Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts W/Chronic Myeloid Leukemia

Recruiting

• Conditions: Chronic Phase Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia
• Interventions: Other: Interview

• Registration Number: NCT06229860
• Lead Sponsor: University of California, Irvine

Brief 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.

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 Timeline

• Study First Submitted: 2024-01-17
• Study Start: 2024-01-25
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with CML in chronic phase (CML-CP)	Interview	-

Primary Outcome Measures

Name	Time	Method
Assessment of quality of Life	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.
Personality assessment	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 and symptom burden	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
Assessment of adherence to TKI medication	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

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center University of California, Irvine; 🇺🇸 Orange, California, United States