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NCT Number: NCT06229860

Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts w/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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Chronic Phase Chronic Myelogenous Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Mahtab Jafari, Pharm.D

CONTACT

[email protected]

877-827-8839

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

In-person interview with the study coordinator to complete study questionnaire.

Primary outcomes

  1. 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

  2. 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"

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myeloid Leukemia

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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