Classical Hodgkin LymphomaNCT05934084
Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors
A study testing Lifestyles Implemented-Survivorship Care Plan (LS-SCP) in people with Classical Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma (DLBCL), run by Fondazione Italiana Linfomi - ETS at 40 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- What is being tested?
- Lifestyles Implemented-Survivorship Care Plan (LS-SCP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 40 sitesItaly
- Study dates
- 26 Feb 2024to 1 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uffici Studi FIL contact
40 sites in 1 country
Italy40 sites, 39 recruiting
- Recruiting
Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Ancona
Guido Gini, MD, 0715964562, guido.gini@ospedaliriuniti.marche.it
Guido Gini, MD
- Recruiting
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Aviano
Rosanna Ciancia, MD, 0434/659645, rciancia@cro.it
Rosanna Ciancia, Dr
- Recruiting
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari, Bari
Carla Minoia, MD, carlaminoia980@gmail.com
Carla Minoia, MD
- Recruiting
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta
Giuseppe Tarantini, MD, 0883/577942, giuseppetarantini0@gmail.com
Giuseppe Tarantini, MD
- Recruiting
Ospedale S. Martino - UOC Oncologia
Belluno, Belluno
Fable Zustovich, MD, 0437514584, fable.zustovich@aulss1.veneto.it
Fable Zustovich, MD
- Recruiting
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
Bolzano
Gloria Turri, MD, 0471438388, gloria.turri@sabes.it
Gloria Turri, MD
- Recruiting
ASST Spedali Civili di Brescia - Ematologia
Brescia
Chiara Pagani, MD, 0303996269, chiara.pagani@asst-spedalicivili.it
Chiara Pagani, MD
- Recruiting
Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
Brindisi
Domenico Pastore, MD, 0831537506, domenico.pastore0@gmail.com
Domenico Pastore, MD
- Not yet recruiting
PO Sant'Elia ASP Caltanisetta - UOC Ematologia
Caltanissetta
Maria Enza Mitra, MD, ematologia.posantelia@asp.cl.it
- Recruiting
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania
Ugo Consoli, MD, 0957595055, ugo.consoli144@gmail.com
Ugo Consoli, MD
- Recruiting
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Catania
Annalisa Chiarenza, MD, 095-7436155, annalisa.chiarenza@gmail.com
Annalisa Chiarenza, MD
- Recruiting
Ospedale Generale di zona Valduce - Oncoematologia
Como
Sara Steffanoni, MD, 031324560, sara.steffanoni@gmail.com
Sara Steffanoni, MD
- Recruiting
Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
Florence
Luca Nassi, MD, 0557946445, nassil@aou-careggi.toscana.it
Luca Nassi, MD
- Recruiting
Ospedale Vito Fazzi - Ematologia
Lecce
Nicola Di Renzo, MD, 0832661923, direnzo.ematolecce@gmail.com
Nicola Di Renzo, MD
- Recruiting
ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
Legnano
Silvia Franceschetti, MD, 0331.449306, silvia.franceschetti@asst-ovestmi.it
Silvia Franceschetti, MD
- Not yet recruiting
AOU G. Martino - U.O.C. Ematologia
Messina
Alessandro Allegra, MD, alessandro.allegra@unime.it
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan
Vittorio Ruggero Zilioli, MD, 0264442668, vittorioruggero.zilioli@ospedaleniguarda.it
Vittorio Ruggero Zilioli, MD
- Recruiting
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
Milan
Simonetta Viviani, MD, 0257489538, simonetta.viviani@ieo.it
Simonetta Viviani, MD
- Recruiting
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
Milan
Francesca Gaia Rossi, MD, 0255033466, francescagaia.rossi@policlinico.mi.it
Francesca Gaia Rossi, MD
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
Modena
Alessia Bari, MD, 0594224798, alessia.bari@unimore.it
Alessia Bari, MD
- Recruiting
AOU Maggiore della Caritа di Novara - SCDU Ematologia
Novara
Riccardo Bruna, MD, 03213733880, riccardo.bruna@med.uniupo.it
Riccardo Bruna, MD
- Recruiting
AOU di Padova - Ematologia
Padova
Greta Scapinello, MD, 0498217809, greta.scapinello@aopd.veneto.it
Greta Scapinello, MD
- Recruiting
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padova
Dario Marino, MD, 0498215621, dario.marino@iov.veneto.it
Dario Marino, MD
- Recruiting
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani
Catello Califano, MD, 081921364, c.califano@aslsalerno.it
Catello Califano, MD
- Recruiting
AOU Policlinico Giaccone - Ematologia
Palermo
Salvatrice Mancuso, MD, 0916554505, salvatrice.mancuso@unipa.it
Salvatrice Mancuso, MD
- Recruiting
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara
Elsa Pennese, MD
Elsa Pennese, MD
- Recruiting
Ospedale Guglielmo da Saliceto - U.O.Ematologia
Piacenza
Annalisa Arcari, MD, 0523303724, a.arcari@ausl.pc.it
Annalisa Arcari, MD
- Not yet recruiting
AOU G. Martino - U.O.C. Ematologia
Pisa
Sara Galimberti, MD, sara.galimberti@med.unipi.it
- Not yet recruiting
A.O.R. "San Carlo" - U.O. Ematologia
Potenza
Michele Cimminiello, MD, miki-doc@virgilio.it
- Recruiting
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia
Laura Arletti, MD, 0522296623, arletti.laura@ausl.re.it
Laura Arletti, MD
- Recruiting
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini
Francesco Rotondo, MD, 0541705603, frotondo824@gmail.com
