Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy

Rex Cancer Center, Raleigh, NC27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Phase CML

Interventions

no access to eMedonlineBEHAVIORAL

patients will be followed for 3 months but will not use eMedonline

eMedonline accessBEHAVIORAL

patients will be given access to eMedonline use for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Northwestern University

Chicago, Illinois, United States

Rex Cancer Center - Wakefield

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: at 6 months, non-compliance will be measured in each arm of study

Data from ClinicalTrials.gov

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