Quality of Life on Elderly Patients with Low Grade Non-Hodgkin Lymphoma

Last updated: December 30, 2024
Sponsor: Fondazione Italiana Linfomi - ETS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT05524298
FIL_QoL-ELDIND
  • Ages > 70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Local histological diagnosis of indolent B cell non-Hodgkin lymphoma: follicularlymphoma, 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 aninformed consent form approved by an IEC (Independent Ethics Committee), prior toregistration into the study

Note: Patient treated in the context of a clinical trial is admitted

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 150
Study Start date:
December 07, 2022
Estimated Completion Date:
February 28, 2025

Study 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).

Connect with a study center

  • S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121
    Italy

    Active - Recruiting

  • Clinica di Ematologia - A.O.U. Ospedali Riuniti

    Ancona, 60126
    Italy

    Active - Recruiting

  • Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano

    Aviano, 33081
    Italy

    Active - Recruiting

  • U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124
    Italy

    Active - Recruiting

  • Ematologia - ASST Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Ematologia - Ospedale di Castelfranco Veneto

    Castelfranco Veneto, 31033
    Italy

    Active - Recruiting

  • U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco

    Catania, 95123
    Italy

    Active - Recruiting

  • Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi

    Firenze, 50141
    Italy

    Active - Recruiting

  • S.C. Ematologia - Azienda Ospedali Riuniti Papardo-Piemonte

    Messina, 98158
    Italy

    Site Not Available

  • S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Active - Recruiting

  • Unitа Linfomi - Dipartimento Oncoematologia, Istituto Scientifico San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Ematologia - A.O.U. Policlinico Giaccone

    Palermo, 90127
    Italy

    Active - Recruiting

  • U.O. Ematologia - Ospedale Guglielmo da Saliceto

    Piacenza, 29121
    Italy

    Active - Recruiting

  • Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123
    Italy

    Active - Recruiting

  • U.O. di Ematologia - Ospedale degli Infermi di Rimini

    Rimini, 47923
    Italy

    Active - Recruiting

  • Ematologia,Trapianto cellule staminali, Medicina Trasfusionale e Terapia cellulare -Policlinico Universitario Campus Bio-Medico

    Roma, 00128
    Italy

    Active - Recruiting

  • U.O.C. Ematologia - A.O.U. Senese

    Siena, 53100
    Italy

    Active - Recruiting

  • U.O.C. Ematologia - Ospedale di Circolo

    Varese, 21100
    Italy

    Active - Recruiting

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