Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Assessment of quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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"
排除标准
- •Unable to read and speak English
- •Impaired decisional capacity to consent
研究组 & 干预措施
Adult patients with CML in chronic phase (CML-CP)
干预措施: Interview (Other)
结局指标
主要结局
Assessment of quality of Life
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Mahtab Jafari
Professor of Pharmaceutical Sciences & Equity Advisor
University of California, Irvine