Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое Lifestyles Implemented-Survivorship Care Plan (LS-SCP)
  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 (LS-SCP, Lifestyles implemented-Survivorship Care Plan) will be performed.

Первичные конечные точки

• Global quality of life [Срок оценки: From study start up to 30 months]

Вторичные конечные точки (12)

• Impact of health on an individual's everyday life [Срок оценки: From study start up to 30 months]
• Changes in psychosocial well-being [Срок оценки: From study start up to 30 months]
• Overall survival (OS) [Срок оценки: From study start up to 30 months]
• Frequencies of chronic fatigue (FAS); [Срок оценки: From study start up to 30 months]
• Cognitive function [Срок оценки: From study start up to 30 months]
• Metabolic outcomes -BMI [Срок оценки: From study start up to 30 months]
• Metabolic outcomes - diabetes [Срок оценки: From study start up to 30 months]
• Frequency cardiovascular disease [Срок оценки: From study start up to 30 months]
• Compliance to screening for secondary cancers and vaccination [Срок оценки: From study start up to 30 months]
• Frequency others comorbidity [Срок оценки: From study start up to 30 months]
• Adherence to healthy lifestyles - healthy diet [Срок оценки: From study start up to 30 months]
• Adherence to healthy lifestyles - Physical Activity [Срок оценки: From study start up to 30 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 40 центров

• Ancona - AOU Ospedali Riuniti - Clinica di Ematologia — Ancona
• Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei T — Aviano
• Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare — Bari
• Ospedale S. Martino - UOC Oncologia — Belluno
• Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia — Barletta
• Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O. — Bolzano
• ASST Spedali Civili di Brescia - Ematologia — Brescia
• Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo — Brindisi
• … и ещё 32 центра

Идентификаторы

NCT: NCT05934084 · FIL_Lymphoma-SCP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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