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Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

Primary Purpose

Chronic Myeloid Leukemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
no access to eMedonline
eMedonline access
Sponsored by
Rex Cancer Center, Raleigh, NC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Myeloid Leukemia focused on measuring Chronic Myeloid Leukemia, Chronic Phase CML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Healthcare
  • Rex Cancer Center
  • Rex Cancer Center - Wakefield

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

eMedonline access

no access to eMedonline

Arm Description

patients will have access to eMedonline access for 3 months

patients will be followed for 3 months with no access to eMedonline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2011
Last Updated
August 9, 2018
Sponsor
Rex Cancer Center, Raleigh, NC
Collaborators
Novartis Pharmaceuticals, Leap of Faith Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT01490983
Brief Title
Telemonitoring Study - for Chronic Myeloid Leukemia (CML)
Official Title
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib) Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of funding
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rex Cancer Center, Raleigh, NC
Collaborators
Novartis Pharmaceuticals, Leap of Faith Technologies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Chronic Myeloid Leukemia, Chronic Phase CML

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eMedonline access
Arm Type
Experimental
Arm Description
patients will have access to eMedonline access for 3 months
Arm Title
no access to eMedonline
Arm Type
Other
Arm Description
patients will be followed for 3 months with no access to eMedonline
Intervention Type
Behavioral
Intervention Name(s)
no access to eMedonline
Other Intervention Name(s)
Telemonitoring system, e-diary, electronic diary
Intervention Description
patients will be followed for 3 months but will not use eMedonline
Intervention Type
Behavioral
Intervention Name(s)
eMedonline access
Other Intervention Name(s)
Telemonitoring system, e-diary, electronic diary
Intervention Description
patients will be given access to eMedonline use for 3 months
Primary Outcome Measure Information:
Title
eMedonline will be used to measure non-compliance in taking oral drug regimens.
Description
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.
Time Frame
at 6 months, non-compliance will be measured in each arm of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wehbie, MD
Organizational Affiliation
Rex Cancer Center - Wakefield
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Healthcare
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Rex Cancer Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Rex Cancer Center - Wakefield
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27614
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

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