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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09125 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EU5395-21 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| NRG Oncology | OTHER |
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (SMRxT smart pill bottle) | Experimental | 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. |
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| Group II (standard of care) | Active Comparator | Patients receive a SMRxT smart pill bottle and standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | 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. | From baseline up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| End-user engagement by patients and their oncology team | 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. | From baseline up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom burden | 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). | From baseline up to 90 days |
| Self-efficacy for managing symptoms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilana Graetz, PhD | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital Midtown |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2022 | May 10, 2023 |
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| Informational Intervention | Other | Receive reminders |
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| Medical Device Usage and Evaluation | Other | Receive a SMRxT smart pill bottle |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Acceptability | 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. | From baseline up to 90 days |
Will be measured by 4-item PROMIS Item Bank version 1.0.
| From baseline up to 90 days |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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