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

ClinicalTrials.gov ID

NCT05524298

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

150Estimated

Last Update Posted

Sep 11, 2026Actual

Start Date

Dec 7, 2022Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

Official Title

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

Brief Summary

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

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).

• Low Grade Non-Hodgkin's Lymphoma, Adult

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

fabbri7@unisi.it

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