Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia

Overview

The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia

Full Title of Study: “Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2020

Detailed Description

Elderly cancer incidence increases exponentially with advancing age. However, elderly patients are largely underrepresented in cancer treatment trials. The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision. It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.

Interventions

  • Other: geriatric intervention
    • Geriatric intervention

Arms, Groups and Cohorts

  • Group A : control group
    • Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions) and QoL EORTC Q30 (Quality Qf Life with 30 Questions) for patients with G8 score > 14/17
  • Group B : geriatric intervention group
    • Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients) and QoL (Quality Qf Life) EORTC Q30 for patients with G8 score ≤14/17 ( in this arm there is two groups : patient who received geriatric intervention before treatment initiation (group A) and group of patient did not received geriatric intervention before treatment initiation( group B))

Clinical Trial Outcome Measures

Primary Measures

  • Level of quality of life
    • Time Frame: 6 months
    • Level of quality of life will be measured with the QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions)
  • Level of quality of life
    • Time Frame: 6 months
    • Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions)

Secondary Measures

  • number of hospitalizations
    • Time Frame: 6 months
    • number of hospitalizations will be reported
  • Duration of hospitalizations
    • Time Frame: 6 months
    • Duration of hospitalizations will be reported in hours
  • Number of toxicities ( grade 3 and 4)
    • Time Frame: 6 months
    • Number of toxicities (grade 3 and 4) will be reported according to the CTCAE v4.0 (Common Terminology Criteria for Adverse Events)

Participating in This Clinical Trial

Inclusion Criteria

  • Patient with solid metastatic neoplasia
  • 75 years old or more
  • Men or women
  • ECOG between 0 and 3
  • Patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy)

Exclusion Criteria

  • ECOG 4
  • Localized cancer
  • Patients already included in a study witch could modify quality of life
  • Patient unable to give their consent

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Institut de Cancérologie de la Loire
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Blandine De Lavigerie, MD, Principal Investigator, Institut de Cancérologie Lucien Neuwirth
  • Overall Contact(s)
    • Blandine De Lavigerie, MD, 04 77 91 61 36, Blandine.DELAVIGERIE@icloire.fr

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