Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors
1 other identifier
interventional
552
1 country
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Typical duration for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedStudy Start
First participant enrolled
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedJanuary 12, 2026
January 1, 2026
1.9 years
June 13, 2023
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From study start up to 30 months
Secondary Outcomes (15)
Impact of health on an individual's everyday life
From study start up to 30 months
Changes in psychosocial well-being
From study start up to 30 months
Overall survival (OS)
From study start up to 30 months
Frequencies of chronic fatigue (FAS);
From study start up to 30 months
Cognitive function
From study start up to 30 months
- +10 more secondary outcomes
Study Arms (2)
Control Arm (C)
NO INTERVENTIONPatients 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)
EXPERIMENTALPatients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Ancona, Italy
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Aviano, Italy
Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari, Bari, Italy
Ospedale S. Martino - UOC Oncologia
Belluno, Belluno, Italy
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, Italy
Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
Bolzano, Italy
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
Brindisi, Italy
PO Sant'Elia ASP Caltanisetta - UOC Ematologia
Caltanissetta, Italy
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania, Italy
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Catania, Italy
Ospedale Generale di zona Valduce - Oncoematologia
Como, Italy
Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia
Florence, Italy
Ospedale Vito Fazzi - Ematologia
Lecce, Italy
ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano
Legnano, Italy
AOU G. Martino - U.O.C. Ematologia
Messina, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
IEO Istitito Europeo di Oncologia - Divisione Ematoncologia
Milan, Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia
Milan, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia
Modena, Italy
AOU Maggiore della Caritа di Novara - SCDU Ematologia
Novara, Italy
AOU di Padova - Ematologia
Padua, Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padua, Italy
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani, Italy
AOU Policlinico Giaccone - Ematologia
Palermo, Italy
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, Italy
Ospedale Guglielmo da Saliceto - U.O.Ematologia
Piacenza, Italy
AOU Pisana - U.O. Ematologia
Pisa, Italy
A.O.R. "San Carlo" - U.O. Ematologia
Potenza, Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini, Italy
AO Sant'Andrea - Ematologia
Roma, Italy
Ospedale S. Eugenio - UOC Ematologia
Roma, Italy
Policlinico Tor Vergata - Ematologia
Roma, Italy
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, Italy
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano, Italy
AOU di Sassari - Ematologia
Sassari, Italy
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
Ospedale Ca Foncello - S.C di Ematologia
Treviso, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Minoia, MD
Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
July 6, 2023
Study Start
February 26, 2024
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share