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

NCT03090477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2019-04-05

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Malaya

    collaborator OTHER

  • Ampang Hospital, Malaysia

    collaborator UNKNOWN

  • UCSI University

    lead OTHER

Principal Investigators

  • Bee Kim Tan, RPh · UCSI University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-24
Primary Completion
2018-06-24
Completion
2019-01-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090477 on ClinicalTrials.gov