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

NCT06229860 | Recruiting

• 2 other identifiers: 3709UCI 23-110
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Phase Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Adult patients with CML in chronic phase (CML-CP)

Other: Interview

Interventions

Interview OTHER

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

Adult patients with CML in chronic phase (CML-CP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Unable to read and speak English
• Impaired decisional capacity to consent

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mahtab Jafari, Pharm.D

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmaceutical Sciences & Equity Advisor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 29, 2024
• Study Start: January 25, 2024
• Primary Completion: March 19, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)