An interventional study of Pharmaceutical care and adherence aids in Leukemia, Myelogenous, Chronic, BCR-ABL Positive and Medication Adherence, sponsored by UCSI University. Completed at 2 sites in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by UCSI University · Not applicable, Interventional, and Health services research
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.
982 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's enrollment of 129 is above the median of 43 across 755 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →UCSI University is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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
Time frame: 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
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)
Time frame: 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
Mean changes in health-related quality of life status
HRQoL is determined as patient-reported score on EORTC QLQ-C30 and CML24 questionnaire
Time frame: 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
Plan to share: No
Ran from Mar 2017 to primary completion in Jun 2018, 15 months.
Of 29 interventional studies with no phase under Leukemia, Myelogenous, Chronic, BCR-ABL Positive, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 123. This study's 15 months is below that.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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UCSI University