Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

Classical Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934084
• Other study ID #: FIL_Lymphoma-SCP
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: December 2023
• Source: Fondazione Italiana Linfomi - ETS
• Contact: Uffici Studi FIL
• Phone: 0599769918
• Email: startup[@]filinf.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 10 years).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 552
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Classical Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Intervention

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.

Locations

Country	Name	City	State
Italy	Ancona - AOU Ospedali Riuniti - Clinica di Ematologia	Ancona
Italy	Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati	Aviano
Italy	Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare	Bari
Italy	Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia	Barletta
Italy	Ospedale S. Martino - UOC Oncologia	Belluno
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 - Unit? funzionale di Ematologia	Firenze
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	Milano
Italy	IEO Istitito Europeo di Oncologia - Divisione Ematoncologia	Milano
Italy	Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia	Milano
Italy	Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia	Modena
Italy	AOU Maggiore della Carit? di Novara - SCDU Ematologia	Novara
Italy	AOU di Padova - Ematologia	Padova
Italy	I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From study start up to 30 months
Secondary	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.	From study start up to 30 months
Secondary	Overall survival (OS)	Overall survival, the percentage of patients alive of the cohort	From study start up to 30 months
Secondary	Frequencies of chronic fatigue (FAS);	The number of times chronic fatigue is recorded in the cohort of patients	From study start up to 30 months
Secondary	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.	From study start up to 30 months
Secondary	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.	From study start up to 30 months
Secondary	Metabolic outcomes - diabetes	Number of patients of the cohort with diabetes	From study start up to 30 months
Secondary	Frequency cardiovascular disease	The number of times cardiovascular disease is observed in the cohort of patients	From study start up to 30 months
Secondary	Compliance to screening for secondary cancers and vaccination	The number of times patients undergo screening and prevention for secondary cancers	From study start up to 30 months
Secondary	Frequency others comorbidity	The number of times others comorbidities are observed in the cohort of patients	From study start up to 30 months
Secondary	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).	From study start up to 30 months
Secondary	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.	From study start up to 30 months
Secondary	Measure of hand grip muscle strength	This end point will be measured through the use of the hand-grip dynamometer	From study start up to 30 months
Secondary	Frequencies of negative Life-Style factors	Number of negative Life-Style factors associated with cardiotoxicity and metabolic syndrome.	From study start up to 30 months
Secondary	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	From study start up to 30 months