Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 464
- 试验地点
- 14
- 主要终点
- Quality of life measurement
研究概览
简要总结
The emergence of new anti-cancer drugs orally administered has revolutionized the prognosis and modalities of management of several lymphomas over the past decade. Today, half of patients receive oral therapy at home. Ibrutinib, acalabrutinib, idelalisib, venetoclax and lenalidomide are oral therapies used in the treatment of Chronic Lymphoid Leukemia, Follicular Lymphoma, Waldenström's disease and mantle cell lymphoma, in relapsing but soon to be 1st line.
Nevertheless, clinical trials leading to marketing authorizations for these drugs were performed in a small number of patients and very little data is available on their use in real life conditions. Their impact on the quality of life of patients also remains to be assessed.
The aim of this clinical research is to evaluate quality of life of patients at the initiation of the first oral therapy and every year for 5 years. This study will also identify factors (biological and non-biological: quality of life, shared decision-making ...) associated with a good response of patients and follow-up for the occurrence of long-term adverse reactions (5 years).
详细描述
Prospective longitudinal cohort. This observational study is monocentric. For each patient, data will be collected during 5 years.
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
- •Patients included in the PK-E3i clinical study OR
- •Over the age of 18
- •Patients with hemopathies and starting treatment with oral therapy (idelalisib, ibrutinib, venetoclax, lenalidomide, acalabrutinib...)
- •Be able to understand the objective and the constraints related to research
- •Patient having read the information notice and the non-objection form
- •Social Security affiliation
排除标准
- •Pregnant women
- •Persons under legal protection of adults
- •Patients under judicial protection
结局指标
主要结局
Quality of life measurement
时间窗: 5 years
Evaluation of the quality of life score, throught the quality of life scale (higher score associated with poor quality of life)
次要结局
- Evaluation of patients factors(5 years)
