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

August 9, 2018 updated by: Rex Cancer Center, Raleigh, NC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • North Carolina
      • Raleigh, North Carolina, United States, 27614
        • Rex Cancer Center - Wakefield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eMedonline access
patients will be followed for 3 months with access to eMedonline
Behavioral: eMedonline access
patients will be given access to eMedonline use for 3 months
Other Names:
  • electronic diary
  • Telemonitoring system
  • e-diary
Active Comparator: no access to eMedonline
patients will be followed for 3 months with no access to eMedonline
Behavioral: no access to eMedonline
patients will be followed for 3 months but will not use eMedonline
Other Names:
  • electronic diary
  • Telemonitoring system
  • e-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.
Time Frame: at 6 months, non-compliance will be measured in each arm of study

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.
at 6 months, non-compliance will be measured in each arm of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rex Cancer Center, Raleigh, NC

Collaborators

Northwestern University

Investigators

  • Principal Investigator: Robert Wehbie, MD, Rex Cancer Center - Wakefield

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 12, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMN107AUS12T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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