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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Phase CML

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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eMedonline access

patients will be followed for 3 months with access to eMedonline

Group Type EXPERIMENTAL

eMedonline access

Intervention Type BEHAVIORAL

patients will be given access to eMedonline use for 3 months

no access to eMedonline

patients will be followed for 3 months with no access to eMedonline

Group Type ACTIVE_COMPARATOR

no access to eMedonline

Intervention Type BEHAVIORAL

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

Interventions

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no access to eMedonline

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

Intervention Type BEHAVIORAL

eMedonline access

patients will be given access to eMedonline use for 3 months

Intervention Type BEHAVIORAL

Other Intervention Names

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Telemonitoring system e-diary electronic diary Telemonitoring system e-diary electronic diary

Eligibility Criteria

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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