Clinical trial NCT05524298: Quality of Life on Elderly Patients with Low Grade Non-Hodgkin Lymphoma
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Grade Non-Hodgkin's Lymphoma, Adult
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy.

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).

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

Primary outcomes:
measure: QoL (quality of life) scores at baseline - EORTC-QLQ-C30
timeFrame: The endpoint wil be evaluated at the baseline.
measure: QoL (quality of life) scores variations at the end of treatment - EORTC-QLQ-C30
timeFrame: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)
measure: QoL (quality of life) scores variations after 1 year from the start of therapy - EORTC-QLQ-C30
timeFrame: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)
measure: QoL (quality of life) scores at baseline - FACT-Lym-LymS
timeFrame: The endpoint wil be evaluated at the baseline.
measure: QoL (quality of life) scores variations at the end of treatment - FACT-Lym-LymS
timeFrame: The endpoint will be evaluated from the beginning of the study to the end of therapy (up to 18 months)
measure: QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS
timeFrame: The endpoint will be evaluated after 1 year from the start of therapy (up to 30 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
measure: Progression-Free Survival (PFS)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
measure: Event-Free Survival (EFS)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
measure: Overall Response Rate (ORR)
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
measure: Registration of safety
timeFrame: The endpoint will be evaluated from the beginning to the end of the study (up to 30 months)
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Clinica di Ematologia - A.O.U. Ospedali Riuniti
city: Aviano
country: Italy
facility: Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
city: Bari
country: Italy
facility: U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
city: Brescia
country: Italy
facility: Ematologia - ASST Spedali Civili di Brescia
city: Castelfranco Veneto
country: Italy
facility: Ematologia - Ospedale di Castelfranco Veneto
city: Catania
country: Italy
facility: U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco
city: Firenze
country: Italy
facility: Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
city: Messina
country: Italy
facility: S.C. Ematologia - Azienda Ospedali Riuniti Papardo-Piemonte
city: Milano
country: Italy
facility: Unitа Linfomi - Dipartimento Oncoematologia, Istituto Scientifico San Raffaele
city: Milano
country: Italy
facility: S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda
city: Palermo
country: Italy
facility: Ematologia - A.O.U. Policlinico Giaccone
city: Palermo
country: Italy
facility: Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
city: Piacenza
country: Italy
facility: U.O. Ematologia - Ospedale Guglielmo da Saliceto
city: Reggio Emilia
country: Italy
facility: Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
city: Rimini
country: Italy
facility: U.O. di Ematologia - Ospedale degli Infermi di Rimini
city: Roma
country: Italy
facility: Ematologia,Trapianto cellule staminali, Medicina Trasfusionale e Terapia cellulare -Policlinico Universitario Campus Bio-Medico
city: Siena
country: Italy
facility: U.O.C. Ematologia - A.O.U. Senese
city: Varese
country: Italy
facility: U.O.C. Ematologia - Ospedale di Circolo
Study officials:
affiliation: Ematologia - A.O.U. Policlinico Giaccone, Palermo
name: Salvatrice Mancuso
role: PRINCIPAL_INVESTIGATOR
References: