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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Rex Cancer Center, Raleigh, NC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Rex Cancer Center, Raleigh, NC
ClinicalTrials.gov Identifier:
NCT01490775
First received: October 14, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Chronic Phase CML
Behavioral: no access to eMedonline
Behavioral: eMedonline access

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy

Resource links provided by NLM:


Further study details as provided by Rex Cancer Center, Raleigh, NC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 48
Study Start Date: April 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
eMedonline access Behavioral: eMedonline access
patients will be given access to eMedonline use for 3 months
Other Names:
  • Telemonitoring system
  • e-diary
  • electronic diary
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:
  • Telemonitoring system
  • e-diary
  • electronic diary

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490775

Contacts
Contact: Robert Wehbie, MD 919-784-1275 saliba@med.unc.edu
Contact: Susan Wilkinson, RN

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Olga Frankfort, MD       o-frankfurt@northwestern.edu   
United States, North Carolina
Rex Cancer Center - Wakefield Recruiting
Raleigh, North Carolina, United States, 27614
Contact: Susan Wilkinson, RN    919-570-7630    susan.wilkinson@rexhealth.com   
Sponsors and Collaborators
Rex Cancer Center, Raleigh, NC
Northwestern University
Investigators
Principal Investigator: Robert Wehbie, MD Rex Cancer Center - Wakefield
  More Information

No publications provided

Responsible Party: Rex Cancer Center, Raleigh, NC
ClinicalTrials.gov Identifier: NCT01490775     History of Changes
Other Study ID Numbers: CAMN107AUS12T
Study First Received: October 14, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rex Cancer Center, Raleigh, NC:
Chronic Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014