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

NCT04478916 | Unknown

• 1 other identifier: ONCO-AGING
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

Hematologic Malignancies; Solid Tumor; Elderly Patients

Keywords

Onco-hematologic diseases; Comprehensive Geriatric Assessment (CGA); Screening tool G8; Geriatric Medicine; Precision Medicine; Senescence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL)

  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)

  From randomisation (December 2019-December 2022)

• Failure Free Survival (FFS)

  From randomisation (December 2019-December 2022)

• Occurrence of dose reductions

  From randomisation through study completion, an average of 1 year

• Overall Survival (OS)

  From randomisation (December 2019-December 2022)

Other Outcomes (1)

• Senescent cells role in interfering with the planned therapy

  2019-From randomisation until 12 months or until disease progression

Study Arms (2)

Geriatric evaluation Group

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

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lorenza Scotti: lead

Study Sites (1)

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

Novara, 28100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 34011271 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The study is designed to evaluate the senescent cells and MDSC; in the peripheral blood of the patients enrolled in the project in 2 time-points: first on basal line (t = 0) and after 12 months or in disease progression. Blood samples (10 ml whole blood) will be collected in Vacutainer EDTA tubes.

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Prof. Alessandra Gennari

  Department of Translational Medicine, Università del Piemonte Orientale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Alessandra Gennari

CONTACT

+39 0321 3732292; alessandra.gennari@med.uniupo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Statistician

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: December 18, 2019
• Primary Completion: September 1, 2021
• Study Completion: May 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

IT (1)