Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors
Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL)
About this trial
This is an interventional other trial for Classical Hodgkin Lymphoma focused on measuring Survivorship Care Plan, Lifestyles implemented-Survivorship Care Plan, Quality of Life, Lymphoma Survivors, Nutritional plan, Physical activity
Eligibility Criteria
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
Sites / Locations
- Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
- Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
- Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
- Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
- Ospedale S. Martino - UOC Oncologia
- Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
- ASST Spedali Civili di Brescia - Ematologia
- Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
- PO Sant'Elia ASP Caltanisetta - UOC Ematologia
- Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
- Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
- Ospedale Generale di zona Valduce - Oncoematologia
- Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
- Ospedale Vito Fazzi - Ematologia
- ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
- AOU G. Martino - U.O.C. Ematologia
- ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
- IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
- Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
- Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
- AOU Maggiore della Caritа di Novara - SCDU Ematologia
- AOU di Padova - Ematologia
- I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
- Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
- AOU Policlinico Giaccone - Ematologia
- P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
- Ospedale Guglielmo da Saliceto - U.O.Ematologia
- AOU Pisana - U.O. Ematologia
- A.O.R. "San Carlo" - U.O. Ematologia
- Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
- Ospedale degli Infermi di Rimini - U.O. di Ematologia
- AO Sant'Andrea - Ematologia
- Ospedale S. Eugenio - UOC Ematologia
- Policlinico Tor Vergata - Ematologia
- Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
- Istituto Clinico Humanitas - U.O. Ematologia
- AOU di Sassari - Ematologia
- Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
- A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
- Ospedale Ca Foncello - S.C di Ematologia
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control Arm (C)
Experimental Arm (E)
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.
Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months.