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Leukemia, Myelogenous, Chronic, BCR-ABL PositiveNCT03090477

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

A study testing Pharmaceutical care and adherence aids in people with Leukemia, Myelogenous, Chronic, BCR-ABL Positive and Medication Adherence, run by UCSI University at 2 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pharmaceutical care and adherence aids
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
2 sitesMalaysia
Study dates
24 Mar 2017to 31 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Malaysia2 sites

  • Ampang hospital

    Ampang, Selangor, 68000

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 50603

Other trials in Malaysia

About this study

Official title: Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients. A Randomised Control Trial

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.

Being tested
Pharmaceutical care and adherence aids
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmaceutical care and adherence aidsBehavioural

    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.

Study groups in NCT03090477
Study groupRoleWhat they receive
Pharmaceutical care and adherence aidsExperimentalNot described
Receives: Behavioral: Pharmaceutical care and adherence aids
Control (dispensing of TKI & instruction about administration)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

Secondary outcomes (2)

  1. 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)

    Measured: 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

  2. Mean changes in health-related quality of life status

    HRQoL is determined as patient-reported score on EORTC QLQ-C30 and CML24 questionnaire

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start24 Mar 2017
  3. Primary completion24 Jun 2018
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03090477
Sponsor's protocol ID
NMRR23315
Status last verified
Apr 2019
First submitted
18 Mar 2017
Last updated
5 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marin D, Bazeos A, Mahon FX, Eliasson L, Milojkovic D, Bua M, Apperley JF, Szydlo R, Desai R, Kozlowski K, Paliompeis C, Latham V, Foroni L, Molimard M, Reid A, Rezvani K, de Lavallade H, Guallar C, Goldman J, Khorashad JS. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol. 2010 May 10;28(14):2381-8. doi: 10.1200/JCO.2009.26.3087. Epub 2010 Apr 12.

    PubMed 20385986

  • Lam MS, Cheung N. Impact of oncology pharmacist-managed oral anticancer therapy in patients with chronic myelogenous leukemia. J Oncol Pharm Pract. 2016 Dec;22(6):741-748. doi: 10.1177/1078155215608523. Epub 2015 Sep 28.

    PubMed 26419691

  • Noens L, Hensen M, Kucmin-Bemelmans I, Lofgren C, Gilloteau I, Vrijens B. Measurement of adherence to BCR-ABL inhibitor therapy in chronic myeloid leukemia: current situation and future challenges. Haematologica. 2014 Mar;99(3):437-47. doi: 10.3324/haematol.2012.082511.

    PubMed 24598855

  • Moon JH, Sohn SK, Kim SN, Park SY, Yoon SS, Kim IH, Kim HJ, Kim YK, Min YH, Cheong JW, Kim JS, Jung CW, Kim DH. Patient counseling program to improve the compliance to imatinib in chronic myeloid leukemia patients. Med Oncol. 2012 Jun;29(2):1179-85. doi: 10.1007/s12032-011-9926-8. Epub 2011 Apr 7.

    PubMed 21472487

  • Kekale M, Peltoniemi M, Airaksinen M. Patient-reported adverse drug reactions and their influence on adherence and quality of life of chronic myeloid leukemia patients on per oral tyrosine kinase inhibitor treatment. Patient Prefer Adherence. 2015 Dec 8;9:1733-40. doi: 10.2147/PPA.S92125. eCollection 2015.

    PubMed 26677317

  • Tan BK, Chua SS, Chen LC, Chang KM, Balashanker S, Bee PC. Efficacy of a medication management service in improving adherence to tyrosine kinase inhibitors and clinical outcomes of patients with chronic myeloid leukaemia: a randomised controlled trial. Support Care Cancer. 2020 Jul;28(7):3237-3247. doi: 10.1007/s00520-019-05133-0. Epub 2019 Nov 16.

    PubMed 31734798

Questions about this trial

What is this clinical trial studying?

A study testing Pharmaceutical care and adherence aids in people with Leukemia, Myelogenous, Chronic, BCR-ABL Positive and Medication Adherence, run by UCSI University at 2 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03090477, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.

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