- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06229860
Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts w/Chronic Myeloid Leukemia
March 6, 2026 updated by: Mahtab Jafari, University of California, Irvine
Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myeloid Leukemia
This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The purpose of this pilot study is to explore the association between personality and adherence to a specific type of oral cancer medication - tyrosine kinase inhibitor (TKI) - in patients with chronic myeloid leukemia (CML).
75 individuals with chronic phase CML who are being treated with TKIs will be recruited.
Consenting patients will participate in a focused interview where TKI adherence, personality type, and quality of life and symptom burden will be assessed using validated questionnaires.
Information on treatment response and the treating physician's perception of TKI adherence will be obtained from the electronic health record.
Study Type
Observational
Enrollment (Estimated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chao Family Comprehensive Cancer Center University of California, Irvine
- Phone Number: 1-877-827-8839
- Email: ucstudy@uci.edu
Study Contact Backup
- Name: University of California Irvine Medical
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Recruiting
- Chao Family Comprehensive Cancer Center University of California, Irvine
-
Contact:
- Mahtab Jafari, Pharm.D
- Phone Number: 877-827-8839
- Email: ucstudy@uci.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study populations include adult patients with CML in chronic phase (CML-CP) who are being treated with one of the four TKIs - imatinib, dasatinib, bosutinib, and nilotinib
Description
Inclusion Criteria:
- 18 years of age or older
- Diagnosed with chronic myeloid leukemia (CML) and in the chronic phase (CML-CP)
- Currently being treated with one of four cancer medications - imatinib, dasatinib, bosutinib, or nilotinib
- A patient at the UCI Chao Family Comprehensive Cancer Center (CFCCC), or
- A member of a patient support group organized by the CML Buster Foundation
- Do not meet any of the criteria listed under "Exclusion Requirements"
Exclusion Criteria:
- Unable to read and speak English
- Impaired decisional capacity to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult patients with CML in chronic phase (CML-CP)
|
In-person interview with the study coordinator to complete study questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of adherence to TKI medication
Time Frame: Up to 1 year
|
This will be measured by Morisky Medication Adherence Scale (MMAS), an 8-item tool related to adherence behavior include forgetfulness, stopping medication because of worsening of symptoms or improvement in health condition, and inconvenience of continuing medication.
Each item is scored 0 or 1 depending on whether the patient answers yes or no, with a minimum score of 0 and maximum score of 8
|
Up to 1 year
|
|
Personality assessment
Time Frame: Up to 1 year
|
Patient personality will be assessed using the Mini International Personality Item Pool (mini-IPIP) questionnaire.
In the mini-IPIP, each of the five factors (openness, conscientiousness, extraversion, agreeableness and neuroticism) is assessed with four items, making a total of 20 items.
Each item is scored on a scale of 1 through 5, with 1 indicating "very inaccurate" and 5 corresponding to "very accurate"
|
Up to 1 year
|
|
Assessment of quality of Life
Time Frame: Up to 1 year
|
This will be measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30).
EORTC QLQ C30 includes 30 items that measure global health status, functioning, and symptoms.
|
Up to 1 year
|
|
Assessment of quality of Life and symptom burden
Time Frame: Up to 1 year
|
This will be measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia -24 scales.(EROTC
QLQ-CML 24).
The EORTC QLQ CML 24 is a 24-item questionnaire developed exclusively to assess QoL issues in patients with CML
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mahtab Jafari, Pharm.D, Chao Family Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2024
Primary Completion (Actual)
March 19, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
January 17, 2024
First Submitted That Met QC Criteria
January 26, 2024
First Posted (Actual)
January 29, 2024
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 6, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Chronic Disease
- Disease Attributes
- Neoplasms by Histologic Type
- Hematologic Diseases
- Leukemia, Myeloid
- Bone Marrow Diseases
- Leukemia
- Myeloproliferative Disorders
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
Other Study ID Numbers
- 3709
- UCI 23-110 (Other Identifier: UCI CFCCC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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