NCT05934084

Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 552 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2023-07-06
• Last updated: 2026-01-12

Locations

40 sites across 1 country: Italy