Impact of the Comprehensive Geriatric Assessment on the Quality of Life OF Elderly Patients (ONCO-AGING)

July 23, 2020 updated by: Lorenza Scotti

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

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 Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Recruiting
        • Università del Piemonte Orientale - Azienda Ospedliero-Universitaria Maggiore della Carita'
        • Contact:
        • Principal Investigator:
          • Prof. Alessandra Gennari
        • Principal Investigator:
          • Prof. Gianluca Gaidano
        • Principal Investigator:
          • Prof. Marco Krengli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients received planned treatment and CGA evaluated with improvement of good quality of life (QOL)
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients received radiotherapy planned and CGA evaluated with improvement of good quality of life (QOL)
Time Frame: 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)
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)
Progression free survival (PFS)
Time Frame: From randomisation (December 2019-December 2022)
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)
Failure Free Survival (FFS)
Time Frame: From randomisation (December 2019-December 2022)
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)
Occurrence of dose reductions
Time Frame: From randomisation through study completion, an average of 1 year
Data will be collected by reviewing patients medical charts
From randomisation through study completion, an average of 1 year
Overall Survival (OS)
Time Frame: From randomisation (December 2019-December 2022)
From the date of diagnosis to the last patient last visit
From randomisation (December 2019-December 2022)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Senescent cells role in interfering with the planned therapy
Time Frame: 2019-From randomisation until 12 months or until disease progression
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lorenza Scotti

Investigators

  • Principal Investigator: Prof. Alessandra Gennari, Department of Translational Medicine, Università del Piemonte Orientale

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCO-AGING

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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