Trial record 1 of 51 for:    TAKE-IT
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Interventional Study to Improve Adherence to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (TAKE-IT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
pia raanani, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01768689
First received: January 8, 2013
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

Adherence to tyrosine kinase inhibitors is associated with improved outcomes in chronic myeloid leukemia patients. Hence, improved adherence might improve CML patients' prognosis.

Decreased adherence is a common problem in such patients, with non-adherence in up to 30% of patients in several studies. Recently, an emphasis has been placed on improving patient's adherence to tyrosine kinase inhibitors in these patients. However, there is no prospective high-quality evidence showing that adherence can be improved in these patients.

Therefore, the investigators hypothesize that adherence-encouraging interventions improve adherence to tyrosine kinase inhibitors in chronic myeloid leukemia patients.


Condition Intervention
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Medication Adherence
Behavioral: Adherence-encouraging interventions - Group meeting
Behavioral: Adherence-encouraging interventions - Individual meetings
Behavioral: Adherence-encouraging interventions - Monthly phone calls

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Active Adherence-Encouraging Interventions on Adherence to Tyrosine Kinase Inhibitor Treatment in Chronic Myeloid Leukemia - A Prospective Observational Multicenter Study (TAKE-IT)

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Clinically relevant change in MEMS-measured adherence [ Time Frame: From 3 months before intervention, until 3 months after starting the intervention ] [ Designated as safety issue: No ]

    Improvement in a patient's adherence from less than 90% during the initial 3 month run-in period, to 90% or more during the first 3 months of intervention.

    Definitions:

    1. Adherence above 90% was defined as clinically relevant.
    2. Adherence rate = actual calculated dose/prescribed dose.
    3. Adherence will be calculated from "medical events monitoring system" (MEMS) data which will be collected continuously throughout the first 7.5 months of the study period. MEMS is an electronic monitoring system designed to compile the dosing histories of ambulatory patients prescribed oral medications

  • General improvement in MEMS-measured adherence [ Time Frame: 3 months prior to the intervention, until 3 months after starting the intervention ] [ Designated as safety issue: No ]

    An absolute improvement of 10% in a patient's adherence, between their adherence during the initial 3 month run-in period and their adherence during the first 3 months of intervention.

    See Definitions of adherence rate and measurement of adherence in the first primary outcome description.



Secondary Outcome Measures:
  • Mean-difference in MEMS-measured adherence [ Time Frame: 3 months prior to intervention until 3 months after starting the intervention ] [ Designated as safety issue: No ]

    Mean-difference in adherence (as measured by the MEMS) between the run-in period and the first 3 months of the intervention period (paired t-test).

    The aim is to evaluate whether such a difference exists and whether it has statistical significance.

    For more details on the MEMS system, please see the description under the primary outcome.


  • Mean change in The Basel Assessment of Adherence to Tyrosine Kinase Inhibitors Scale (BAATIS) [ Time Frame: 1) Short term: 3 months prior to intervention until 6 months after starting the intervention; 2) Long term: 3 months prior to intervention until 18 months after starting the intervention ] [ Designated as safety issue: No ]

    Mean-difference in BAATIS scale scores between the run-in period and the intervention period (paired t-test)

    The BAATIS is a clinician reported outcome which has been used to assess adherence to immunosuppressive medication in solid organ transplant patients (BAASIS; Basal assessment of adherence with the Immunosuppressive Regimen Scale). Noens et al adapted the questionnaire for use among CML patients in the ADAGIO study. We have performed a similar adaptation

    Regarding time frames:

    Each questionnaire-related secondary outcome will be evaluated at two time frames:

    1. Short term, to assess an immediate effect on adherence
    2. Long term follow up (up to one year after the end of the intervention period) in order to determine whether the intervention has a long term effect on adherence.

  • Effect of intervention on tyrosine kinase inhibtor related adverse events [ Time Frame: 3 months prior to intervention until 6 months after starting the intervention ] [ Designated as safety issue: No ]
    The incidence of tyrosine kinase inhibitor related adverse events during 6 months of intervention compared to that witnessed during the initial 3 month run-in period

  • Adverse effects of tyrosine kinase inhibitors as a measure of MEMS-measured adherence [ Time Frame: 3 months prior to intervention until 3 months after starting the intervention ] [ Designated as safety issue: No ]
    The incidence of tyrosine kinase inhibtor related adverse events throughout the first 6 months of the study period as a function of adherence (measured by MEMS)

  • Percentage of patients improving in patient self-reported non-adherence [ Time Frame: 3 months prior to intervention until 6 months after starting the intervention ] [ Designated as safety issue: No ]

    The percentage of patients changing from a self-reported non-adherence of "yes" during the run-in period, to a self-reported non-adherence of "no" after the intervention, compared to the percentage of those who answered "yes" during the study period and remained "yes" after the intervention.

