Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib) Therapy
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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
Robert Wehbie, MD
Rex Cancer Center - Wakefield
United States: Institutional Review Board
|Rex Cancer Center||Raleigh, North Carolina 27607|
|Rex Cancer Center - Wakefield||Raleigh, North Carolina 27614|
|UNC Healthcare||Chapel Hill, North Carolina 27599|