Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

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: Chronic Myeloid Leukemia
• Intervention / Treatment: Behavioral: eMedonline access; Behavioral: no access to eMedonline

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): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Healthcare
    • Raleigh, North Carolina, United States, 27607
      • Rex Cancer Center
    • Raleigh, North Carolina, United States, 27614
      • Rex Cancer Center - Wakefield

Participation Criteria

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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: electronic diary; Telemonitoring system; e-diary
Other: 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.	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.	at 6 months, non-compliance will be measured in each arm of study

Collaborators and Investigators

• Sponsor: Rex Cancer Center, Raleigh, NC
• Collaborators: Novartis Pharmaceuticals; Leap of Faith Technologies
• Investigators: Principal Investigator: Robert Wehbie, MD, Rex Cancer Center - Wakefield

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 8, 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, 2016

More Information

Terms related to this study

• Keywords: Chronic Myeloid Leukemia; Chronic Phase CML
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: RexCCWF1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO