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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 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

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,456 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,506 Total Patients Enrolled

50 Trials studying Breast Cancer

110,785 Patients Enrolled for Breast Cancer

Emory UniversityLead Sponsor

1,638 Previous Clinical Trials

2,560,499 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this clinical experiment?

"Affirmative, the information on clinicaltrials.gov states that this study is actively recruiting participants. This experiment had its inception on October 22nd 2021 and was most recently updated on April 1st 2022; with a goal of enrolling 40 patients from 3 distinct sites."

Answered by AI

Is this experiment currently recruiting participants?

"The clinical trial is recruiting, as demonstrated by the records hosted on clinicaltrials.gov. This undertaking was initiated on October 22nd 2021 and last modified April 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer

Ilana Graetz 2021. "Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05086731.