Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients

Medication Adherence Clinical Trial

Official title:

Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients. A Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090477
• Other study ID #: NMRR23315
• Status: Completed
• Phase: N/A
• Start date: March 24, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2019
• Source: UCSI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Owing to effective treatment with tyrosine kinase inhibitors (TKIs), chronic myeloid leukemia (CML) has become a chronic disease with a rising prevalence globally. Although the possibility of stopping TKI therapy in CML patients who have achieved deep molecular responses is a topic of active debate and investigation, life-long treatment remains the current standard of care. It has been estimated that 3% to 56% of CML patients are not adherent to their prescribed TKI therapy. Poor adherence to TKIs could compromise the control of CML, and contributes to poorer survival. CML patients on long-term TKI therapy are prone to developing certain medication-related issues such as adverse reactions and drug interactions.Occurrence of adverse reactions even at low grades, has been shown to impact CML patient's health-related quality of life (HRQoL) and adherence to treatment. However, there is no prospective high quality evidence showing adherence to TKIs and the associated clinical outcomes can be improved in CML patients. Therefore, the investigators hypothesize that medication management intervention by pharmacist might improve adherence to TKIs, and translate into better disease response and HRQoL in CML patients, when compared to control arm who receive standard pharmacy service.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 31, 2019
• Est. primary completion date: June 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• has a confirmed diagnosis of Philadelphia chromosome positive CML

• has a detectable BCR-ABL1 mRNA

• has been taking TKI for at least 3 months

• able to speak and read English, Malay or Mandarin

Exclusion Criteria:

• with cognitive deficit or psychiatric disorders

• in advanced phase of CML where TKI is transitory to hematologic stem cell transplant

• history of hematologic stem cell transplant

• pregnant or plan to conceive in the next 1 year

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Medication Adherence

Intervention

Behavioral:
• Pharmaceutical care and adherence aids
Medication review including drug-interaction check, individual patient counseling to improve understanding of treatment rationale and to elicit and address treatment-related concerns, provision of information booklets and adherence aids (calender blister packaging and smartphone medication reminder application), phone calls and face-to-face visits to follow-up on medication-related issues scheduled over a period of 6 months.

Locations

Country	Name	City	State
Malaysia	Ampang hospital	Ampang	Selangor
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan

Sponsors (3)

Lead Sponsor	Collaborator
UCSI University	Ampang Hospital, Malaysia, University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

Kekäle M, Peltoniemi M, Airaksinen M. Patient-reported adverse drug reactions and their influence on adherence and quality of life of chronic myeloid leukemia patients on per oral tyrosine kinase inhibitor treatment. Patient Prefer Adherence. 2015 Dec 8;9:1733-40. doi: 10.2147/PPA.S92125. eCollection 2015. — View Citation

Lam MS, Cheung N. Impact of oncology pharmacist-managed oral anticancer therapy in patients with chronic myelogenous leukemia. J Oncol Pharm Pract. 2016 Dec;22(6):741-748. Epub 2015 Sep 28. — View Citation

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. — View Citation

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. — View Citation

Noens L, Hensen M, Kucmin-Bemelmans I, Lofgren C, Gilloteau I, Vrijens B. Measurement of adherence to BCR-ABL inhibitor therapy in chronic myeloid leukemia: current situation and future challenges. Haematologica. 2014 Mar;99(3):437-47. doi: 10.3324/haematol.2012.082511. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in percentage of patients who adhere to prescribed TKI therapy	Adherence is defined as having an medication possession ratio (MPR) of greater than 90% (calculated as days' supply of TKI dispensed divided by number of days of the study period) from electronic prescription refill database system	Evaluated at 2 time frame, (a) Immediate effect of intervention: 1-3 months pre-intervention until 6 months after starting intervention; (b) long-term effect of intervention: 1-3 months pre-intervention until 6 months after the end of intervention
Secondary	Changes in percentage of patients who achieve major/deep molecular response to TKI	Molecular response is determined as log-reduction of BCR-ABL1 mRNA by polymerase chain reaction (PCR) in international scale (IS)	Evaluated at 2 time frame, (a) 0-3 months pre-intervention until 6 months after starting intervention; (b) 0-3 months pre-intervention until 6 months after the end of intervention
Secondary	Mean changes in health-related quality of life status	HRQoL is determined as patient-reported score on EORTC QLQ-C30 and CML24 questionnaire	Evaluated at 2 time frame, (a) 1 week pre-intervention until 6 months after starting intervention; (b) 1 week pre-intervention until 6 months after the end of intervention