Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors: A Randomized Non-pharmacological Clinical Trial By The Fondazione Italiana Linfomi (FIL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 552
- 试验地点
- 47
- 主要终点
- Global quality of life
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Control Arm (C)
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.
Experimental Arm (E)
Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months.
干预措施: Lifestyles Implemented-Survivorship Care Plan (LS-SCP) (Behavioral)
结局指标
主要结局
Global quality of life
时间窗: From study start up to 30 months
The endpoint will be assessed by the European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) that will be submitted to patients. The EORTC QLQ-C30 consists of 30 items including five functioning scales (physical functioning, social functioning, role functioning, emotional functioning and cognitive functioning), nine symptom scales (fatigue, pain, nausea-vomiting, dyspnoea, sleep disturbances, appetite loss, diarrhoea, constipation and financial difficulties), and a global health status or quality of life (QOL) scale. On the 100-point metric, high scores for functioning scales and the global health status, or QOL, scale indicate high HR (health-related) QOL, while high scores on the symptom scales indicate a high symptom burden.
次要结局
- Impact of health on an individual's everyday life(From study start up to 30 months)
- Metabolic outcomes - diabetes(From study start up to 30 months)
- Frequency of compliance between planned and effective follow-up via LS-SCP.(From study start up to 30 months)
- Frequencies of chronic fatigue (FAS);(From study start up to 30 months)
- Cognitive function(From study start up to 30 months)
- Metabolic outcomes -BMI(From study start up to 30 months)
- Adherence to healthy lifestyles - healthy diet(From study start up to 30 months)
- Compliance to screening for secondary cancers and vaccination(From study start up to 30 months)
- Adherence to healthy lifestyles - Physical Activity(From study start up to 30 months)
- Measure of hand grip muscle strength(From study start up to 30 months)
- Frequency others comorbidity(From study start up to 30 months)
- Changes in psychosocial well-being(From study start up to 30 months)
- Frequency cardiovascular disease(From study start up to 30 months)
- Frequencies of negative Life-Style factors(From study start up to 30 months)
- Overall survival (OS)(From study start up to 30 months)