Francesco Rotondo, MD
- Recruiting
AO Sant'Andrea - Ematologia
Roma
Agostino Tafuri, MD, 0633775842, agostino.tafuri@ospedalesantandrea.it
Agostino Tafuri, MD
- Recruiting
Ospedale S. Eugenio - UOC Ematologia
Roma
Elisabetta Abruzzese, MD, 0651008984, elisabetta.abruzzese@uniroma2.it
Elisabetta Abruzzese, MD
- Not yet recruiting
Policlinico Tor Vergata - Ematologia
Roma
Anna Giulia Zizzari, MD, annadot86@hotmail.it
- Recruiting
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma
Ombretta Annibali, MD, 06225411, o.annibali@policlinicocampus.it
Ombretta Annibali, MD
- Withdrawn
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano
- Recruiting
AOU di Sassari - Ematologia
Sassari
Roberto Massaiu, MD, 079229883, robertomassaiu1@gmail.com
Roberto Massaiu, MD
- Recruiting
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo
Sara Bigliardi, MD, 0536846162, s.bigliardi@ausl.mo.it
Sara Bigliardi, MD
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino
Federica Cavallo, MD, 0116334264, f.cavallo@unito.it
Federica Cavallo, MD
- Recruiting
Ospedale Ca Foncello - S.C di Ematologia
Treviso
Elisabetta Scarpa, MD, 0422328490, elisabetta.scarpa@aulss2.veneto.it
Elisabetta Scarpa, MD
About this study
Official title: 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).
Read the 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)
- Being tested
- Lifestyles Implemented-Survivorship Care Plan (LS-SCP)
- Keywords
- Survivorship Care Plan, Lifestyles implemented-Survivorship Care Plan, Quality of Life, Lymphoma Survivors, Nutritional plan, Physical activity
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyles Implemented-Survivorship Care Plan (LS-SCP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (C) | No intervention | 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 Arm (E) | Experimental | Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months. Receives: Behavioral: Lifestyles Implemented-Survivorship Care Plan (LS-SCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global quality of life
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.
Measured: From study start up to 30 months
Secondary outcomes (15)
Impact of health on an individual's everyday life
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.
Measured: From study start up to 30 months
Changes in psychosocial well-being
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.
Measured: From study start up to 30 months
Overall survival (OS)
Overall survival, the percentage of patients alive of the cohort
Measured: From study start up to 30 months
Frequencies of chronic fatigue (FAS);
The number of times chronic fatigue is recorded in the cohort of patients
Measured: From study start up to 30 months
Cognitive function
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.
Measured: From study start up to 30 months
Metabolic outcomes -BMI
Body Mass Index (BMI) will be evaluated for every patient. Weight and height will be combined to report BMI in kg/m^2.
Measured: From study start up to 30 months
Metabolic outcomes - diabetes
Number of patients of the cohort with diabetes
Measured: From study start up to 30 months
Frequency cardiovascular disease
The number of times cardiovascular disease is observed in the cohort of patients
Measured: From study start up to 30 months
Compliance to screening for secondary cancers and vaccination
The number of times patients undergo screening and prevention for secondary cancers
Measured: From study start up to 30 months
Frequency others comorbidity
The number of times others comorbidities are observed in the cohort of patients
Measured: From study start up to 30 months
Adherence to healthy lifestyles - healthy diet
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).
Measured: From study start up to 30 months
Adherence to healthy lifestyles - Physical Activity
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.
Measured: From study start up to 30 months
Measure of hand grip muscle strength
This end point will be measured through the use of the hand-grip dynamometer
Measured: From study start up to 30 months
Frequencies of negative Life-Style factors
Number of negative Life-Style factors associated with cardiotoxicity and metabolic syndrome.
Measured: From study start up to 30 months
Frequency of compliance between planned and effective follow-up via LS-SCP.
Number of times the plan prescribed by the LS-SCP is adhered to correctly in the cohort of patients
Measured: From study start up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start26 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a longitudinal study with two time-points (6 months and 12 months) after baseline (time 0) and the data will be evaluated by means of ANOVA for repeated measures, considering as baseline the global QoL of 75.
- Masking
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla Minoia, MD, Principal investigator, Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934084
- Sponsor's protocol ID
- FIL_Lymphoma-SCP
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No