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

U

UCSI University

Status

Completed

Conditions

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

Treatments

Behavioral: Pharmaceutical care and adherence aids

Study type

Interventional

Funder types

Other

Identifiers

NCT03090477
NMRR23315

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

129 participants in 2 patient groups

Pharmaceutical care and adherence aids
Experimental group
Treatment:
Behavioral: Pharmaceutical care and adherence aids
Control (dispensing of TKI & instruction about administration)
No Intervention group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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