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NCT Number: NCT05086731

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

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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Breast Diseases Breast Neoplasms Localized Breast Carcinoma Metastatic Breast Cancer Neoplasms Neoplasms by Site Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Triple-Negative Breast Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Informational intervention

Other

Receive reminders

Medical Device Usage and Evaluation

Other

Receive a SMRxT smart pill bottle

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Medication adherence

    Time frame: 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 outcomes

  1. End-user engagement by patients and their oncology team

    Time frame: 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.

  2. Acceptability

    Time frame: 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.

Other outcomes

  1. Symptom burden

    Time frame: From baseline up to 90 days

    Will be measured using an adapted version of the National-Comprehensive Cancer Network Functional Assessment of Cancer Therapy Breast Cancer Symptom index (NCCN-FACT FBSI-16).

  2. Self-efficacy for managing symptoms

    Time frame: From baseline up to 90 days

    Will be measured by 4-item PROMIS Item Bank version 1.0.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • NRG Oncology
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 21, 2021
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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