Clinical trial NCT03090477: Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients
Official title: Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients. A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Medication Adherence
Lead sponsor: UCSI University
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: Ampang Hospital, Malaysia
First posted: 2017-03-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in percentage of patients who adhere to prescribed TKI therapy
timeFrame: 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 outcomes:
measure: Changes in percentage of patients who achieve major/deep molecular response to TKI
timeFrame: 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
measure: Mean changes in health-related quality of life status
timeFrame: 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
Other outcomes:
Locations:
city: Ampang
country: Malaysia
facility: Ampang hospital
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
affiliation: UCSI University
name: Bee Kim Tan, RPh
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kekale 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.
citation: Tan BK, Chua SS, Chen LC, Chang KM, Balashanker S, Bee PC. Efficacy of a medication management service in improving adherence to tyrosine kinase inhibitors and clinical outcomes of patients with chronic myeloid leukaemia: a randomised controlled trial. Support Care Cancer. 2020 Jul;28(7):3237-3247. doi: 10.1007/s00520-019-05133-0. Epub 2019 Nov 16.