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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm (C) | No Intervention | 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 Arm (E) | Experimental | Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity indication) for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyles Implemented-Survivorship Care Plan (LS-SCP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in psychosocial well-being |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | 0599769918 | startup@filinf.it | |
| Uffici Studi FIL | Contact | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Carla Minoia, MD | Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ancona - AOU Ospedali Riuniti - Clinica di Ematologia | Recruiting | Ancona | Ancona | Italy |
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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.
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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 |
| Overall survival (OS) | Overall survival, the percentage of patients alive of the cohort | From study start up to 30 months |
| 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 |
| 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 |
| 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 |
| Metabolic outcomes - diabetes | Number of patients of the cohort with diabetes | From study start up to 30 months |
| Frequency cardiovascular disease | The number of times cardiovascular disease is observed in the cohort of patients | From study start up to 30 months |
| 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 |
| Frequency others comorbidity | The number of times others comorbidities are observed in the cohort of patients | From study start up to 30 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati | Recruiting | Aviano | Aviano | Italy |
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| Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare | Recruiting | Bari | Bari | Italy |
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| Ospedale S. Martino - UOC Oncologia | Not yet recruiting | Belluno | Belluno | Italy |
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| Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia | Recruiting | Barletta | Italy |
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| Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O. | Recruiting | Bolzano | Italy |
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| ASST Spedali Civili di Brescia - Ematologia | Recruiting | Brescia | Italy |
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| Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo | Recruiting | Brindisi | Italy |
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| PO Sant'Elia ASP Caltanisetta - UOC Ematologia | Not yet recruiting | Caltanissetta | Italy |
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| Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia | Recruiting | Catania | Italy |
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| Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia | Recruiting | Catania | Italy |
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| Ospedale Generale di zona Valduce - Oncoematologia | Recruiting | Como | Italy |
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| Azienda Ospedaliera Universitaria Careggi - Unitа funzionale di Ematologia | Recruiting | Florence | Italy |
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| Ospedale Vito Fazzi - Ematologia | Not yet recruiting | Lecce | Italy |
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| ASST Ovest Milanese - Legnano - U.O.C. Ematologia Ospedale Civile di Legnano | Recruiting | Legnano | Italy |
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| AOU G. Martino - U.O.C. Ematologia | Not yet recruiting | Messina | Italy |
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| ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia | Recruiting | Milan | Italy |
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| IEO Istitito Europeo di Oncologia - Divisione Ematoncologia | Recruiting | Milan | Italy |
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| Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia | Recruiting | Milan | Italy |
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| Azienda Ospedaliero-Universitaria Policlinico di Modena - U.O. Oncologia | Recruiting | Modena | Italy |
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| AOU Maggiore della Caritа di Novara - SCDU Ematologia | Not yet recruiting | Novara | Italy |
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| AOU di Padova - Ematologia | Recruiting | Padova | Italy |
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| I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 | Recruiting | Padova | Italy |
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| Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia | Recruiting | Pagani | Italy |
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| AOU Policlinico Giaccone - Ematologia | Recruiting | Palermo | Italy |
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| P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi | Recruiting | Pescara | Italy |
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| Ospedale Guglielmo da Saliceto - U.O.Ematologia | Recruiting | Piacenza | Italy |
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| AOU Pisana - U.O. Ematologia | Not yet recruiting | Pisa | Italy |
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| A.O.R. "San Carlo" - U.O. Ematologia | Not yet recruiting | Potenza | Italy |
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| Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia | Recruiting | Reggio Emilia | Italy |
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| Ospedale degli Infermi di Rimini - U.O. di Ematologia | Recruiting | Rimini | Italy |
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| AO Sant'Andrea - Ematologia | Recruiting | Roma | Italy |
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| Ospedale S. Eugenio - UOC Ematologia | Recruiting | Roma | Italy |
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| Policlinico Tor Vergata - Ematologia | Not yet recruiting | Roma | Italy |
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| Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare | Recruiting | Roma | Italy |
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| Istituto Clinico Humanitas - U.O. Ematologia | Withdrawn | Rozzano | Italy |
| AOU di Sassari - Ematologia | Not yet recruiting | Sassari | Italy |
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| Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico | Recruiting | Sassuolo | Italy |
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| A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria | Recruiting | Torino | Italy |
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| Ospedale Ca Foncello - S.C di Ematologia | Recruiting | Treviso | Italy |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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