← Back to Search

Mobile Health Intervention for Breast Cancer

N/A

Waitlist Available

Led By Ilana Graetz, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New or existing prescription for capecitabine/Xeloda

Diagnosis of breast cancer

Must not have

Eastern Cooperative Oncology Group (ECOG) performance status > 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a mobile health device can help women with triple negative breast cancer who are taking oral chemotherapy to remember to take their medicine on time and monitor their symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not directly related to side effects of the intervention itself, participants may experience issues common with oral chemotherapy like nausea, vomiting, diarrhea, fatigue or hand-foot syndrome due to capecitabine/Xeloda.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am prescribed capecitabine/Xeloda.

Select...

I have been diagnosed with breast cancer.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My daily activity is significantly limited due to my health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medication adherence

Secondary study objectives

Acceptability

End-user engagement by patients and their oncology team

Other study objectives

Self-efficacy for managing symptoms

Symptom burden

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met