Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

January 9, 2026 updated by: Fondazione Italiana Linfomi - ETS

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

552

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Barletta, Italy
        • Recruiting
        • Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
        • Contact:
        • Principal Investigator:
          • Giuseppe Tarantini, MD
      • Bolzano, Italy
        • Recruiting
        • Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
        • Contact:
        • Principal Investigator:
          • Gloria Turri, MD
      • Brescia, Italy
        • Recruiting
        • ASST Spedali Civili di Brescia - Ematologia
        • Contact:
        • Principal Investigator:
          • Chiara Pagani, MD
      • Brindisi, Italy
        • Recruiting
        • Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
        • Principal Investigator:
          • Domenico Pastore, MD
        • Contact:
      • Caltanissetta, Italy
        • Not yet recruiting
        • PO Sant'Elia ASP Caltanisetta - UOC Ematologia
        • Contact:
        • Principal Investigator:
          • Maria Enza Mitra, MD
      • Catania, Italy
        • Recruiting
        • Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
        • Contact:
        • Sub-Investigator:
          • Ugo Consoli, MD
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
        • Contact:
        • Sub-Investigator:
          • Annalisa Chiarenza, MD
      • Como, Italy
        • Recruiting
        • Ospedale Generale di zona Valduce - Oncoematologia
        • Contact:
        • Principal Investigator:
          • Sara Steffanoni, MD
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
        • Contact:
        • Sub-Investigator:
          • Luca Nassi, MD
      • Lecce, Italy
        • Not yet recruiting
        • Ospedale Vito Fazzi - Ematologia
        • Contact:
        • Principal Investigator:
          • Nicola Di Renzo, MD
      • Legnano, Italy
        • Recruiting
        • ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
        • Contact:
        • Principal Investigator:
          • Silvia Franceschetti, MD
      • Messina, Italy
        • Not yet recruiting
        • AOU G. Martino - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandro Allegra, MD
      • Milan, Italy
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
        • Principal Investigator:
          • Vittorio Ruggero Zilioli, MD
        • Contact:
      • Milan, Italy
        • Recruiting
        • IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
        • Contact:
        • Principal Investigator:
          • Simonetta Viviani, MD
      • Milan, Italy
        • Recruiting
        • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
        • Principal Investigator:
          • Francesca Gaia Rossi, MD
        • Contact:
      • Modena, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
        • Principal Investigator:
          • Alessia Bari, MD
        • Contact:
      • Novara, Italy
        • Not yet recruiting
        • AOU Maggiore della Caritа di Novara - SCDU Ematologia
        • Contact:
        • Principal Investigator:
          • Riccardo Bruna, MD
      • Padua, Italy
        • Recruiting
        • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
        • Principal Investigator:
          • Dario Marino, MD
        • Contact:
      • Padua, Italy
        • Recruiting
        • AOU di Padova - Ematologia
        • Contact:
        • Principal Investigator:
          • Greta Scapinello, MD
      • Pagani, Italy
        • Recruiting
        • Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
        • Principal Investigator:
          • Catello Califano, MD
        • Contact:
      • Palermo, Italy
        • Recruiting
        • AOU Policlinico Giaccone - Ematologia
        • Principal Investigator:
          • Salvatrice Mancuso, MD
        • Contact:
      • Pescara, Italy
        • Recruiting
        • P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
        • Principal Investigator:
          • Elsa Pennese, MD
        • Contact:
          • Elsa Pennese, MD
      • Piacenza, Italy
        • Recruiting
        • Ospedale Guglielmo da Saliceto - U.O.Ematologia
        • Principal Investigator:
          • Annalisa Arcari, MD
        • Contact:
      • Pisa, Italy
        • Not yet recruiting
        • AOU Pisana - U.O. Ematologia
        • Principal Investigator:
          • Sara Galimberti, MD
        • Contact:
      • Potenza, Italy
        • Not yet recruiting
        • A.O.R. "San Carlo" - U.O. Ematologia
        • Principal Investigator:
          • Michele Cimminiello, MD
        • Contact:
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
        • Contact:
        • Principal Investigator:
          • Laura Arletti, MD
      • Rimini, Italy
        • Recruiting
        • Ospedale degli Infermi di Rimini - U.O. di Ematologia
        • Contact:
        • Principal Investigator:
          • Francesco Rotondo, MD
      • Roma, Italy
        • Not yet recruiting
        • Policlinico Tor Vergata - Ematologia
        • Contact:
        • Principal Investigator:
          • Anna Giulia Zizzari, MD
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
        • Principal Investigator:
          • Ombretta Annibali, MD
        • Contact:
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Ospedale S. Eugenio - UOC Ematologia
        • Contact:
        • Principal Investigator:
          • Elisabetta Abruzzese, MD
      • Rozzano, Italy
        • Withdrawn
        • Istituto Clinico Humanitas - U.O. Ematologia
      • Sassari, Italy
        • Not yet recruiting
        • AOU di Sassari - Ematologia
        • Contact:
        • Principal Investigator:
          • Roberto Massaiu, MD
      • Sassuolo, Italy
        • Recruiting
        • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
        • Principal Investigator:
          • Sara Bigliardi, MD
        • Contact:
      • Torino, Italy
        • Recruiting
        • A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
        • Principal Investigator:
          • Federica Cavallo, MD
        • Contact:
      • Treviso, Italy
        • Recruiting
        • Ospedale Ca Foncello - S.C di Ematologia
        • Principal Investigator:
          • Elisabetta Scarpa, MD
        • Contact:
    • Ancona
      • Ancona, Ancona, Italy
        • Recruiting
        • Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
        • Principal Investigator:
          • Guido Gini, MD
        • Contact:
    • Aviano
      • Aviano, Aviano, Italy
        • Recruiting
        • Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
        • Contact:
        • Principal Investigator:
          • Rosanna Ciancia, Dr
    • Bari
      • Bari, Bari, Italy
        • Recruiting
        • Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
        • Principal Investigator:
          • Carla Minoia, MD
        • Contact:
    • Belluno
      • Belluno, Belluno, Italy
        • Not yet recruiting
        • Ospedale S. Martino - UOC Oncologia
        • Principal Investigator:
          • Fable Zustovich, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global quality of life
Time Frame: 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.
From study start up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of health on an individual's everyday life
Time Frame: From study start up to 30 months
The endpoint will be assessed by the 12-Item Short Form Survey (SF-12) which will be submitted to patients. Survey scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
From study start up to 30 months
Changes in psychosocial well-being
Time Frame: From study start up to 30 months
The endpoint will be assessed by Hospital Anxiety and Depression Scale (HAD-S) questionnaire which will be submitted to patients. The HAD-S questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
From study start up to 30 months
Overall survival (OS)
Time Frame: From study start up to 30 months
Overall survival, the percentage of patients alive of the cohort
From study start up to 30 months
Frequencies of chronic fatigue (FAS);
Time Frame: From study start up to 30 months
The number of times chronic fatigue is recorded in the cohort of patients
From study start up to 30 months
Cognitive function
Time Frame: From study start up to 30 months

