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Clinical Trials in Italy / NCT05934084
Recruiting Not applicable

Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

NCT05934084 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-02-26
Last updated
2026-09-11

Condition(s) studied

Classical Hodgkin LymphomaDiffuse Large B Cell Lymphoma (DLBCL)Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Investigational drug(s) / intervention(s)

Lifestyles Implemented-Survivorship Care Plan (LS-SCP)

Lifestyles Implemented-Survivorship Care Plan (LS-SCP): Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity) for 6 months. A bi-monthly automatic call to assess the compliance at the experimental arm (LS-SCP, Lifestyles implemented-Survivorship Care Plan) will be performed.

Study summary

This is a prospective randomized open-label, multicenter, 2-arm study to assess the role of healthy LifeStyle implemented Survivorship Care Plan (LS-SCP) in modifying the Quality of Life (QoL) in a population of long-term lymphoma survivors (in remission for a minimum 3 years since the last treatment and a maximum of 10 years).

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18-50 at initial treatment; * Diagnosis of classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL) or Primary mediastinal large B-cell lymphoma (PMBCL); * Patients in Complete Remission (CR) after first-line therapy \[ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, doxorubicin , cyclophosphamide, vincristine, procarbazine and prednisone) or ABVD-BEACOPP Pet-2 guided treatment for cHL; R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine and prednisone) for DLBCL; R-CHOP or R-DA-EPOCH (rituximab- Dose Adapted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) for PMBCL); * Patients in remission for a minimum 3 years since the last treatment and a maximum of 10 years; * Cumulative doxorubicin/ adriamycin dose received of at least 200 mg/mq (4 cycles of chemotherapy); * Availability echocardiogram (ECG) and 2D-STE-echocardiography (Two-dimensional speckle strain echocardiography) performed no later than three months prior to enrollment; * Signature of a written informed consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate voluntarily in the study. Exclusion Criteria: * Diagnosis of secondary cancer at baseline, except non-melanoma skin cancers and adequately treated cone-biopsied in situ carcinoma of the cervix; * Second line chemotherapy of stem cell transplant; * Not able to perform physical activity; * Grade \>/=3 neuropathy; * Vertebral fractures or stenosis of the vertebral canal; other bone fracture; * Cardiovascular disease: arrhythmia \>/= grade 2, hypertension \>/ grade 2, left ventricular dysfunction \>/= grade 2 pericardial disease/effusion any grade, myocarditis any grade, pulmonary hypertension any grade, restrictive cardiomyopathy any grade valvular hearth disease \>/= grade 2, right ventricular dysfunction \>/= grade 2; * Venous thromboembolism or arterial thrombosis during last 6 months; * Hemorrhage/ bleeding \>/= grade 2 during last 6 months; * Chronic lymphedema (arms and/ or limbs); * Rheumatic disease or inflammatory bowel disease in systemic treatment; * Any pleural effusion; * If female, the patient is pregnant; * Unwilling to comply to all required visits and procedures for the duration of study participation

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Ancona - AOU Ospedali Riuniti - Clinica di Ematologia Ancona Ancona Recruiting
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati Aviano Aviano Recruiting
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare Bari Bari Recruiting
Ospedale S. Martino - UOC Oncologia Belluno Belluno Recruiting
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia Barletta Italy Recruiting
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O. Bolzano Italy Recruiting
ASST Spedali Civili di Brescia - Ematologia Brescia Italy Recruiting
Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo Brindisi Italy Recruiting
PO Sant'Elia ASP Caltanisetta - UOC Ematologia Caltanissetta Italy Not Yet Recruiting
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia Catania Italy Recruiting
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia Catania Italy Recruiting
Ospedale Generale di zona Valduce - Oncoematologia Como Italy Recruiting
Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia Florence Italy Recruiting
Ospedale Vito Fazzi - Ematologia Lecce Italy Recruiting
ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano Legnano Italy Recruiting
AOU G. Martino - U.O.C. Ematologia Messina Italy Not Yet Recruiting
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia Milan Italy Recruiting
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia Milan Italy Recruiting
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia Milan Italy Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia Modena Italy Recruiting
AOU Maggiore della Caritа di Novara - SCDU Ematologia Novara Italy Recruiting
AOU di Padova - Ematologia Padova Italy Recruiting
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 Padova Italy Recruiting
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia Pagani Italy Recruiting
AOU Policlinico Giaccone - Ematologia Palermo Italy Recruiting
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi Pescara Italy Recruiting
Ospedale Guglielmo da Saliceto - U.O.Ematologia Piacenza Italy Recruiting
AOU G. Martino - U.O.C. Ematologia Pisa Italy Not Yet Recruiting
A.O.R. "San Carlo" - U.O. Ematologia Potenza Italy Not Yet Recruiting
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia Reggio Emilia Italy Recruiting
Ospedale degli Infermi di Rimini - U.O. di Ematologia Rimini Italy Recruiting
AO Sant'Andrea - Ematologia Roma Italy Recruiting
Ospedale S. Eugenio - UOC Ematologia Roma Italy Recruiting
Policlinico Tor Vergata - Ematologia Roma Italy Not Yet Recruiting
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare Roma Italy Recruiting
Istituto Clinico Humanitas - U.O. Ematologia Rozzano Italy Withdrawn
AOU di Sassari - Ematologia Sassari Italy Recruiting
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico Sassuolo Italy Recruiting
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria Torino Italy Recruiting
Ospedale Ca Foncello - S.C di Ematologia Treviso Italy Recruiting

More Fondazione Italiana Linfomi - ETS trials in Italy

Other trials for the same condition

Official registry record

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.

View NCT05934084 on ClinicalTrials.gov ↗ ← All trials in Italy