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| ID | Type | Description | Link |
|---|---|---|---|
| JT 19501 | Other Identifier | JeffTrial Number |
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This clinical trial studies how well a mobile intervention consisting of a text messaging program and an electronic "smart" pill bottle with medication reminders works to improve adherence to oral anti-cancer medications among patients with acute myeloid leukemia (AML). Medication adherence is how well patients take medications as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a barrier to effective treatment. Collecting feedback on patient experiences using the mobile intervention may help doctors design new methods and material for providing educational information to AML patients who are taking oral anti-cancer medications.
PRIMARY OBJECTIVE:
I. To examine the feasibility, acceptability and preliminary efficacy of txt4AML in a pilot single arm study.
SECONDARY OBJECTIVE:
I. To explore the association between overall treatment responses and real-time oral anti-cancer medication (OAM) adherence.
EXPLORATORY OBJECTIVE:
I. To summarize and assess other patient-reported outcomes, collected either as patient chart review or through self-reported survey, as well as the patient post-intervention interviews.
OUTLINE:
Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (text messages, smart pill bottle) | Experimental | Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message-Based Navigation Intervention | Other | Receive interactive text messaging. |
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| Measure | Description | Time Frame |
|---|---|---|
| Real-time oral anticancer medication (OAM) medication adherence | Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals. | At baseline |
| Real-time oral anticancer medication (OAM) medication adherence | Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals. | at 1 month |
| Real-time oral anticancer medication (OAM) medication adherence | Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals. | At 2 months |
| MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response | Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence. | At baseline |
| MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (CR) | Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence | At baseline, 1, and 2 months |
| Incomplete blood count recovery (Cri) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States | ||
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| Behavioral, Psychological or Informational Intervention | Other | Receive medication reminders via smart pill bottle |
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| Survey Administration | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
| At 1 month |
| MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response | Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence. | At 2 months |
Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
| At baseline, 1, and 2 months |
| Partial remissions (PR) | Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence. | At baseline, 1, and 2 months |
| Morphologic leukemia-free state (MLFS) | Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence. | At baseline, 1, and 2 months |
| Thomas Jefferson University Hospital |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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