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
- Diseases
- Diffuse large B-cell lymphoma
- 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
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ancona - AOU Ospedali Riuniti - Clinica di Ematologia Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia Coordinator of this site? Confirm its status | Barletta | Italy | Recruiting |
| Ospedale S. Martino - UOC Oncologia Coordinator of this site? Confirm its status | Belluno | Italy | Recruiting |
| Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O. Coordinator of this site? Confirm its status | Bolzano | Italy | Recruiting |
| ASST Spedali Civili di Brescia, Ematologia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo Coordinator of this site? Confirm its status | Brindisi | Italy | Recruiting |
| PO Sant'Elia ASP Caltanisetta - UOC Ematologia Coordinator of this site? Confirm its status | Caltanissetta | Italy | Not yet recruiting |
| Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Ospedale Generale di zona Valduce - Oncoematologia Coordinator of this site? Confirm its status | Como | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale Vito Fazzi - Ematologia Coordinator of this site? Confirm its status | Lecce | Italy | Recruiting |
| ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano Coordinator of this site? Confirm its status | Legnano | Italy | Recruiting |
| AOU G. Martino - U.O.C. Ematologia Coordinator of this site? Confirm its status | Messina | Italy | Not yet recruiting |
| ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - Ematologia Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IEO Istitito Europeo di Oncologia - Divisione Ematoncologia Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| AOU Maggiore della Caritа di Novara, SCDU Ematologia Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| AOU di Padova - Ematologia Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Presidio ospedaliero A. Tortora, U.O. Onco-ematologia Coordinator of this site? Confirm its status | Pagani | Italy | Recruiting |
| AOU Policlinico Giaccone - Ematologia Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi Coordinator of this site? Confirm its status | Pescara | Italy | Recruiting |
| Ospedale Guglielmo da Saliceto - U.O. Ematologia Coordinator of this site? Confirm its status | Piacenza | Italy | Recruiting |
| AOU G. Martino - U.O.C. Ematologia Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| A.O.R. "San Carlo" - U.O. Ematologia Coordinator of this site? Confirm its status | Potenza | Italy | Not yet recruiting |
| Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Ospedale degli Infermi di Rimini - U.O. di Ematologia Coordinator of this site? Confirm its status | Rimini | Italy | Recruiting |
| Ospedale S. Eugenio - UOC Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| AO Sant'Andrea - Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Policlinico Tor Vergata - Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Istituto Clinico Humanitas - U.O. Ematologia Coordinator of this site? Confirm its status | Rozzano | Italy | Withdrawn |
| AOU di Sassari - Ematologia Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
| Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico Coordinator of this site? Confirm its status | Sassuolo | Italy | Recruiting |
| A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Ospedale Ca Foncello - S.C di Ematologia Coordinator of this site? Confirm its status | Treviso | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.