Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

Sponsor

Fondazione Italiana Linfomi - ETS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05934084

Collaborator

(none)

552

Enrollment

Locations

Arms

30.1

Anticipated Duration (Months)

13.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Classical Hodgkin Lymphoma Diffuse Large B Cell Lymphoma (DLBCL) Primary Mediastinal Large B-cell Lymphoma (PMBCL)	Behavioral: Lifestyles Implemented-Survivorship Care Plan (LS-SCP)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

552 participants

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.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)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Arm (C) 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: Experimental Arm (E) Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months.	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.

Arm

Intervention/Treatment

No Intervention: Control Arm (C)

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: Experimental Arm (E)

Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months.

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.

Outcome Measures

Primary Outcome Measures

Global quality of life [From study start up to 30 months]
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.

Secondary Outcome Measures

Impact of health on an individual's everyday life [From study start up to 30 months]
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.
Changes in psychosocial well-being [From study start up to 30 months]
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.
Overall survival (OS) [From study start up to 30 months]
Overall survival, the percentage of patients alive of the cohort
Frequencies of chronic fatigue (FAS); [From study start up to 30 months]
The number of times chronic fatigue is recorded in the cohort of patients
Cognitive function [From study start up to 30 months]
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.
Metabolic outcomes -BMI [From study start up to 30 months]
Body Mass Index (BMI) will be evaluated for every patient. Weight and height will be combined to report BMI in kg/m^2.
Metabolic outcomes - diabetes [From study start up to 30 months]
Number of patients of the cohort with diabetes
Frequency cardiovascular disease [From study start up to 30 months]
The number of times cardiovascular disease is observed in the cohort of patients
Compliance to screening for secondary cancers and vaccination [From study start up to 30 months]
The number of times patients undergo screening and prevention for secondary cancers
Frequency others comorbidity [From study start up to 30 months]
The number of times others comorbidities are observed in the cohort of patients
Adherence to healthy lifestyles - healthy diet [From study start up to 30 months]
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).
Adherence to healthy lifestyles - Physical Activity [From study start up to 30 months]
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.
Measure of hand grip muscle strength [From study start up to 30 months]
This end point will be measured through the use of the hand-grip dynamometer
Frequencies of negative Life-Style factors [From study start up to 30 months]
Number of negative Life-Style factors associated with cardiotoxicity and metabolic syndrome.
Frequency of compliance between planned and effective follow-up via LS-SCP. [From study start up to 30 months]
Number of times the plan prescribed by the LS-SCP is adhered to correctly in the cohort of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Ancona - AOU Ospedali Riuniti - Clinica di Ematologia	Ancona	Italy
2	Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati	Aviano	Italy
3	Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare	Bari	Italy
4	Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia	Barletta	Italy
5	Ospedale S. Martino - UOC Oncologia	Belluno	Italy
6	Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.	Bolzano	Italy
7	ASST Spedali Civili di Brescia - Ematologia	Brescia	Italy
8	Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo	Brindisi	Italy
9	PO Sant'Elia ASP Caltanisetta - UOC Ematologia	Caltanissetta	Italy
10	Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia	Catania	Italy
11	Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia	Catania	Italy
12	Ospedale Generale di zona Valduce - Oncoematologia	Como	Italy
13	Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia	Firenze	Italy
14	Ospedale Vito Fazzi - Ematologia	Lecce	Italy
15	ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano	Legnano	Italy
16	AOU G. Martino - U.O.C. Ematologia	Messina	Italy
17	ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia	Milano	Italy
18	IEO Istitito Europeo di Oncologia - Divisione Ematoncologia	Milano	Italy
19	Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia	Milano	Italy
20	Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia	Modena	Italy
21	AOU Maggiore della Caritа di Novara - SCDU Ematologia	Novara	Italy
22	AOU di Padova - Ematologia	Padova	Italy
23	I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1	Padova	Italy
24	Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia	Pagani	Italy
25	AOU Policlinico Giaccone - Ematologia	Palermo	Italy
26	P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi	Pescara	Italy
27	Ospedale Guglielmo da Saliceto - U.O.Ematologia	Piacenza	Italy
28	AOU Pisana - U.O. Ematologia	Pisa	Italy
29	A.O.R. "San Carlo" - U.O. Ematologia	Potenza	Italy
30	Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia	Reggio Emilia	Italy
31	Ospedale degli Infermi di Rimini - U.O. di Ematologia	Rimini	Italy
32	AO Sant'Andrea - Ematologia	Roma	Italy
33	Ospedale S. Eugenio - UOC Ematologia	Roma	Italy
34	Policlinico Tor Vergata - Ematologia	Roma	Italy
35	Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare	Roma	Italy
36	Istituto Clinico Humanitas - U.O. Ematologia	Rozzano	Italy
37	AOU di Sassari - Ematologia	Sassari	Italy
38	Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico	Sassuolo	Italy
39	A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria	Torino	Italy
40	Ospedale Ca Foncello - S.C di Ematologia	Treviso	Italy