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

Rex Cancer Center, Raleigh, NC

Status: Terminated

Conditions: Chronic Phase CML

Treatments: Behavioral: eMedonline access; Behavioral: no access to eMedonline

Study type: Interventional

Funder types: Other

Identifiers

NCT01490775

CAMN107AUS12T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

eMedonline access

Experimental group

Description:

patients will be followed for 3 months with access to eMedonline

Treatment:

Behavioral: eMedonline access

no access to eMedonline

Active Comparator group

Description:

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

Treatment:

Behavioral: no access to eMedonline