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โ† Trials
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Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

RecruitingNAAges 18 Years - 50 YearsAllFondazione Italiana Linfomi - ETS
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

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

40 sites
Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Italy
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Italy
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari, Italy
Ospedale S. Martino - UOC Oncologia
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

โ€ฆand 32 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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