Trials / Completed
CompletedNCT05086731
Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
THRIVE Smart - Leveraging Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Emory University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
- Localized Breast Carcinoma
- 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
- Triple-Negative Breast Carcinoma
- Metastatic Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Best Practice | Receive standard of care |
| OTHER | Informational Intervention | Receive reminders |
| OTHER | Medical Device Usage and Evaluation | Receive a SMRxT smart pill bottle |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Survey Administration | Ancillary studies |
Timeline
- Start date
- 2021-10-22
- Primary completion
- 2023-08-14
- Completion
- 2024-03-06
- First posted
- 2021-10-21
- Last updated
- 2025-06-17
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05086731. Inclusion in this directory is not an endorsement.