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.
Diagnosis of DLBCL or Follicular Lymphoma (FL) grade IIIB.
Age ≥ 70 years.
UNFIT or FRAIL status according to sGA evaluated by the onco-hematologist at baseline.
Patients eligible to a curative intent standard first line chemoimmunotherapy.
Patients not meeting at least one of the inclusion criteria listed above.
Refuse to sign a written informed consent.
Parallel
Geriatric-guided supportive care
Other interventionStructured 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
Other interventionSupportive care will be delivered according to local clinical practice
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").
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").
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
To compare eventual dose reductions of therapeutic treatments between groups.
Chemoimmunotherapy dose reductions rate stratified according to therapeutic choices and delivered dose intensity
To evaluate the prognostic impact of sGA on overall survival (OS)
Overall survival evaluation stratified according to sGA
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