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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 90 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am prescribed capecitabine/Xeloda.
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I have been diagnosed with breast cancer.
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I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Medication adherence
Secondary outcome measures
Acceptability
End-user engagement by patients and their oncology team
Other outcome measures
Self-efficacy for managing symptoms
Symptom burden

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,281 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,446 Total Patients Enrolled
50 Trials studying Breast Cancer
110,785 Patients Enrolled for Breast Cancer
Emory UniversityLead Sponsor
1,646 Previous Clinical Trials
2,564,567 Total Patients Enrolled
28 Trials studying Breast Cancer
3,028 Patients Enrolled for Breast Cancer

Media Library

Informational Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05086731 — N/A
Breast Cancer Research Study Groups: Group I (SMRxT smart pill bottle), Group II (standard of care)
Breast Cancer Clinical Trial 2023: Informational Intervention Highlights & Side Effects. Trial Name: NCT05086731 — N/A
Informational Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05086731 — N/A
~5 spots leftby Dec 2024
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