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Study was terminated due to lack of funding
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.
This is a randomized, controlled pilot study to introduce eMedonline telemonitoring technology to CML patients taking Gleevec or Tasigna. eMedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. All data will be available to research staff for remote review via Web interface. Adverse events and non-adherence will prompt interventions including supportive care counseling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eMedonline access | Experimental | patients will be followed for 3 months with access to eMedonline |
|
| no access to eMedonline | Active Comparator | patients will be followed for 3 months with no access to eMedonline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no access to eMedonline | Behavioral | patients will be followed for 3 months but will not use eMedonline |
|
| Measure | Description | Time Frame |
|---|---|---|
| eMedonline will be used to measure non-compliance in taking oral drug regimens. | Patients are stratified to one of two groups: Group 1 is pateints on Gleevec or Tasigna who have been on drug less than 6 months; Group 2 is patients on Gleevec or Tasigna who have been on drug for equal to or more than 6 months. Group 1 is then divided into 2 groups: one using eMedonline for 3 months and the other not using eMedonline for 3 months. A crossover survey and pill counts will be done at the 3 month timepoint and then the groups will switch their access status to eMedonline. | at 6 months, non-compliance will be measured in each arm of study |
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Inclusion Criteria:
Total bilirubin < 1.5 xULN SGOT and SGPT <2.5 x ULN ANC > 1.5 Platlets > 100,000
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wehbie, MD | Rex Cancer Center - Wakefield | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Rex Cancer Center - Wakefield |
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| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| eMedonline access | Behavioral | patients will be given access to eMedonline use for 3 months |
|
|
| Raleigh |
| North Carolina |
| 27614 |
| United States |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |