Trial Title:
Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors
NCT ID:
NCT05934084
Condition:
Classical Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma (DLBCL)
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
Survivorship Care Plan
Lifestyles implemented-Survivorship Care Plan
Quality of Life
Lymphoma Survivors
Nutritional plan
Physical activity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Lifestyles Implemented-Survivorship Care Plan (LS-SCP)
Description:
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.
Arm group label:
Experimental Arm (E)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
Address:
City:
Ancona
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Guido Gini, MD
Phone:
0715964562
Email:
guido.gini@ospedaliriuniti.marche.it
Investigator:
Last name:
Guido Gini, MD
Email:
Principal Investigator
Facility:
Name:
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Address:
City:
Aviano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Spina, MD
Phone:
0434659730
Email:
mspina@cro.it
Investigator:
Last name:
Michele Spina, Dr
Email:
Principal Investigator
Facility:
Name:
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Address:
City:
Bari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carla Minoia, MD
Email:
carlaminoia980@gmail.com
Investigator:
Last name:
Carla Minoia, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Address:
City:
Barletta
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giuseppe Tarantini, MD
Phone:
0883/577942
Email:
giuseppetarantini0@gmail.com
Investigator:
Last name:
Giuseppe Tarantini, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale S. Martino - UOC Oncologia
Address:
City:
Belluno
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Fable Zustovich, MD
Phone:
0437514584
Email:
fable.zustovich@aulss1.veneto.it
Investigator:
Last name:
Fable Zustovich, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
Address:
City:
Bolzano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Gloria Turri, MD
Phone:
0471438388
Email:
gloria.turri@sabes.it
Investigator:
Last name:
Gloria Turri, MD
Email:
Principal Investigator
Facility:
Name:
ASST Spedali Civili di Brescia - Ematologia
Address:
City:
Brescia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Chiara Pagani, MD
Phone:
0303996269
Email:
chiara.pagani@asst-spedalicivili.it
Investigator:
Last name:
Chiara Pagani, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
Address:
City:
Brindisi
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Domenico Pastore, MD
Phone:
0831537506
Email:
domenico.pastore0@gmail.com
Investigator:
Last name:
Domenico Pastore, MD
Email:
Principal Investigator
Facility:
Name:
PO Sant'Elia ASP Caltanisetta - UOC Ematologia
Address:
City:
Caltanissetta
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Maria Enza Mitra, MD
Phone:
0934559106
Email:
ematologia.posantelia@asp.cl.it
Investigator:
Last name:
Maria Enza Mitra, MD
Email:
Principal Investigator
Facility:
Name:
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Address:
City:
Catania
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ugo Consoli, MD
Phone:
0957595055
Email:
ugo.consoli144@gmail.com
Investigator:
Last name:
Ugo Consoli, MD
Email:
Sub-Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Address:
City:
Catania
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Annalisa Chiarenza, MD
Phone:
095-7436155
Email:
annalisa.chiarenza@gmail.com
Investigator:
Last name:
Annalisa Chiarenza, MD
Email:
Sub-Investigator
Facility:
Name:
Ospedale Generale di zona Valduce - Oncoematologia
Address:
City:
Como
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sara Steffanoni, MD
Phone:
031324560
Email:
sara.steffanoni@gmail.com
Investigator:
Last name:
Sara Steffanoni, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
Address:
City:
Firenze
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luca Nassi, MD
Phone:
0557946445
Email:
nassil@aou-careggi.toscana.it
Investigator:
Last name:
Luca Nassi, MD
Email:
Sub-Investigator
Facility:
Name:
Ospedale Vito Fazzi - Ematologia
Address:
City:
Lecce
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Nicola Di Renzo, MD
Phone:
0832661923
Email:
direnzo.ematolecce@gmail.com
Investigator:
Last name:
Nicola Di Renzo, MD
Email:
Principal Investigator
Facility:
Name:
ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
Address:
City:
Legnano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Silvia Franceschetti, MD
Phone:
0331.449306
Email:
silvia.franceschetti@asst-ovestmi.it
Investigator:
Last name:
Silvia Franceschetti, MD
Email:
Principal Investigator
Facility:
Name:
AOU G. Martino - U.O.C. Ematologia
Address:
City:
Messina
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Allegra, MD
Phone:
Tel: 090 2213253
Email:
alessandro.allegra@unime.it
Investigator:
Last name:
Alessandro Allegra, MD
Email:
Principal Investigator
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Vittorio Ruggero Zilioli, MD
Phone:
0264442668
Email:
vittorioruggero.zilioli@ospedaleniguarda.it
Investigator:
Last name:
Vittorio Ruggero Zilioli, MD
Email:
Principal Investigator
Facility:
Name:
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Simonetta Viviani, MD
Phone:
0257489538
Email:
simonetta.viviani@ieo.it
Investigator:
Last name:
Simonetta Viviani, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Francesca Gaia Rossi, MD
Phone:
0255033466
Email:
francescagaia.rossi@policlinico.mi.it
Investigator:
Last name:
Francesca Gaia Rossi, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
