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
Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
QoL (quality of life) scores at baseline - EORTC-QLQ-C30 — 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 at the end of treatment - EORTC-QLQ-C30 — 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 — 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 — 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 — 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)
QoL (quality of life) scores variations after 1 year from the start of therapy - FACT-Lym-LymS — 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)
Trial sites (21)
Facility
City
Region
Status
S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Alessandria
Recruiting
Clinica di Ematologia - A.O.U. Ospedali Riuniti
Ancona
Italy
Recruiting
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari
Italy
Recruiting
Ematologia - ASST Spedali Civili di Brescia
Brescia
Italy
Recruiting
Ematologia - Ospedale di Castelfranco Veneto
Castelfranco Veneto
Italy
Recruiting
U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco
Catania
Italy
Recruiting
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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