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Trial record 62 of 6999 for:    Oral Cancer | ( Map: United States )

Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy

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ClinicalTrials.gov Identifier: NCT01490775
Recruitment Status : Terminated (Study was terminated due to lack of funding)
First Posted : December 13, 2011
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Phase CML Behavioral: no access to eMedonline Behavioral: eMedonline access Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy
Study Start Date : April 2009
Actual Primary Completion Date : February 12, 2015
Actual Study Completion Date : June 30, 2015


Arm Intervention/treatment
Experimental: eMedonline access
patients will be followed for 3 months with access to eMedonline
Behavioral: eMedonline access
patients will be given access to eMedonline use for 3 months
Other Names:
  • Telemonitoring system
  • e-diary
  • electronic diary

Active Comparator: 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




Primary Outcome Measures :
  1. 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 ]

    Patients are stratified to one of two groups: Group 1 is pateints 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 ANC > 1.5 Platlets > 100,000

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490775


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, North Carolina
Rex Cancer Center - Wakefield
Raleigh, North Carolina, United States, 27614
Sponsors and Collaborators
Rex Cancer Center, Raleigh, NC
Northwestern University
Investigators
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Principal Investigator: Robert Wehbie, MD Rex Cancer Center - Wakefield

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Responsible Party: Rex Cancer Center, Raleigh, NC
ClinicalTrials.gov Identifier: NCT01490775     History of Changes
Other Study ID Numbers: CAMN107AUS12T
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: April 2017

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

Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action