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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Surgery, 75 Years Old and More, Female Breast Cancer

Intervention / Treatment
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* Behavioral: Medical consultation for a Standardized Geriatric Evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Strategy A<br>Comprehensive Geriatric Assessment before the surgery of breast | Behavioral: Medical consultation for a Standardized Geriatric Evaluation<br> <br> |
| Other: Strategy B<br>Comprehensive Geriatric Assessment after the surgery of breast | Behavioral: Medical consultation for a Standardized Geriatric Evaluation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery |  | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter