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
Abstract Background Age is considered as one of the most important risk-factor for many types of solid and hematological cancers, as their incidence increases with age in parallel to the ever-growing elderly population. Moreover, cancer incidence is constantly increasing as a consequence of the incr...
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2021-05-01
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Series: | BMC Geriatrics |
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Online Access: | https://doi.org/10.1186/s12877-021-02237-3 |
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language |
English |
format |
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DOAJ |
author |
Abdurraouf Mokhtar Mahmoud Federica Biello Paola Maria Maggiora Riccardo Bruna Giovanni Burrafato Miriam Cappelli Feba Varughese Veronica Martini Francesca Platini Clara Deambrogi Andrea Patriarca Maura Nicolosi Ajay ram Vachanaram Carla Pisani Eleonora Ferrara Elvira Catania Danila Azzolina Francesco Barone-Adesi Marco Krengli Gianluca Gaidano Alessandra Gennari |
spellingShingle |
Abdurraouf Mokhtar Mahmoud Federica Biello Paola Maria Maggiora Riccardo Bruna Giovanni Burrafato Miriam Cappelli Feba Varughese Veronica Martini Francesca Platini Clara Deambrogi Andrea Patriarca Maura Nicolosi Ajay ram Vachanaram Carla Pisani Eleonora Ferrara Elvira Catania Danila Azzolina Francesco Barone-Adesi Marco Krengli Gianluca Gaidano Alessandra Gennari 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 Geriatrics Comprehensive geriatric assessment (CGA) G8 questionnaire Quality of Life (QoL) Cell senescence |
author_facet |
Abdurraouf Mokhtar Mahmoud Federica Biello Paola Maria Maggiora Riccardo Bruna Giovanni Burrafato Miriam Cappelli Feba Varughese Veronica Martini Francesca Platini Clara Deambrogi Andrea Patriarca Maura Nicolosi Ajay ram Vachanaram Carla Pisani Eleonora Ferrara Elvira Catania Danila Azzolina Francesco Barone-Adesi Marco Krengli Gianluca Gaidano Alessandra Gennari |
author_sort |
Abdurraouf Mokhtar Mahmoud |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
BMC Geriatrics |
issn |
1471-2318 |
publishDate |
2021-05-01 |
description |
Abstract Background Age is considered as one of the most important risk-factor for many types of solid and hematological cancers, as their incidence increases with age in parallel to the ever-growing elderly population. Moreover, cancer incidence is constantly increasing as a consequence of the increase in life expectancy that favors the process of cellular senescence. Geriatric assessment has been increasingly recognized as predictive and prognostic instrument to detect frailty in older adults with cancer. In particular, the G8 score is a simple and reproducible instrument to identify elderly patients who should undergo full geriatric evaluation. Due to their frailty, elderly patients may be often under-treated and a therapeutic choice based also on a comprehensive geriatric assessment (CGA) is recommended. With these premises, we aim to test the impact of the CGA based interventions on the quality of life (QoL) of frail elderly onco-hematological patients, identified by the G8 screening, candidate for innovative target directed drugs or treatments including the combination of radiotherapy and chemotherapy (RT + CT). Methods Patients aged > 65 years, candidate to target directed agents or to RT + CT treatments are screened for frailty by the G8 test; those patients classified as frail (G8 ≤ 14) are randomized to receive a CGA at baseline or to conventional care. The primary endpoint is QoL, assessed by EORTC QLQ-C30C. As collateral biological study, the potential prognostic/predictive role of T-cell senescence and myeloid derived suppressor cells (MDSC) are evaluated on plasma samples. Discussion This trial will contribute to define the impact of CGA on the management of frail elderly onco-hematologic patients candidate to innovative biological drugs or to integrated schedules with the association of RT + CT. Furthermore, the use of plasma samples to assess the potential prognostic value of imbalance of immune-competent cells is expected to contribute to the individualized care of elderly patients, resulting into a fine tuning of the therapeutic strategies. Trial registration ClinicalTrials.gov ID: NCT04478916 . registered July 21, 2020 – retrospectively registered. |
topic |
Comprehensive geriatric assessment (CGA) G8 questionnaire Quality of Life (QoL) Cell senescence |
url |
https://doi.org/10.1186/s12877-021-02237-3 |
work_keys_str_mv |
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doaj-97ccbb1f1a4a4cc1b0e7fd54a253577c2021-05-23T11:10:59ZengBMCBMC Geriatrics1471-23182021-05-012111910.1186/s12877-021-02237-3A 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 studyAbdurraouf Mokhtar Mahmoud0Federica Biello1Paola Maria Maggiora2Riccardo Bruna3Giovanni Burrafato4Miriam Cappelli5Feba Varughese6Veronica Martini7Francesca Platini8Clara Deambrogi9Andrea Patriarca10Maura Nicolosi11Ajay ram Vachanaram12Carla Pisani13Eleonora Ferrara14Elvira Catania15Danila Azzolina16Francesco Barone-Adesi17Marco Krengli18Gianluca Gaidano19Alessandra Gennari20Division of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDepartment of Palliative Care, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Radiation Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Radiation Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDepartment of Palliative Care, Azienda Ospedaliero-Universitaria Maggiore della CaritàUnit of Medical Statistics, Department of Translational Medicine, University of Eastern Piedmont and CPO PiemonteUnit of Epidemiology, Department of Translational Medicine, University of Eastern PiedmontDivision of Radiation Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàDivision of Oncology, Department of Translational Medicine, University of Eastern Piedmont, Azienda Ospedaliero-Universitaria Maggiore della CaritàAbstract Background Age is considered as one of the most important risk-factor for many types of solid and hematological cancers, as their incidence increases with age in parallel to the ever-growing elderly population. Moreover, cancer incidence is constantly increasing as a consequence of the increase in life expectancy that favors the process of cellular senescence. Geriatric assessment has been increasingly recognized as predictive and prognostic instrument to detect frailty in older adults with cancer. In particular, the G8 score is a simple and reproducible instrument to identify elderly patients who should undergo full geriatric evaluation. Due to their frailty, elderly patients may be often under-treated and a therapeutic choice based also on a comprehensive geriatric assessment (CGA) is recommended. With these premises, we aim to test the impact of the CGA based interventions on the quality of life (QoL) of frail elderly onco-hematological patients, identified by the G8 screening, candidate for innovative target directed drugs or treatments including the combination of radiotherapy and chemotherapy (RT + CT). Methods Patients aged > 65 years, candidate to target directed agents or to RT + CT treatments are screened for frailty by the G8 test; those patients classified as frail (G8 ≤ 14) are randomized to receive a CGA at baseline or to conventional care. The primary endpoint is QoL, assessed by EORTC QLQ-C30C. As collateral biological study, the potential prognostic/predictive role of T-cell senescence and myeloid derived suppressor cells (MDSC) are evaluated on plasma samples. Discussion This trial will contribute to define the impact of CGA on the management of frail elderly onco-hematologic patients candidate to innovative biological drugs or to integrated schedules with the association of RT + CT. Furthermore, the use of plasma samples to assess the potential prognostic value of imbalance of immune-competent cells is expected to contribute to the individualized care of elderly patients, resulting into a fine tuning of the therapeutic strategies. Trial registration ClinicalTrials.gov ID: NCT04478916 . registered July 21, 2020 – retrospectively registered.https://doi.org/10.1186/s12877-021-02237-3Comprehensive geriatric assessment (CGA)G8 questionnaireQuality of Life (QoL)Cell senescence |