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

Not Applicable

Active, not recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Localized Breast Carcinoma
• Interventions: Other: Informational Intervention; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Medical Device Usage and Evaluation; Other: Survey Administration

• Registration Number: NCT05086731
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Feasibility. II. Acceptability. III. Capecitabine/Xeloda adherence.

EXPLORATORY OBJECTIVES:

I. Symptom burden. II. Patent physician communication. III. Quality of life. IV. Self-efficacy for managing symptoms.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: 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: Patients receive standard of care.

After completion of study, patients are followed up for 90 days after the initiation of capecitabine/Xeloda.

Study Timeline

• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-21
• Study Start: 2021-10-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Age >= 18 years
• Breast cancer
• English speaking
• New or existing prescription for capecitabine/Xeloda
• Willingness and ability of the subject to comply with study procedures
• Have a mobile phone with text message
• Evidence of an online informed consent indicating that the subject is aware of the risk and benefits of study participation

Exclusion Criteria

• Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status > 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (standard of care)	Survey Administration	Patients receive a SMRxT smart pill bottle and standard of care.
Group II (standard of care)	Quality-of-Life Assessment	Patients receive a SMRxT smart pill bottle and standard of care.
Group I (SMRxT smart pill bottle)	Informational Intervention	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 I (SMRxT smart pill bottle)	Survey Administration	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 I (SMRxT smart pill bottle)	Quality-of-Life Assessment	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 I (SMRxT smart pill bottle)	Medical Device Usage and Evaluation	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 (standard of care)	Best Practice	Patients receive a SMRxT smart pill bottle and standard of care.

Primary Outcome Measures

Name	Time	Method
Medication adherence	From baseline up to 90 days	Proportion of times each patient took her scheduled medication during the 3-month study. For each patient, will operationalize adherence as the number of times that the pill monitor recorded a dose taken for each day that the patient was in the study and supposed to take the pill. Days during which patients were off cycle, advised by their provider to temporarily stop the medication, or hospitalized will be deducted from the total days in the study.

Secondary Outcome Measures

Name	Time	Method
Acceptability	From baseline up to 90 days	Will be measured using survey questions about the intervention after the 90-day intervention. Acceptability and usability will be determined using the System Usability Scale.
End-user engagement by patients and their oncology team	From baseline up to 90 days	Will measure patient's use of the smart pill bottle, their response to weekly symptoms text message questions, response to the smart reminders, and response to the adherence reason text message question. In addition, will also measure and evaluate the provider response to any adherence or symptom alerts triggered during the intervention.

Trial Locations

Locations (4)

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States