Interventional Study to Improve Adherence to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia

NCT01768689 | Completed

• 1 other identifier: TAKE IT - CML adherence
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Medication Adherence

Keywords

adherence; chronic myeloid leukemia; tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (2)

• Clinically relevant change in MEMS-measured adherence

  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

  From 3 months before intervention, until 3 months after starting the intervention

• General improvement in MEMS-measured adherence

  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.

  3 months prior to the intervention, until 3 months after starting the intervention

Secondary Outcomes (7)

• Mean-difference in MEMS-measured adherence

  3 months prior to intervention until 3 months after starting the intervention

• Mean change in The Basel Assessment of Adherence to Tyrosine Kinase Inhibitors Scale (BAATIS)

  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

• Effect of intervention on tyrosine kinase inhibtor related adverse events

  3 months prior to intervention until 6 months after starting the intervention

• Adverse effects of tyrosine kinase inhibitors as a measure of MEMS-measured adherence

  3 months prior to intervention until 3 months after starting the intervention

• Percentage of patients improving in patient self-reported non-adherence

  3 months prior to intervention until 6 months after starting the intervention

Study Arms (2)

Run-in period

NO INTERVENTION

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.

Adherence-encouraging period

EXPERIMENTAL

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; Behavioral: Adherence-encouraging interventions - Individual meetings; Behavioral: Adherence-encouraging interventions - Monthly phone calls

Interventions

Adherence-encouraging interventions - Group meeting BEHAVIORAL

One Group meeting (at the beginning of the intervention period) for all participants, focusing on issues relevant to adherence improvement

Adherence-encouraging period

Adherence-encouraging interventions - Individual meetings BEHAVIORAL

Individual meetings focusing on adherence issues with a multidiscilinary team

Adherence-encouraging period

Adherence-encouraging interventions - Monthly phone calls BEHAVIORAL

Monthly phone calls to detect urgent adherence-related issues

Adherence-encouraging period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current or prior accelerated/blast phase or stem cell transplant
• Participation in another interventional study
• Pregnancy

Sponsors & Collaborators

• pia raanani: lead

Study Sites (4)

Soroka Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Related Publications (7)

• Noens L, van Lierde MA, De Bock R, Verhoef G, Zachee P, Berneman Z, Martiat P, Mineur P, Van Eygen K, MacDonald K, De Geest S, Albrecht T, Abraham I. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood. 2009 May 28;113(22):5401-11. doi: 10.1182/blood-2008-12-196543. Epub 2009 Apr 6.

  PMID: 19349618 BACKGROUND

• Eliasson L, Clifford S, Barber N, Marin D. Exploring chronic myeloid leukemia patients' reasons for not adhering to the oral anticancer drug imatinib as prescribed. Leuk Res. 2011 May;35(5):626-30. doi: 10.1016/j.leukres.2010.10.017. Epub 2010 Nov 20.

  PMID: 21095002 BACKGROUND

• Gater A, Heron L, Abetz-Webb L, Coombs J, Simmons J, Guilhot F, Rea D. Adherence to oral tyrosine kinase inhibitor therapies in chronic myeloid leukemia. Leuk Res. 2012 Jul;36(7):817-25. doi: 10.1016/j.leukres.2012.01.021. Epub 2012 Feb 23.

  PMID: 22364811 BACKGROUND

• Marin D, Bazeos A, Mahon FX, Eliasson L, Milojkovic D, Bua M, Apperley JF, Szydlo R, Desai R, Kozlowski K, Paliompeis C, Latham V, Foroni L, Molimard M, Reid A, Rezvani K, de Lavallade H, Guallar C, Goldman J, Khorashad JS. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol. 2010 May 10;28(14):2381-8. doi: 10.1200/JCO.2009.26.3087. Epub 2010 Apr 12.

  PMID: 20385986 BACKGROUND

• Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

  PMID: 16079372 BACKGROUND

• Moon JH, Sohn SK, Kim SN, Park SY, Yoon SS, Kim IH, Kim HJ, Kim YK, Min YH, Cheong JW, Kim JS, Jung CW, Kim DH. Patient counseling program to improve the compliance to imatinib in chronic myeloid leukemia patients. Med Oncol. 2012 Jun;29(2):1179-85. doi: 10.1007/s12032-011-9926-8. Epub 2011 Apr 7.

  PMID: 21472487 BACKGROUND

• Jonsson S, Olsson B, Soderberg J, Wadenvik H. Good adherence to imatinib therapy among patients with chronic myeloid leukemia--a single-center observational study. Ann Hematol. 2012 May;91(5):679-685. doi: 10.1007/s00277-011-1359-0. Epub 2011 Nov 3.

  PMID: 22048790 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Medication Adherence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Pia Raanani, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The adherence assessed per study protocol was masked to participants and care providers during the preintervention and post intervention phases. At the time of intervention participants were notified once of their adherence as part of the feedback-based intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Pia Raanani

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 15, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)