Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

Classical Hodgkin Lymphoma Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)

• NCT number: NCT05934084
• Study type: Interventional
• Source: Fondazione Italiana Linfomi - ETS
• Contact: Uffici Studi FIL
• Phone: 0599769918
• Email: startup@filinf.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: February 1, 2026