Lifestyles Implemented-Survivorship Care Plan in Lymphoma Survivors

Last updated: December 30, 2024
Sponsor: Fondazione Italiana Linfomi - ETS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma, B-cell

Lymphoma

Treatment

Lifestyles Implemented-Survivorship Care Plan (LS-SCP)

Clinical Study ID

NCT05934084
FIL_Lymphoma-SCP
  • Ages 18-50
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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-2guided treatment for cHL; R-CHOP (rituximab-cyclophosphamide, doxorubicin,vincristine and prednisone) for DLBCL; R-CHOP or R-DA-EPOCH (rituximab- Dose Adaptedetoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) for PMBCL);

  • Patients in remission for a minimum 3 years since the last treatment and a maximumof 10 years;

  • Cumulative doxorubicin/ adriamycin dose received of at least 200 mg/mq (4 cycles ofchemotherapy);

  • Availability echocardiogram (ECG) and 2D-STE-echocardiography (Two-dimensionalspeckle strain echocardiography) performed no later than three months prior toenrollment;

  • Signature of a written informed consent form indicating that the patient understandsthe purpose of and procedures required for the study and is willing to participatevoluntarily in the study.

Exclusion

Exclusion Criteria:

  • Diagnosis of secondary cancer at baseline, except non-melanoma skin cancers andadequately 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, leftventricular dysfunction >/= grade 2 pericardial disease/effusion any grade,myocarditis any grade, pulmonary hypertension any grade, restrictive cardiomyopathyany 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 studyparticipation

Study Design

Total Participants: 552
Treatment Group(s): 1
Primary Treatment: Lifestyles Implemented-Survivorship Care Plan (LS-SCP)
Phase:
Study Start date:
February 26, 2024
Estimated Completion Date:
February 01, 2026

Study Description

All patients will be assessed by validated questionnaires [EORTC QLQ-C30 (Quality of Life Questionnaire), SF12 (12-item Short Form Survey), MEDI-LITE (Mediterranean Literature questionnaire), CFSS (Chronic Fatigue Syndrome Self assessment), FAS (Fatigue Assessment Scale), Hospital Anxiety and Depression Scale (HAD-S)] and clinical assessment performed at baseline, at 6 and 12 months from the randomization. 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 (Lifestyles implemented-Survivorship Care Plan (LS-SCP)) will be performed. 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.

Connect with a study center

  • Ancona - AOU Ospedali Riuniti - Clinica di Ematologia

    Ancona,
    Italy

    Site Not Available

  • Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati

    Aviano,
    Italy

    Site Not Available

  • Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare

    Bari,
    Italy

    Active - Recruiting

  • Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

    Barletta,
    Italy

    Site Not Available

  • Ospedale S. Martino - UOC Oncologia

    Belluno,
    Italy

    Site Not Available

  • Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.

    Bolzano,
    Italy

    Site Not Available

  • ASST Spedali Civili di Brescia - Ematologia

    Brescia,
    Italy

    Active - Recruiting

  • Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo

    Brindisi,
    Italy

    Site Not Available

  • PO Sant'Elia ASP Caltanisetta - UOC Ematologia

    Caltanissetta,
    Italy

    Site Not Available

  • Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia

    Catania,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia

    Catania,
    Italy

    Site Not Available

  • Ospedale Generale di zona Valduce - Oncoematologia

    Como,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia

    Firenze,
    Italy

    Site Not Available

  • Ospedale Vito Fazzi - Ematologia

    Lecce,
    Italy

    Site Not Available

  • ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano

    Legnano,
    Italy

    Active - Recruiting

  • AOU G. Martino - U.O.C. Ematologia

    Messina,
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

    Milano,
    Italy

    Site Not Available

  • IEO Istitito Europeo di Oncologia - Divisione Ematoncologia

    Milano,
    Italy

    Active - Recruiting

  • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia

    Milano,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia

    Modena,
    Italy

    Active - Recruiting

  • AOU Maggiore della Caritа di Novara - SCDU Ematologia

    Novara,
    Italy

    Site Not Available

  • AOU di Padova - Ematologia

    Padova,
    Italy

    Site Not Available

  • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

    Padova,
    Italy

    Active - Recruiting

  • Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

    Pagani,
    Italy

    Site Not Available

  • AOU Policlinico Giaccone - Ematologia

    Palermo,
    Italy

    Site Not Available

  • P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

    Pescara,
    Italy

    Site Not Available

  • Ospedale Guglielmo da Saliceto - U.O.Ematologia

    Piacenza,
    Italy

    Active - Recruiting

  • AOU Pisana - U.O. Ematologia

    Pisa,
    Italy

    Site Not Available

  • A.O.R. "San Carlo" - U.O. Ematologia

    Potenza,
    Italy

    Site Not Available

  • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

    Reggio Emilia,
    Italy

    Site Not Available

  • Ospedale degli Infermi di Rimini - U.O. di Ematologia

    Rimini,
    Italy

    Site Not Available

  • AO Sant'Andrea - Ematologia

    Roma,
    Italy

    Site Not Available

  • Ospedale S. Eugenio - UOC Ematologia

    Roma,
    Italy

    Site Not Available

  • Policlinico Tor Vergata - Ematologia

    Roma,
    Italy

    Site Not Available

  • Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare

    Roma,
    Italy

    Site Not Available

  • Istituto Clinico Humanitas - U.O. Ematologia

    Rozzano,
    Italy

    Site Not Available

  • AOU di Sassari - Ematologia

    Sassari,
    Italy

    Site Not Available

  • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico

    Sassuolo,
    Italy

    Site Not Available

  • A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria

    Torino,
    Italy

    Site Not Available

  • Ospedale Ca Foncello - S.C di Ematologia

    Treviso,
    Italy

    Site Not Available

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