Clinical trial NCT04478916: Impact of the Comprehensive Geriatric Assessment on the Quality of Life OF Elderly Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Malignancies
Solid Tumor
Elderly Patients
Keywords: Onco-hematologic diseases
Comprehensive Geriatric Assessment (CGA)
Screening tool G8
Geriatric Medicine
Precision Medicine
Senescence
Lead sponsor: University of Eastern Piedmont
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the present study, only patients aged ≥ 65 years, with diagnosis of solid or hematologic cancer are eligible. Main inclusion criteria are two; i) patients who are candidates for a first line therapy for advanced disease to be treated with biological target drugs, or candidates for integrated radiotherapy; ii) patient with G8 scores ≤ 14/17

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL)
timeFrame: 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 outcomes:
measure: Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL)
timeFrame: 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)
measure: Progression free survival (PFS)
timeFrame: From randomisation (December 2019-December 2022)
measure: Failure Free Survival (FFS)
timeFrame: From randomisation (December 2019-December 2022)
measure: Occurrence of dose reductions
timeFrame: From randomisation through study completion, an average of 1 year
measure: Overall Survival (OS)
timeFrame: From randomisation (December 2019-December 2022)
Other outcomes:
measure: Senescent cells role in interfering with the planned therapy
timeFrame: 2019-From randomisation until 12 months or until disease progression
Locations:
city: Novara
country: Italy
facility: Università del Piemonte Orientale - Azienda Ospedliero-Universitaria Maggiore della Carita'
Study officials:
affiliation: Department of Translational Medicine, Università del Piemonte Orientale
name: Prof. Alessandra Gennari
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahmoud AM, Biello F, Maggiora PM, Bruna R, Burrafato G, Cappelli M, Varughese F, Martini V, Platini F, Deambrogi C, Patriarca A, Nicolosi M, Vachanaram AR, Pisani C, Ferrara E, Catania E, Azzolina D, Barone-Adesi F, Krengli M, Gaidano G, Gennari A. A randomized clinical study on the impact of Comprehensive Geriatric Assessment (CGA) based interventions on the quality of life of elderly, frail, onco-hematologic patients candidate to anticancer therapy: protocol of the ONCO-Aging study. BMC Geriatr. 2021 May 19;21(1):320. doi: 10.1186/s12877-021-02237-3.