Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi
概览
- 阶段
- 不适用
- 干预措施
- Elderly Patients With Low Grade Non-Hodgkin Lymphoma
- 疾病 / 适应症
- Low Grade Non-Hodgkin's Lymphoma, Adult
- 发起方
- Fondazione Italiana Linfomi - ETS
- 入组人数
- 150
- 试验地点
- 22
- 主要终点
- QoL (quality of life) scores at baseline - EORTC-QLQ-C30
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
Aims of this study are to describe the variation of QoL (Quality of Life) during the clinical management of low-grade lymphoma in elderly subjects and to identify the most important factors at diagnosis and during treatment with an impact on QoL (Quality of Life).
详细描述
This is a prospective, multicenter, non-interventional study aiming at investigating on the changes in QoL (Quality of Life) during the clinical management of low-grade lymphoma in elderly subjects and to possibly identify the most important factors at diagnosis and during treatment with an impact on QoL (Quality of Life). The study plans to enroll 150 patients with a local histologically confirmed diagnosis of indolent non-Hodgkin lymphoma fulfilling all the inclusion/exclusion criteria who provide written informed consent will be included in the study. Any type of treatment is allowed by the study (immunotherapy, immunochemotherapy at full or reduced dose, radiotherapy). All patients must undergo Comprehensive Geriatric Assessment (CGA) before starting any protocol treatment. Baseline, post-treatment and follow-up instrumental assessments and response evaluation is done as part of the routine clinical management for patients with indolent NHL (Non Hodgkin Lymphoma) . Response evaluation and all other assessments planned for the EOT (end of treatment) should be planned also in case of early withdrawal, according to clinical practice. HRQoL (Health-related Quality of Life) evaluation will be done at time of informed consent form signature prior to treatment start, at the end of the treatment (ranging from 1 month to 6 months according to the duration of the treatment) and after 1 year from the start of the therapy. QoL (quality of life) assessment includes all scales of the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire-Core 30) and the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma - lymphoma-specific symptoms questionnaire).
研究者
入排标准
入选标准
- •Local histological diagnosis of indolent B cell non-Hodgkin lymphoma: follicular lymphoma, marginal zone lymphoma (nodal, MALT (Mucosa-Associated Lymphoid Tissue), splenic), lymphoplasmacytic lymphoma/ Waldenström macroglobulinemia)
- •Age ≥ 70 years
- •Patient candidates to receive treatment for lymphoma
- •Patient previously untreated for lymphoma
- •Evaluation of Comprehensive Geriatric Assessment at baseline
- •Ability to provide informed consent: subject understands and voluntarily signs an informed consent form approved by an IEC (Independent Ethics Committee), prior to registration into the study
- •Note: Patient treated in the context of a clinical trial is admitted
排除标准
- 未提供
研究组 & 干预措施
Elderly Patients With Low Grade Non-Hodgkin Lymphoma
Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy. Assess QoL (quality of life) at baseline, at the end of treatment and after 1 year from the start of the therapy.
结局指标
主要结局
QoL (quality of life) scores at baseline - EORTC-QLQ-C30
时间窗: The endpoint wil be evaluated at the baseline.
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) questionnaire)
QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS
时间窗: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)
Quality of life is measured with FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
QoL (quality of life) scores variations at the end of treatment - EORTC-QLQ-C30
时间窗: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30)
QoL (quality of life) scores variations after 1 year from the start of therapy - EORTC-QLQ-C30
时间窗: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) and FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
QoL (quality of life) scores at baseline - FACT-Lym-LymS
时间窗: The endpoint wil be evaluated at the baseline.
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms)
QoL (quality of life) scores variations at the end of treatment - FACT-Lym-LymS
时间窗: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
次要结局
- Progression-Free Survival (PFS)(The endpoint will be evaluated from the beginning to the end of the study (up to 30 months))
- Event-Free Survival (EFS)(The endpoint will be evaluated from the beginning to the end of the study (up to 30 months))
- Overall Response Rate (ORR)(The endpoint will be evaluated from the beginning to the end of the study (up to 30 months))
- Registration of safety(The endpoint will be evaluated from the beginning to the end of the study (up to 30 months))
- Overall Survival (OS)(The endpoint will be evaluated from the beginning to the end of the study (up to 30 months))