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

Not Applicable

Active, not recruiting

• Conditions: 75 Years Old and More; Female Breast Cancer; Surgery
• Interventions: Behavioral: Medical consultation for a Standardized Geriatric Evaluation

• Registration Number: NCT03059875
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-30
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Primary Completion: 2021-07-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strategy A	Medical consultation for a Standardized Geriatric Evaluation	Comprehensive Geriatric Assessment before the surgery of breast
Strategy B	Medical consultation for a Standardized Geriatric Evaluation	Comprehensive Geriatric Assessment after the surgery of breast

Primary Outcome Measures

Name	Time	Method
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hospital Center; 🇫🇷 La Rochelle, France

University Hospital Center; 🇫🇷 Poitiers, France

Hospital center; 🇫🇷 Saintes, France