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RECRUITING Not applicable ClinicalTrials.gov

Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

Sponsor: Fondazione Italiana Linfomi - ETS • ClinicalTrials.gov ID: NCT05934084

Registry updated: 2026-09-11
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Description

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).

Interventions

  • Lifestyles Implemented-Survivorship Care Plan (LS-SCP) (Behavioral)
    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

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

Conditions

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

Locations

  • 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 — Padova, Italy
  • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 — Padova, 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 G. Martino - U.O.C. 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record