Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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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

Conditions
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Low Grade Non-Hodgkin's Lymphoma, Adult

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly Patients With Low Grade Non-Hodgkin Lymphoma<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL (quality of life) scores at baseline - EORTC-QLQ-C30 | 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) | The endpoint wil be evaluated at the baseline. | 
| QoL (quality of life) scores variations at the end of treatment - EORTC-QLQ-C30 | Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) | The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months) | 
| QoL (quality of life) scores variations after 1 year from the start of therapy - EORTC-QLQ-C30 | 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) | The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months) | 
| QoL (quality of life) scores at baseline - FACT-Lym-LymS | Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms) | The endpoint wil be evaluated at the baseline. | 
| QoL (quality of life) scores variations at the end of treatment - FACT-Lym-LymS | Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire) | The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months) | 
| QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS | Quality of life is measured with FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire) | The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival, the percentage of patients alive, is defined as the time between the date of registration and the date of death from any cause. | The endpoint will be evaluated from the beginning to the end of the study (up to 30 months) | 
| Progression-Free Survival (PFS) | Progression-Free Survival is defined as the time between the date of registration and the date of disease progression, relapse or death from any cause. | The endpoint will be evaluated from the beginning to the end of the study (up to 30 months) | 
| Event-Free Survival (EFS) | Event-Free Survival is defined as the time from start of treatment to disease progression, death or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without document progression. | The endpoint will be evaluated from the beginning to the end of the study (up to 30 months) | 
| Overall Response Rate (ORR) | Overall response rate is defined as the proportion of patients who have a complete response (CR), or partial response (PR) or stable disease (SD) to therapy.Overall Response Rate (ORR) will be defined according to the Lugano 2014 criteria. | The endpoint will be evaluated from the beginning to the end of the study (up to 30 months) | 
| Registration of safety | Safety is defined as incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), current version. | The endpoint will be evaluated from the beginning to the end of the study (up to 30 months) |