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NCT05934084Recruiting

Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors: A Randomized Non-pharmacological Clinical Trial By The Fondazione Italiana Linfomi (FIL)

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
552 (estimated)
First submitted
13 Jun 2023
Start date
26 Feb 2024
Primary completion date
1 Feb 2027
Lead sponsor
Fondazione Italiana Linfomi - ETS
NCT number
NCT05934084

What you commit to

  • Study type: Interventional
  • Planned participants: 552
  • From 26 Feb 2024 to the primary completion date, 1 Feb 2027
  • 40 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Second line chemotherapy of stem cell transplant;

Other illness

  • Diagnosis of secondary cancer at baseline, except non-melanoma skin cancers and adequately treated cone-biopsied in situ carcinoma of the cervix;
  • 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;
  • Rheumatic disease or inflammatory bowel disease in systemic treatment;

Other

  • Not able to perform physical activity;
  • Grade \>/=3 neuropathy;
  • Vertebral fractures or stenosis of the vertebral canal; other bone fracture;
  • Chronic lymphedema (arms and/ or limbs);
  • Any pleural effusion;
  • If female, the patient is pregnant;
  • Unwilling to comply to all required visits and procedures for the duration of study participation

Who the study is looking for

  • 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.

Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
Coordinator of this site? Confirm its status
AnconaItalyRecruiting
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Coordinator of this site? Confirm its status
AvianoItalyRecruiting
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Coordinator of this site? Confirm its status
BariItalyRecruiting
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Coordinator of this site? Confirm its status
BarlettaItalyRecruiting
Ospedale S. Martino - UOC Oncologia
Coordinator of this site? Confirm its status
BellunoItalyRecruiting
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
Coordinator of this site? Confirm its status
BolzanoItalyRecruiting
ASST Spedali Civili di Brescia, Ematologia
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
Coordinator of this site? Confirm its status
BrindisiItalyRecruiting
PO Sant'Elia ASP Caltanisetta - UOC Ematologia
Coordinator of this site? Confirm its status
CaltanissettaItalyNot yet recruiting
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Coordinator of this site? Confirm its status
CataniaItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Coordinator of this site? Confirm its status
CataniaItalyRecruiting
Ospedale Generale di zona Valduce - Oncoematologia
Coordinator of this site? Confirm its status
ComoItalyRecruiting
Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Ospedale Vito Fazzi - Ematologia
Coordinator of this site? Confirm its status
LecceItalyRecruiting
ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
Coordinator of this site? Confirm its status
LegnanoItalyRecruiting
AOU G. Martino - U.O.C. Ematologia
Coordinator of this site? Confirm its status
MessinaItalyNot yet recruiting
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - Ematologia
Coordinator of this site? Confirm its status
MilanItalyRecruiting
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
Coordinator of this site? Confirm its status
ModenaItalyRecruiting
AOU Maggiore della Caritа di Novara, SCDU Ematologia
Coordinator of this site? Confirm its status
NovaraItalyRecruiting
AOU di Padova - Ematologia
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
Presidio ospedaliero A. Tortora, U.O. Onco-ematologia
Coordinator of this site? Confirm its status
PaganiItalyRecruiting
AOU Policlinico Giaccone - Ematologia
Coordinator of this site? Confirm its status
PalermoItalyRecruiting
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Coordinator of this site? Confirm its status
PescaraItalyRecruiting
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Coordinator of this site? Confirm its status
PiacenzaItalyRecruiting
AOU G. Martino - U.O.C. Ematologia
Coordinator of this site? Confirm its status
PisaItalyNot yet recruiting
A.O.R. "San Carlo" - U.O. Ematologia
Coordinator of this site? Confirm its status
PotenzaItalyNot yet recruiting
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyRecruiting
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Coordinator of this site? Confirm its status
RiminiItalyRecruiting
Ospedale S. Eugenio - UOC Ematologia
Coordinator of this site? Confirm its status
RomaItalyRecruiting
AO Sant'Andrea - Ematologia
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RomaItalyRecruiting
Policlinico Tor Vergata - Ematologia
Coordinator of this site? Confirm its status
RomaItalyNot yet recruiting
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Coordinator of this site? Confirm its status
RomaItalyRecruiting
Istituto Clinico Humanitas - U.O. Ematologia
Coordinator of this site? Confirm its status
RozzanoItalyWithdrawn
AOU di Sassari - Ematologia
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SassariItalyRecruiting
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Coordinator of this site? Confirm its status
SassuoloItalyRecruiting
A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria
Coordinator of this site? Confirm its status
TorinoItalyRecruiting
Ospedale Ca Foncello - S.C di Ematologia
Coordinator of this site? Confirm its status
TrevisoItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.