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

Solid Tumor Clinical Trial

— ONCO-AGING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478916
• Other study ID #: ONCO-AGING
• Status: Recruiting
• Start date: December 18, 2019
• Est. completion date: May 2022

Study information

• Verified date: July 2020
• Source: University of Eastern Piedmont
• Contact: Prof. Alessandra Gennari
• Phone: +39 0321 3732292
• Email: alessandra.gennari[@]med.uniupo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: May 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly Patients
• Hematologic Malignancies
• Hematologic Neoplasms
• Solid Tumor

Locations

Country	Name	City	State
Italy	Università del Piemonte Orientale - Azienda Ospedliero-Universitaria Maggiore della Carita'	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Lorenza Scotti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Senescent cells role in interfering with the planned therapy	Senescent cells levels and their role in interfering with the planned therapy and the outcome of disease prognosis, PFS, OS. and the correlation between senescent cells level with the results of patients QOL, CGA and G8	2019-From randomisation until 12 months or until disease progression
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Occurrence of dose reductions	Data will be collected by reviewing patients medical charts	From randomisation through study completion, an average of 1 year
Secondary	Overall Survival (OS)	From the date of diagnosis to the last patient last visit	From randomisation (December 2019-December 2022)