    Definition of the "Patient self-reported question regarding non-adherence":

    Each patient is asked the following question:

    "It is common that patients at times miss a few doses, for a whole range of reasons. Thinking of the past 7 days have you missed any doses?"

    If a patient answers 'yes' it will be taken as an indication that the patient has problems with adherence.


  • Mean change in the physician visual analogue scale (VAS) of adherence [ Time Frame: 1) Short term: 3 months prior to intervention until 6 months after starting the intervention; 2) Long term: 3 months prior to intervention until 18 months after starting the intervention ] [ Designated as safety issue: No ]

    Mean-difference in physician visual analogue scale (VAS) of adherence scores between the run-in period and the intervention period (paired t-test).

    The physician VAS on adherence rates patient adherence (as assessed by a physician) on a 10 cm VAS scale. A similar scale is in widespread use in several clinical disciplines, especially in assessing pain. It has also been used in assessing adherence to medication.

    The VAS ranges from perfect adherence (100% = 100mm) to no adherence (0% = 0mm).

    Regarding time frames:

    Each questionnaire-related secondary outcome will be evaluated at two time frames:

    1. Short term, to assess an immediate effect on adherence
    2. Long term follow up (up to one year after the end of the intervention period) in order to determine whether the intervention has a long term effect on adherence.

  • Mean change in the patient visual analogue scale (VAS) of adherence [ Time Frame: 1) Short term: 3 months prior to intervention until 6 months after starting the intervention; 2) Long term: 3 months prior to intervention until 18 months after starting the intervention ] [ Designated as safety issue: No ]

    Mean-difference in patient visual analogue scale (VAS) of adherence scores between the run-in period and the intervention period (paired t-test).

    The patient VAS on adherence rates patient adherence (as assessed by the patient) on a 10 cm VAS scale.

    See detailed explanation on the VAS under the outcome "Mean change in the physician visual analogue scale (VAS) of adherence"

    Regarding time frames:

    Each questionnaire-related secondary outcome will be evaluated at two time frames:

    1. Short term, to assess an immediate effect on adherence
    2. Long term follow up (up to one year after the end of the intervention period) in order to determine whether the intervention has a long term effect on adherence.


Estimated Enrollment: 88
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Run-in period
First 3 months of study during which adherence will be measured for each consecutively included study subject, but no intervention will be performed. Patient will receive routine treatment for CML according to the physician discretion.
Experimental: Adherence-encouraging period

Months 4 to 9 of study during which adherence will be measured for each consecutively included study subject, while implementing adherence-encouraging interventions:

  1. adherence-encouraging interventions - Group meetings
  2. adherence-encouraging interventions - Individual meetings
  3. adherence-encouraging interventions - Monthly phone calls

Patient will receive routine treatment for CML according to the physician discretion.

Behavioral: Adherence-encouraging interventions - Group meeting
One Group meeting (at the beginning of the intervention period) for all participants, focusing on issues relevant to adherence improvement
Behavioral: Adherence-encouraging interventions - Individual meetings
Individual meetings focusing on adherence issues with a multidiscilinary team
Behavioral: Adherence-encouraging interventions - Monthly phone calls
Monthly phone calls to detect urgent adherence-related issues

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic phase chronic myeloid leukemia (CP-CML), aged 18 years or older

    • CP-CML defined as: Medical history of cytogenetically confirmed CP-CML defined as the presence of the Philadelphia chromosome on bone marrow aspirates (a minimum of 20 metaphases is required; FISH cannot be used). If Philadelphia chromosome was negative or if cytogenetic results were not available, BCR-ABL-positive CML patients can be included.
  • At least 3 months of TKI treatment (imatinib, dasatinib or nilotinib) before study initiation.

Exclusion Criteria:

  • Current or prior accelerated/blast phase or stem cell transplant
  • Participation in another interventional study
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768689

Contacts
Contact: Pia Raanani, MD +972504065447 praanani@012.net.il
Contact: Avi Leader, MD +972544437212 avileader@yahoo.com

Locations
Israel
Soroka Medical Center Recruiting
Beer Sheba, Israel, 84101
Principal Investigator: Itai Levi, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Principal Investigator: Noam Benyamini, MD         
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Principal Investigator: Martin Ellis, MD         
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Principal Investigator: Pia Raanani, MD         
Sub-Investigator: Avi Leader, MD         
Sponsors and Collaborators
pia raanani
Investigators
Principal Investigator: Pia Raanani, MD Rabin Medical Center
  More Information

Publications:

Responsible Party: pia raanani, Prof. Pia Raanani, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01768689     History of Changes
Other Study ID Numbers: TAKE IT - CML adherence
Study First Received: January 8, 2013
Last Updated: July 3, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
adherence
chronic myeloid leukemia
tyrosine kinase inhibitors

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014