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The aim of this multicenter, non-randomized, cluster controlled trial study is to evaluate the impact of a geriatric-guided approach with a pro-active rehabilitative/nutritional plan for elderly unfit/frail DLBCL patients eligible for receiving chemoimmunotherapy according to the sGA, versus a conventional approach with onco-hematological treatment alone.
A key innovation element of this project is to use a geriatric-guided approach to improve the global management of all frailty aspects (nutritional, functional, cognitive, social), chasing a better tolerance and completion rate of treatment, tailoring safety and efficacy of therapies in unfit/frail DLBCL patients.
This study may lead to a personalized approach for elderly DLBCL patients, taking into account a multidisciplinary and fully-integrated program, with the primary aim of improving the quality of life of patients and their families.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geriatric-guided supportive care | Experimental | Patients will be treated for lymphoma according to standard clinical practice. Patients will receive a geriatric-guided supportive care with structured geriatric consultation, along with a nutritional and physiotherapy evaluation, before treatment initiation and with subsequent follow-up assessments aimed at optimizing comorbidity management, nutritional and functional status, along with treatment tolerance. |
|
| Conventional supportive care | Active Comparator | Patients will be treated for lymphoma according to standard clinical practice. Patients will receive supportive care according to standard clinical practice without systematic geriatric input. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatric-guided supportive care | Other | Structured geriatric consultation, along with a nutritional and physiotherapy evaluation, before treatment initiation and with subsequent follow-up assessments aimed at optimizing comorbidity management, nutritional and functional status, along with treatment tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether a geriatric-guided approach improves health-related quality of life (HRQL) in elderly patients with DLBCL eligible for first-line chemoimmunotherapy, compared to a conventional approach. | Change in the Global Health Status/QoL score of the EORTC Quality of Life Core 30 From baseline to end of treatment (6 months after enrollment). EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much"). | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess changes in the functioning scales and symptom scales of the EORTC QLQ-C30 performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach) | Change from baseline in the functioning scales (physical, role, emotional, cognitive, social) and symptom scales (e.g., fatigue, pain, nausea/vomiting) of the EORTC QLQ-C30 at 3, 6, and 12 months. EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | +390131033153 | startup@filinf.it | |
| Uffici Studi FIL | Contact | +390599769913 | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Benedetta Sordi, MD | A.O.U. Careggi di Firenze - S.O.D. Ematologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica | Ancona | Italy |
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non-randomized cluster controlled
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| Conventional supportive care | Other | Supportive care will be delivered according to local clinical practice |
|
| From the beginning up to the end of study (up to 36 months) |
| To assess changes in simplified Geriatric Assessment (sGA) performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach) | Change in simplified Geriatric Assessment (sGA) classes assessed at baseline, 3, 6, and 12 months. sGA scale: fit, unfit, frail | From the beginning up to the end of study (up to 36 months) |
| To compare eventual dose reductions of therapeutic treatments between groups. | Chemoimmunotherapy dose reductions rate stratified according to therapeutic choices and delivered dose intensity | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) |
| To evaluate the prognostic impact of sGA on overall survival (OS) | Overall survival evaluation stratified according to sGA | From the beginning up to the end of study (up to 36 months) |
| To compare the treatment completion rate between groups | Rate of Treatment completion, defined as the proportion of patients who complete the planned chemoimmunotherapy without premature discontinuation. | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) |
| To assess early mortality rate (within 90 days) in the two groups. | Early mortality proportion, defined as death from any cause within 90 days of enrollment. | From the beginning of the study up to 90 days after last enrolled patient (up 27 months from study beginning) |
| To compare overall response rate (ORR) and complete response rate (CRR) between groups. | Overall Response Rate (ORR) and Complete Response Rate (CRR), assessed according to Lugano classification at end of treatment, | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) |
| To evaluate progression-free survival (PFS) and overall survival (OS) in the two groups. | Progression-Free Survival (PFS) and Overall Survival (OS), defined according to standard criteria, with time measured from date of enrollment. | From the beginning up to the end of study (up to 36 months) |
| To compare hospitalization rates between groups. | Healthcare resource utilization: Incidence of hospital admissions | From the beginning up to the end of study (up to 36 months) |
