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

Emory University

Status: Completed

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma; Prognostic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Localized Breast Carcinoma; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Metastatic Breast Cancer

Treatments: Other: Survey Administration; Other: Informational Intervention; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Medical Device Usage and Evaluation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05086731

P30CA138292 (U.S. NIH Grant/Contract)

STUDY00002985

EU5395-21 (Other Identifier)

NCI-2021-09125 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Group I (SMRxT smart pill bottle)

Experimental group

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Quality-of-Life Assessment

Other: Informational Intervention

Other: Survey Administration

Group II (standard of care)

Active Comparator group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Other: Best Practice

Other: Survey Administration