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Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

This study is currently recruiting participants.
Verified December 2012 by Rex Cancer Center, Raleigh, NC
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Leap of Faith Technologies
Information provided by (Responsible Party):
Rex Cancer Center, Raleigh, NC
ClinicalTrials.gov Identifier:
NCT01490983
First received: December 8, 2011
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  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 Myeloid Leukemia
 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:

U.S. FDA Resources

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 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.



Estimated Enrollment: 48
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eMedonline access
patients will have access to eMedonline access for 3 months
 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
    • Creatinine < 1.5 x ULN
    • ANC > 1.5
    • Platelets > 100,000
  • Patient is able to read and speak English
  • 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: NCT01490983

Contacts
Contact: Robert Wehbie, MD 919-784-1275 robert.wehbie@rexhealth.com
Contact: Anderson Black, RN

Locations
United States, North Carolina
UNC Healthcare Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Rex Cancer Center - Wakefield Recruiting
Raleigh, North Carolina, United States, 27614
Contact: Anderson Black, RN     919-570-7630     anderson.black@rexhealth.com    
Rex Cancer Center Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Reynaldo Garcia, RN     919-784-7048     reynaldo.garcia@rexhealth.com    
Sponsors and Collaborators
Rex Cancer Center, Raleigh, NC
Novartis Pharmaceuticals
Leap of Faith Technologies
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: NCT01490983     History of Changes
Other Study ID Numbers: RexCCWF1
Study First Received: December 8, 2011
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
 Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013