Impact of the Comprehensive Geriatric Assessment on the Quality of Life OF Elderly Patients

Study Overview
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Brief Summary
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Impact of the Comprehensive Geriatric Assessment on the Quality of Life of elderly onco-hematologic patients' candidates for complex antitumoral therapies: clinical and biological correlatives

Detailed Description
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The screenings for the next 2 decades indicate an exponential increase in the incidence of neoplastic diseases in the elderly population. In order to successfully balance effectiveness and low toxicity of immunochemotherapy, a treatment personalisation based on an objective evaluation of fitness is therefore needed. The use of geriatric screening is a first step to rationalize decisions in this regard, the G8 tool has demonstrated the ability to identify patients and mostly to objectively separate elderly fragile patients from those who are fit. In that consideration, the individualization of the anticancer treatment based on a Comprehensive Geriatric Assessment (CGA) is desirable in elderly fragile patients with solid or haematological malignancy. Cancer mortality is constantly increasing after 65 years and the consequent increase in life expectancy favour the processes of cellular senescence. In this context G8 fragility assessment will take place in the screening test and by using the EORTC QLQ-C30C questionnaire to assess quality of life (QoL). The evaluation of senescent cells will be done by real-time PCR. Our aims are i) to evaluate the impact of the CGA on the QoL of elderly onco-haematological patients, candidates for complex therapies, that resulted as fragile at the G8 geriatric screening and ii) to evaluate the senescent cells in the peripheral blood of the patients enrolled in the study. The study is expected to contribute to precision medicine management of elderly patients and refine the therapeutic stratifications.

Official Title
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Impact of the Comprehensive Geriatric Assessment on the Quality of Life of Elderly Onco-hematologic Patients' Candidates for Complex Antitumoral Therapies: Clinical and Biological Correlatives

Conditions
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Hematologic Malignancies, Solid Tumor, Elderly Patients

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 65 years Diagnosis of solid or hematologic cancer Patients who are candidates for a first line therapy for advanced disease to be treated with biological target drugs, or candidates for integrated radiotherapy Patient with G8 scores ≤ 14/17 Exclusion Criteria: Patients aged less than 65 years Patients who have received or currently in treatment for solid or hematologic cancer Patient with G8 scores more than 14/17

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Geriatric evaluation Group<br>Geriatric evaluation of the proportion of elderly patients in which the treatment is modified based on the complete geriatric assessment (CGA) | |
| Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL) | To assess the impact of the inclusion of the CGA on the quality of life (QOL) of the elderly onco-hematology patient that result frail in the geriatric screening (G8), compared to the clinical practice that does not include the CGA | 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL) | Part of patients receiving radiotherapy will be randomised to be evaluated using CGA compared to control group, the CGA assessment will be done using the status of ADL, IADL, QOL, MNA, SVI, GDS, CIRS, TC, MMSE, CDT, MOCA, RFI, VMD, at baseline and would be re-evaluated after every 6 month and If necessary, an onco-geriatric follow-up will be carried out, for the re-evaluation and further correction of the areas of fragility. A description of the changes of the above scales would also be recorded for the patients | 12 months after randomization (G8; at screening and every 6 months, QOL; at baseline and every 3 months, CGA; at baseline and every 6 months) | 
| Progression free survival (PFS) | Progression Free Survival (PFS): From the date of diagnosis to the last follow-up, or to one of the following events: disease progression during treatment, or relapse, or death from any cause | From randomisation (December 2019-December 2022) | 
| Failure Free Survival (FFS) | Failure Free Survival (FFS). From the date of diagnosis to to any treatment failure including disease progression, or discontinuation of treatment for any reason, (eg, disease progression, toxicity, patient preference, initiation of new treatment), or death from any cause | From randomisation (December 2019-December 2022) | 
| Occurrence of dose reductions | Data will be collected by reviewing patients medical charts | From randomisation through study completion, an average of 1 year | 
| Overall Survival (OS) | From the date of diagnosis to the last patient last visit | From randomisation (December 2019-December 2022) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onco-hematologic diseases, Comprehensive Geriatric Assessment (CGA), Screening tool G8, Geriatric Medicine, Precision Medicine, Senescence