Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

Not Applicable

Terminated

• Conditions: Chronic Myeloid Leukemia
• Interventions: Behavioral: eMedonline access; Behavioral: no access to eMedonline

• Registration Number: NCT01490983
• Lead Sponsor: Rex Cancer Center, Raleigh, NC

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
eMedonline access	eMedonline access	patients will have access to eMedonline access for 3 months
no access to eMedonline	no access to eMedonline	patients will be followed for 3 months with no access to eMedonline

Primary Outcome Measures

Name	Time	Method
eMedonline will be used to measure non-compliance in taking oral drug regimens.	at 6 months, non-compliance will be measured in each arm of study	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.

Trial Locations

Locations (3)

Rex Cancer Center - Wakefield; 🇺🇸 Raleigh, North Carolina, United States

UNC Healthcare; 🇺🇸 Chapel Hill, North Carolina, United States

Rex Cancer Center; 🇺🇸 Raleigh, North Carolina, United States