| To assess caregiver quality of life and caregiver-related outcomes measured by the CareGiver Oncology Quality of life questionnaire (CarGOQoL) at baseline, 3, 6, and 12 months in both groups. | Caregiver-reported outcomes, including caregiver Quality of Life and burden, assessed at baseline, 3, 6, and 12 months using The CareGiver Oncology Quality of life questionnaire (CarGOQoL). CarGOQoL: rank from 0 ("never/not at all") to 5 ("always/enormously") | From the beginning up to the end of study (up to 36 months) |
| To evaluate modifications in the Fried frailty index assessed only in the geriatric-guided arm (performed at baseline, 3, 6, and 12 months) and if there is a concordance between sGA and Fried score. | Change in the Fried frailty index assessed in the geriatric-guided arm, performed at baseline, 3, 6, and 12 months. Assessment if a dynamic change of fitness class is present and if it differs significantly from sGA (performed in both arms). Fried score and sGA: fit (robust), unfit (pre-frail), frail (frail). | From the beginning up to the end of study (up to 36 months) |
| To compare median hospital stay between groups. | Healthcare resource utilization: Mean duration of hospital stay (in days) | From the beginning up to the end of study (up to 36 months) |
| To compare emergency department access rate between groups. | Healthcare resource utilization: Incidence of emergency department accesses | From the beginning up to the end of study (up to 36 months) |
| To compare hospice admission rate between groups. | Healthcare resource utilization: Incidence of patients admitted to hospice during follow-up | From the beginning up to the end of study (up to 36 months) |
| To compare eventual dose delays of therapeutic treatments between groups. | Chemoimmunotherapy dose delays rate stratified according to therapeutic choices and delivered dose intensity | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) |
| To evaluate the prognostic impact of Body Mass Index (BMI) on overall survival (OS). | Overall survival evaluation stratified according to BMI value | From the beginning up to the end of study (up to 36 months) |
| To evaluate the prognostic impact of serum albumin on overall survival (OS). | Overall survival evaluation stratified according to serum albumine value | From the beginning up to the end of study (up to 36 months) |
| To evaluate the prognostic impact of caregiver availability on overall survival (OS). | Overall survival evaluation stratified according to caregiver availability | From the beginning up to the end of study (up to 36 months) |
| A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico | Avellino | Italy |
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| I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati | Aviano | Italy |
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| I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia | Bari | Italy |
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| A.S.S.T. Spedali Civili - S.C. Ematologia | Brescia | Italy |
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| A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO | Cagliari | Italy |
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| A.O.U. Careggi - S.O.D. Ematologia | Florence | Italy |
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| A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia | Milan | Italy |
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| I.R.C.C.S. Fondazione CÃ Granda Ospedale Maggiore Policlinico - S.C. Ematologia | Milan | Italy |
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| I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia | Monza | Italy |
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| I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1 | Padova | Italy |
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| A.O.U. Policlinico "Paolo Giaccone" - U.O.C. Ematologia | Palermo | Italy |
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| Azienda Ospedaliero Universitaria di Parma - S.C. Ematologia e C.T.M.O. | Parma | Italy |
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| A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti | Piacenza | Italy |
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| Azienda USL Toscana Centro - SOS Oncoematologia | Prato | Italy |
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| A.U.S.L. di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia | Ravenna | Italy |
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| A.U.S.L. I.R.C.C.S. Arcispedale S. Maria Nuova - S.C. Ematologia | Reggio Emilia | Italy |
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| Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali | Roma | Italy |
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| A.O.U. Senese - U.O.C. Ematologia | Siena | Italy |
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| A.S.L. Teramo Osp. "Giuseppe Mazzini" - U.O.S. Ematologia | Teramo | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U | Torino | Italy |
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| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia | Torino | Italy |
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| A.S.U. Friuli Centrale - Clinica Ematologica | Udine | Italy |
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| A.O.U.I. di Verona - U.O.C. Ematologia | Verona | Italy |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| 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 |
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