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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy

NCT00387647

Leukemia

COMPLETED PHASE2

Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment

NCT03573596

CML, Relapsed

UNKNOWN PHASE2

Investigating the Prevalence and Prognostic Importance of Polypharmacy in Adults Treated for Newly Diagnosed Acute Myelogenous Leukemia (AML)

NCT02662920

ACUTE MYELOGENOUS LEUKEMIA

COMPLETED

2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients

NCT02917720

Chronic Myeloid Leukemia

ACTIVE_NOT_RECRUITING PHASE2

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

NCT04079296

Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pharmaceutical care and adherence aids

Group Type EXPERIMENTAL

Pharmaceutical care and adherence aids

Intervention Type BEHAVIORAL

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.

Control (dispensing of TKI & instruction about administration)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No