

Group I: Group I (SMRxT smart pill bottle) Experimental Treatment 4 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 Control 3 Interventions

Patients receive a SMRxT smart pill bottle and standard of care.

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+