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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229860
• Other study ID #: 3709
• Secondary ID: UCI 23-110
• Status: Recruiting
• Start date: January 25, 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 1-877-827-8839
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Chronic Phase Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Other:
• Interview
In-person interview with the study coordinator to complete study questionnaire.

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 1 year
Primary	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"	Up to 1 year
Primary	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.	Up to 1 year
Primary	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	Up to 1 year