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Recruiting NCT05934084

Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

No phase Interventional Classical Hodgkin Lymphoma Diffuse Large B Cell Lymphoma (DLBCL) Primary Mediastinal Large B-cell Lymphoma (PMBCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lifestyles Implemented-Survivorship Care Plan (LS-SCP).
Who it may be relevant to
Registry conditions: Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL). Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Global quality of life [Time frame: From study start up to 30 months]
Secondary outcome measures (12)
  • Impact of health on an individual's everyday life [Time frame: From study start up to 30 months]
  • Changes in psychosocial well-being [Time frame: From study start up to 30 months]
  • Overall survival (OS) [Time frame: From study start up to 30 months]
  • Frequencies of chronic fatigue (FAS); [Time frame: From study start up to 30 months]
  • Cognitive function [Time frame: From study start up to 30 months]
  • Metabolic outcomes -BMI [Time frame: From study start up to 30 months]
  • Metabolic outcomes - diabetes [Time frame: From study start up to 30 months]
  • Frequency cardiovascular disease [Time frame: From study start up to 30 months]
  • Compliance to screening for secondary cancers and vaccination [Time frame: From study start up to 30 months]
  • Frequency others comorbidity [Time frame: From study start up to 30 months]
  • Adherence to healthy lifestyles - healthy diet [Time frame: From study start up to 30 months]
  • Adherence to healthy lifestyles - Physical Activity [Time frame: From study start up to 30 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Italy · 40 centers
  • 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
  • … and 32 more centers

Identifiers

NCT: NCT05934084 · FIL_Lymphoma-SCP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