Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 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: October 18, 2013
Last verified: October 2013
  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:


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
  • ECOG Performance status 0, 1, or 2
  • 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
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test at screening.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Matthew Foster, MD    866-869-1856      
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: October 18, 2013
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 July 26, 2014