Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors
NCT ID: NCT05934084
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
552 participants
INTERVENTIONAL
2024-02-26
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control Arm (C)
Patients in the control arm will not receive any Survivorship Care Plan (SCP) or intervention and will be followed-up according to the best clinical practice, with questionnaires self-administration at 6 and 12 months from randomization.
No interventions assigned to this group
Experimental Arm (E)
Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Carla Minoia, MD
Role: PRINCIPAL_INVESTIGATOR
Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Locations
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Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Ancona, Italy
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Aviano, Italy
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari, Bari, Italy
Ospedale S. Martino - UOC Oncologia
Belluno, Belluno, Italy
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, , Italy
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
Bolzano, , Italy
ASST Spedali Civili di Brescia - Ematologia
Brescia, , Italy
Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
Brindisi, , Italy
PO Sant'Elia ASP Caltanisetta - UOC Ematologia
Caltanissetta, , Italy
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania, , Italy
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Catania, , Italy
Ospedale Generale di zona Valduce - Oncoematologia
Como, , Italy
Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
Florence, , Italy
Ospedale Vito Fazzi - Ematologia
Lecce, , Italy
ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
Legnano, , Italy
AOU G. Martino - U.O.C. Ematologia
Messina, , Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, , Italy
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
Milan, , Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
Milan, , Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
Modena, , Italy
AOU Maggiore della Caritа di Novara - SCDU Ematologia
Novara, , Italy
AOU di Padova - Ematologia
Padua, , Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padua, , Italy
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani, , Italy
AOU Policlinico Giaccone - Ematologia
Palermo, , Italy
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, , Italy
Ospedale Guglielmo da Saliceto - U.O.Ematologia
Piacenza, , Italy
AOU Pisana - U.O. Ematologia
Pisa, , Italy
A.O.R. "San Carlo" - U.O. Ematologia
Potenza, , Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, , Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini, , Italy
AO Sant'Andrea - Ematologia
Roma, , Italy
Ospedale S. Eugenio - UOC Ematologia
Roma, , Italy
Policlinico Tor Vergata - Ematologia
Roma, , Italy
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, , Italy
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano, , Italy
AOU di Sassari - Ematologia
Sassari, , Italy
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, , Italy
Ospedale Ca Foncello - S.C di Ematologia
Treviso, , Italy
Countries
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Central Contacts
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Facility Contacts
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Elsa Pennese, MD
Role: primary
Other Identifiers
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FIL_Lymphoma-SCP
Identifier Type: -
Identifier Source: org_study_id
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