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

NCT ID: NCT04478916

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2022-05-31

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.

Conditions

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Hematologic Malignancies Solid Tumor Elderly Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Geriatric evaluation Group

Geriatric evaluation of the proportion of elderly patients in which the treatment is modified based on the complete geriatric assessment (CGA)

No interventions assigned to this group

Control Group

No interventions assigned to this group

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lorenza Scotti

OTHER

Sponsor Role lead

Responsible Party

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Lorenza Scotti

Statistician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Prof. Alessandra Gennari

Role: PRINCIPAL_INVESTIGATOR

Department of Translational Medicine, Università del Piemonte Orientale

Locations

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Università del Piemonte Orientale - Azienda Ospedliero-Universitaria Maggiore della Carita'

Novara, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Prof. Alessandra Gennari

Role: CONTACT

+39 0321 3732292

Facility Contacts

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Prof. Alessandra Gennari

Role: primary

+39 0321 3732292

References

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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.

Reference Type DERIVED
PMID: 34011271 (View on PubMed)

Other Identifiers

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ONCO-AGING

Identifier Type: -

Identifier Source: org_study_id

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