P096 | LIFESTYLES IMPLEMENTED-SURVIVORSHIP CARE PLAN IN LYMPHOMA SURVIVORS: AN ONGOING RANDOMIZED CLINICAL TRIAL BY THE FONDAZIONE ITALIANA LINFOMI

INTRODUCTION. Several studies have demonstrated how the control of unhealthy lifestyles can reduce the incidence of late toxicities of oncologic treatments, especially cardiovascular ones, in patients treated at a young age for lymphoma, and therefore reduce their comorbidities and improve quality of life over the years. At the moment there are no validated tools to guide the follow-up of lymphoma survivors and to apply tertiary prevention. METHODS. This is a prospective randomized open-label, multicenter, 2-arm study to assess the role of lifestyle implemented Survivorship Care Plan (LS-SCP) in modifying the quality of life (QoL) in a population of long-term lymphoma survivors. FIL researchers designed a LS-SCP directed to lymphoma survivors finalized to structure the long-term monitoring and empower the patients' knowledge on healthy lifestyles as an instrument of tertiary prevention. The LS-SCP has been built by stratifying the risk factors for cardiovascular diseases, endocrine-metabolic sequelae, and second cancers. Specific nutritional indications and an adapted physical activity schedule, designed according specialistic guide lines, were added to the LS-SCP. We planned to enroll patients treated for Hodgkin Lymphoma, Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma at 18-50 years old and in remission for 3-10 years (Figure 1). By PROs, laboratory and clinical assessments at baseline, +6 months and +12 months, the LS-SCP will be tested in the present randomized study in order to validate its power to ameliorate quality of life (EORTC QLQ-C30, SF-12), cognitive status (CFSS), fatigue (FAS), psycho-social wellbeing (HAD-S), cardiovascular and metabolic conditions, as well as the adherence to healthy lifestyles (MEDILITE, IPAQ) in comparison to an unstructured follow-up. The study has been registered at clinicaltrial.gov as NCT05934084 and is actually enrolling lymphoma survivor patients. 25 of the 39 involved FIL centers are currently active. The first 66 patients have been enrolled as of 25 April 2024 This study will lead to the validation of a specific LS-SCP model for patients treated for lymphoma between the ages of 18 and 50 and tailored for tertiary prevention of late toxicities. LS-SCP could be a powerful tool for patients' empowerment and for tertiary prevention, reducing comorbidities and improving quality of life. Figure 1 - Study flow-chart.