The endpoint will be assessed by Cognitive Functioning Self-Assessment Scale (CFSS) questionnaire which will be submitted to patients.

The Cognitive Functioning Self-Assessment Scale (CFSS) is a questionnaire designed for the self-reporting of cognitive functioning.

Its 18 items cover cognitive domains such as attention, memory and spatial-temporal orientation. Each item describes an activity of daily life in which these domains are involved. Participants answer each item on a 5-point frequency scale, referring to the past 12 months. The tool provides an overall score, calculated as the mean of the scores on individual items, where higher values indicate a worse self-perception regarding cognitive functioning.
From study start up to 30 months
Metabolic outcomes -BMI
Time Frame: From study start up to 30 months
Body Mass Index (BMI) will be evaluated for every patient. Weight and height will be combined to report BMI in kg/m^2.
From study start up to 30 months
Metabolic outcomes - diabetes
Time Frame: From study start up to 30 months
Number of patients of the cohort with diabetes
From study start up to 30 months
Frequency cardiovascular disease
Time Frame: From study start up to 30 months
The number of times cardiovascular disease is observed in the cohort of patients
From study start up to 30 months
Compliance to screening for secondary cancers and vaccination
Time Frame: From study start up to 30 months
The number of times patients undergo screening and prevention for secondary cancers
From study start up to 30 months
Frequency others comorbidity
Time Frame: From study start up to 30 months
The number of times others comorbidities are observed in the cohort of patients
From study start up to 30 months
Adherence to healthy lifestyles - healthy diet
Time Frame: From study start up to 30 months
The endpoint will be assessed by MEDI-LITE (Mediterranean Literature) questionnaire that will be submitted to patients. Adherence to the Mediterranean diet assessed through the Medi-Lite score was found to be associated with abdominal obesity. The final score, obtained by summing these values, varies from 0 (low adherence) to 18 (high adherence).
From study start up to 30 months
Adherence to healthy lifestyles - Physical Activity
Time Frame: From study start up to 30 months
The endpoint will be assessed by IPAQ (International Physical Activity Questionnaire) that will be submitted to patients. This questionnaire measures the type and amount of physical activity the patient normally does. The questions refer to activity during the past 7 days at work, getting from place to place, and during leisure time. For the purpose of the questionnaire: one minute per week (MET) is what a patient consumes at rest. Therefore, 2 METS is twice what a patient spends at rest. To obtain a continuous variable score from the IPAQ (MET minutes per week), we will consider walking as 3.3 METS, moderate physical activity as 4 METS, and vigorous physical activity as 8 METS.
From study start up to 30 months
Measure of hand grip muscle strength
Time Frame: From study start up to 30 months
This end point will be measured through the use of the hand-grip dynamometer
From study start up to 30 months
Frequencies of negative Life-Style factors
Time Frame: From study start up to 30 months
Number of negative Life-Style factors associated with cardiotoxicity and metabolic syndrome.
From study start up to 30 months
Frequency of compliance between planned and effective follow-up via LS-SCP.
Time Frame: From study start up to 30 months
Number of times the plan prescribed by the LS-SCP is adhered to correctly in the cohort of patients
From study start up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Carla Minoia, MD, Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_Lymphoma-SCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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