Predictors of Health-Related Quality of Life in Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Health Related Quality of Life (HRQOL)
研究概览
简要总结
The study aims to improve our understanding of how quality of life, fatigue, and symptoms change over 2 years when participants are treated for chronic lymphocytic leukemia or small lymphocytic lymphoma. We will compare two types of treatment to help future patients with chronic lymphocytic leukemia or small lymphocytic lymphoma know what to anticipate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •All patients with pathology-confirmed diagnoses of CLL who are within seven days of starting treatment with a BTKi +/- an anti-CD 20 monoclonal antibody or BCL2i with Obinutuzumab treatment will be included.
- •Subjects must be able to read and speak English or Spanish at the 8th grade level.
排除标准
- •Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.
研究组 & 干预措施
Bruton's tyrosine kinase inhibitor treatment
Patients treated with a Bruton's tyrosine kinase inhibitor.
干预措施: Bruton's tyrosine kinase inhibitor (Drug)
B-Cell Lymphoma 2 Protein Inhibitor treatment
Patients treated with a B-Cell Lymphoma 2 Protein Inhibitor.
干预措施: B-Cell Lymphoma 2 Protein Inhibitor (Drug)
结局指标
主要结局
Health Related Quality of Life (HRQOL)
时间窗: Up to 2 years
Compare the differences in HRQOL scores measured by the Functional Assessment of Cancer Therapy Leukemia version for patients receiving BTKi, and BCL2i within 7 days of beginning treatment and at days 30,60, 90, 180, 1 year, 1.5 years, and 2 years following initiation of treatment.
HRQOL predictors
时间窗: Up to 2 years
Investigators will test how age, comorbidity, fatigue, symptoms, and disease characteristics are related to the slope of HRQOL in separate models.
Interactions with treatment
时间窗: Up to 2 years
Three models will assess interactions between treatment and age, comorbidity, and fatigue.
次要结局
未报告次要终点