Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)

September 28, 2021 updated by: Poitiers University Hospital

Place of Comprehensive Geriatric Assessment (CGA) in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter): Comparison Between CGA Before Surgery (Strategy A) vs. After Surgery (Strategy B)

The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered.

Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery.

The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

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

  • France
      • Angouleme, France, 16959
        • Hospital center
      • Bressuire, France, 79302
        • Hospital center
      • La Rochelle, France, 17019
        • Hospital center
      • Niort, France, 79021
        • Hospital center
      • Poitiers, France, 86000
        • University Hospital Center
      • Saintes, France, 17108
        • Hospital center

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

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • First breast cancer localized, indication of surgery
  • Onco-geriatric filter (FOG) >= 1 ou < 4

Exclusion Criteria:

  • Male, less of 75 years old
  • Contraindication of surgery
  • Breast cancer with metastasis
  • Onco-geriatric filter (FOG) = 0 or 4

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Strategy A
Comprehensive Geriatric Assessment before the surgery of breast
Behavioral: Medical consultation for a Standardized Geriatric Evaluation
OTHER: Strategy B
Comprehensive Geriatric Assessment after the surgery of breast
Behavioral: Medical consultation for a Standardized Geriatric Evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of patients
Time Frame: 5 years
Questionnary EORTC QLQ - BR33
5 years
Patient satisfaction with their management
Time Frame: 5 years
Questionnary REPERES 60 - Consumer Satisfaction Survey
5 years
Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard
Time Frame: 5 years
5 years
Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Time Frame: 5 years
5 years
Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

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)

January 30, 2014

Primary Completion (ACTUAL)

July 31, 2021

Study Completion (ANTICIPATED)

July 31, 2025

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYNECO ONCOGER

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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