lifestyles implemented-survivorship care plan in lymphoma survivors

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

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).

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.

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

Keywords: survivorship care plan lifestyles implemented-survivorship care plan quality of life lymphoma survivors nutritional plan physical activity