Clinical trial NCT05934084: Lifestyles Implemented-Survivorship Care Plan in Lymphoma Survivors
Official title: Lifestyles Implemented-Survivorship Care Plan in Lymphoma Survivors: a Randomized Non-pharmacological Clinical Trial by the Fondazione Italiana Linfomi (FIL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Classical Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma (DLBCL)
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Keywords: Survivorship Care Plan
Lifestyles implemented-Survivorship Care Plan
Quality of Life
Lymphoma Survivors
Nutritional plan
Physical activity
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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

Primary outcomes:
measure: Global quality of life
timeFrame: From study start up to 30 months
Secondary outcomes:
measure: Impact of health on an individual's everyday life
timeFrame: From study start up to 30 months
measure: Changes in psychosocial well-being
timeFrame: From study start up to 30 months
measure: Overall survival (OS)
timeFrame: From study start up to 30 months
measure: Frequencies of chronic fatigue (FAS);
timeFrame: From study start up to 30 months
measure: Cognitive function
timeFrame: From study start up to 30 months
measure: Metabolic outcomes -BMI
timeFrame: From study start up to 30 months
measure: Metabolic outcomes - diabetes
timeFrame: From study start up to 30 months
measure: Frequency cardiovascular disease
timeFrame: From study start up to 30 months
measure: Compliance to screening for secondary cancers and vaccination
timeFrame: From study start up to 30 months
measure: Frequency others comorbidity
timeFrame: From study start up to 30 months
measure: Adherence to healthy lifestyles - healthy diet
timeFrame: From study start up to 30 months
measure: Adherence to healthy lifestyles - Physical Activity
timeFrame: From study start up to 30 months
measure: Measure of hand grip muscle strength
timeFrame: From study start up to 30 months
measure: Frequencies of negative Life-Style factors
timeFrame: From study start up to 30 months
measure: Frequency of compliance between planned and effective follow-up via LS-SCP.
timeFrame: From study start up to 30 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
city: Aviano
country: Italy
facility: Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
city: Bari
country: Italy
facility: Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
city: Barletta
country: Italy
facility: Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
city: Belluno
country: Italy
facility: Ospedale S. Martino - UOC Oncologia
city: Bolzano
country: Italy
facility: Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia - Ematologia
city: Brindisi
country: Italy
facility: Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
city: Caltanissetta
country: Italy
facility: PO Sant'Elia ASP Caltanisetta - UOC Ematologia
city: Catania
country: Italy
facility: Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
city: Como
country: Italy
facility: Ospedale Generale di zona Valduce - Oncoematologia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi - Ematologia
city: Legnano
country: Italy
facility: ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
city: Messina
country: Italy
facility: AOU G. Martino - U.O.C. Ematologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
city: Milano
country: Italy
facility: IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
city: Novara
country: Italy
facility: AOU Maggiore della Caritа di Novara - SCDU Ematologia
city: Padova
country: Italy
facility: AOU di Padova - Ematologia
city: Padova
country: Italy
facility: I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
city: Pagani
country: Italy
facility: Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
city: Palermo
country: Italy
facility: AOU Policlinico Giaccone - Ematologia
city: Pescara
country: Italy
facility: P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto - U.O.Ematologia
city: Pisa
country: Italy
facility: AOU Pisana - U.O. Ematologia
city: Potenza
country: Italy
facility: A.O.R. "San Carlo" - U.O. Ematologia
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
city: Rimini
country: Italy
facility: Ospedale degli Infermi di Rimini - U.O. di Ematologia
city: Roma
country: Italy
facility: AO Sant'Andrea - Ematologia
city: Roma
country: Italy
facility: Ospedale S. Eugenio - UOC Ematologia
city: Roma
country: Italy
facility: Policlinico Tor Vergata - Ematologia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas - U.O. Ematologia
city: Sassari
country: Italy
facility: AOU di Sassari - Ematologia
city: Sassuolo
country: Italy
facility: Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
city: Treviso
country: Italy
facility: Ospedale Ca Foncello - S.C di Ematologia
Study officials:
affiliation: Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
name: Carla Minoia, MD
role: PRINCIPAL_INVESTIGATOR
References: