Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib) Therapy

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Behavioral: no access to eMedonline
* Behavioral: eMedonline access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older. Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily ECOG Performance status 0, 1, or 2 Adequate end organ function, defined as: Total bilirubin < 1.5 xULN SGOT and SGPT <2.5 x ULN Creatinine < 1.5 x ULN ANC > 1.5 Platelets > 100,000 Female patients of child bearing potential must have a negative urine or serum pregnancy test at screening. Patient is able to read and speak English Patient is willing and able to use a cell phone Written, voluntary informed consent Exclusion Criteria: Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eMedonline access<br>patients will have access to eMedonline access for 3 months | Behavioral: eMedonline access<br>* patients will be given access to eMedonline use for 3 months<br>* Other names: electronic diary;|
| Other: no access to eMedonline<br>patients will be followed for 3 months with no access to eMedonline | Behavioral: no access to eMedonline<br>* patients will be followed for 3 months but will not use eMedonline<br>* Other names: electronic diary;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 patients 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Myeloid Leukemia, Chronic Phase CML