Chronic Myeloid LeukemiaNCT06229860
Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts w/Chronic Myeloid Leukemia
An observational study of Chronic Myeloid Leukemia and Chronic Phase Chronic Myelogenous Leukemia, run by University of California, Irvine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase Chronic Myelogenous Leukemia
- What is being tested?
- Interview
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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
Who may be able to join
- 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"
Who cannot join
- Unable to read and speak English
- Impaired decisional capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
Mahtab Jafari, Pharm.D, 877-827-8839, ucstudy@uci.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Interview
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
In-person interview with the study coordinator to complete study questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with CML in chronic phase (CML-CP) | Not described Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adherence to TKI medication
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
Measured: Up to 1 year
Personality assessment
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"
Measured: Up to 1 year
Assessment of quality of Life
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.
Measured: Up to 1 year
Assessment of quality of Life and symptom burden
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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start25 Jan 2024
- Primary completion19 Mar 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahtab Jafari, University of California, Irvine
- Investigators
- Mahtab Jafari, Pharm.D, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229860
- Sponsor's protocol ID
- 3709
- Other IDs
- UCI 23-110
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06229860
- Acronym / sponsor ID
- 3709
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with CML in chronic phase (CML-CP) | – | Other: Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to read and speak English
- Impaired decisional capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewIn-person interview with the study coordinator to complete study questionnaire. | Other | Adult patients with CML in chronic phase (CML-CP) |
Primary outcome
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
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"
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Mahtab Jafari, Pharm.D principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia and Chronic Phase Chronic Myelogenous Leukemia, run by University of California, Irvine at 1 site in United States.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adherence to TKI medication (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.