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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
170
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.
Supportive care will be delivered according to local clinical practice
Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica
Ancona, Italy
A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
Aviano, Italy
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari, Italy
A.S.S.T. Spedali Civili - S.C. Ematologia
Brescia, Italy
A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO
Cagliari, Italy
A.O.U. Careggi - S.O.D. Ematologia
Florence, Italy
A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan, Italy
I.R.C.C.S. Fondazione Cà Granda Ospedale Maggiore Policlinico - S.C. Ematologia
Milan, Italy
I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia
Monza, Italy
...and 14 more locations
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").
Time frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
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").
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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,
Time frame: 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.
Time frame: 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
Time frame: 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")
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the beginning up to the end of study (up to 36 months)
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