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

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ClinicalTrials.gov Identifier: NCT03090477
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
University of Malaya
Ampang Hospital, Malaysia
Information provided by (Responsible Party):
Bee kim Tan, UCSI University

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.

Condition or disease Intervention/treatment Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Medication Adherence Behavioral: Pharmaceutical care and adherence aids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients. A Randomised Control Trial
Actual Study Start Date : March 24, 2017
Actual Primary Completion Date : June 24, 2018
Actual Study Completion Date : January 31, 2019


Arm Intervention/treatment
Experimental: Pharmaceutical care and adherence aids 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.

No Intervention: Control (dispensing of TKI & instruction about administration)



Primary Outcome Measures :
  1. Changes in percentage of patients who adhere to prescribed TKI therapy [ 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 ]
    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


Secondary Outcome Measures :
  1. Changes in percentage of patients who achieve major/deep molecular response to TKI [ 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 ]
    Molecular response is determined as log-reduction of BCR-ABL1 mRNA by polymerase chain reaction (PCR) in international scale (IS)

  2. Mean changes in health-related quality of life status [ 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 ]
    HRQoL is determined as patient-reported score on EORTC QLQ-C30 and CML24 questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090477


Locations
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Malaysia
Ampang hospital
Ampang, Selangor, Malaysia, 68000
University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
Sponsors and Collaborators
UCSI University
University of Malaya
Ampang Hospital, Malaysia
Investigators
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Principal Investigator: Bee Kim Tan, RPh UCSI University

Publications:

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Responsible Party: Bee kim Tan, Lecturer, UCSI University
ClinicalTrials.gov Identifier: NCT03090477     History of Changes
Other Study ID Numbers: NMRR23315
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases