Back to resultsPilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
Primary Purpose
Chronic Phase CML
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
no access to eMedonline
eMedonline access
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Phase CML focused on measuring Chronic Myeloid Leukemia
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
- Known performance status 0,1 or 2 (ECOG)
- Known adequate end organ function, defined as:
Total bilirubin < 1.5 xULN SGOT and SGPT <2.5 x ULN ANC > 1.5 Platlets > 100,000
- 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
Sites / Locations
- Northwestern University
- Rex Cancer Center - Wakefield
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
eMedonline access
no access to eMedonline
Arm Description
patients will be followed for 3 months with access to eMedonline
patients will be followed for 3 months with no access to eMedonline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01490775
First Posted
October 14, 2011
Last Updated
August 9, 2018
Sponsor
Rex Cancer Center, Raleigh, NC
Collaborators
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01490775
Brief Title
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
Official Title
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to lack of funding
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 12, 2015 (Actual)
Study Completion Date
June 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rex Cancer Center, Raleigh, NC
Collaborators
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Phase CML
Keywords
Chronic Myeloid Leukemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eMedonline access
Arm Type
Experimental
Arm Description
patients will be followed for 3 months with access to eMedonline
Arm Title
no access to eMedonline
Arm Type
Active Comparator
Arm Description
patients will be followed for 3 months with no access to eMedonline
Intervention Type
Behavioral
Intervention Name(s)
no access to eMedonline
Other Intervention Name(s)
Telemonitoring system, e-diary, electronic diary
Intervention Description
patients will be followed for 3 months but will not use eMedonline
Intervention Type
Behavioral
Intervention Name(s)
eMedonline access
Other Intervention Name(s)
Telemonitoring system, e-diary, electronic diary
Intervention Description
patients will be given access to eMedonline use for 3 months
Primary Outcome Measure Information:
Title
eMedonline will be used to measure non-compliance in taking oral drug regimens.
Description
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.
Time Frame
at 6 months, non-compliance will be measured in each arm of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Known performance status 0,1 or 2 (ECOG)
Known adequate end organ function, defined as:
Total bilirubin < 1.5 xULN SGOT and SGPT <2.5 x ULN ANC > 1.5 Platlets > 100,000
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wehbie, MD
Organizational Affiliation
Rex Cancer Center - Wakefield
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rex Cancer Center - Wakefield
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27614
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
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