Address:
City:
Modena
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessia Bari, MD
Phone:
0594224798
Email:
alessia.bari@unimore.it
Investigator:
Last name:
Alessia Bari, MD
Email:
Principal Investigator
Facility:
Name:
AOU Maggiore della Caritа di Novara - SCDU Ematologia
Address:
City:
Novara
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Riccardo Bruna, MD
Phone:
03213733880
Email:
riccardo.bruna@med.uniupo.it
Investigator:
Last name:
Riccardo Bruna, MD
Email:
Principal Investigator
Facility:
Name:
AOU di Padova - Ematologia
Address:
City:
Padova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Greta Scapinello, MD
Phone:
0498217809
Email:
greta.scapinello@aopd.veneto.it
Investigator:
Last name:
Greta Scapinello, MD
Email:
Principal Investigator
Facility:
Name:
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Address:
City:
Padova
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Dario Marino, MD
Phone:
0498215621
Email:
dario.marino@iov.veneto.it
Investigator:
Last name:
Dario Marino, MD
Email:
Principal Investigator
Facility:
Name:
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Address:
City:
Pagani
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Catello Califano, MD
Phone:
081921364
Email:
c.califano@aslsalerno.it
Investigator:
Last name:
Catello Califano, MD
Email:
Principal Investigator
Facility:
Name:
AOU Policlinico Giaccone - Ematologia
Address:
City:
Palermo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Salvatrice Mancuso, MD
Phone:
0916554505
Email:
salvatrice.mancuso@unipa.it
Investigator:
Last name:
Salvatrice Mancuso, MD
Email:
Principal Investigator
Facility:
Name:
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Address:
City:
Pescara
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elsa Pennese, MD
Investigator:
Last name:
Elsa Pennese, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Guglielmo da Saliceto - U.O.Ematologia
Address:
City:
Piacenza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annalisa Arcari, MD
Phone:
0523303724
Email:
a.arcari@ausl.pc.it
Investigator:
Last name:
Annalisa Arcari, MD
Email:
Principal Investigator
Facility:
Name:
AOU Pisana - U.O. Ematologia
Address:
City:
Pisa
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sara Galimberti, MD
Phone:
050993488
Email:
sara.galimberti@med.unipi.it
Investigator:
Last name:
Sara Galimberti, MD
Email:
Principal Investigator
Facility:
Name:
A.O.R. "San Carlo" - U.O. Ematologia
Address:
City:
Potenza
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Cimminiello, MD
Phone:
0971 612456
Email:
miki-doc@virgilio.it
Investigator:
Last name:
Michele Cimminiello, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Laura Arletti, MD
Phone:
0522296623
Email:
arletti.laura@ausl.re.it
Investigator:
Last name:
Laura Arletti, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Address:
City:
Rimini
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Francesco Rotondo, MD
Phone:
0541705603
Email:
frotondo824@gmail.com
Investigator:
Last name:
Francesco Rotondo, MD
Email:
Principal Investigator
Facility:
Name:
AO Sant'Andrea - Ematologia
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Agostino Tafuri, MD
Phone:
0633775842
Email:
agostino.tafuri@ospedalesantandrea.it
Investigator:
Last name:
Agostino Tafuri, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale S. Eugenio - UOC Ematologia
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elisabetta Abruzzese, MD
Phone:
0651008984
Email:
elisabetta.abruzzese@uniroma2.it
Investigator:
Last name:
Elisabetta Abruzzese, MD
Email:
Principal Investigator
Facility:
Name:
Policlinico Tor Vergata - Ematologia
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Anna Giulia Zizzari, MD
Phone:
0620903224
Email:
annadot86@hotmail.it
Investigator:
Last name:
Anna Giulia Zizzari, MD
Email:
Principal Investigator
Facility:
Name:
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ombretta Annibali, MD
Phone:
06225411
Email:
o.annibali@policlinicocampus.it
Investigator:
Last name:
Ombretta Annibali, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Clinico Humanitas - U.O. Ematologia
Address:
City:
Rozzano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Santoro Armando, MD
Phone:
0282244080
Email:
armando.santoro@humanitas.it
Investigator:
Last name:
Santoro Armando, MD
Email:
Principal Investigator
Facility:
Name:
AOU di Sassari - Ematologia
Address:
City:
Sassari
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Roberto Massaiu, MD
Phone:
079229883
Email:
robertomassaiu1@gmail.com
Investigator:
Last name:
Roberto Massaiu, MD
Email:
Principal Investigator
Facility:
Name:
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Address:
City:
Sassuolo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sara Bigliardi, MD
Phone:
0536846162
Email:
s.bigliardi@ausl.mo.it
Investigator:
Last name:
Sara Bigliardi, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Address:
City:
Torino
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Federica Cavallo, MD
Phone:
0116334264
Email:
f.cavallo@unito.it
Investigator:
Last name:
Federica Cavallo, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Ca Foncello - S.C di Ematologia
Address:
City:
Treviso
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elisabetta Scarpa, MD
Phone:
0422328490
Email:
elisabetta.scarpa@aulss2.veneto.it
Investigator:
Last name:
Elisabetta Scarpa, MD
Email:
Principal Investigator
Start date:
February 26, 2024
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934084
