Clinical trial NCT03059875: Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgery
75 Years Old and More
Female Breast Cancer
Keywords: Breastcancer
Standardized Geriatric Evaluation
Onco-Geriatric Filter
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 79
Sex: FEMALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life of patients
timeFrame: 5 years
measure: Patient satisfaction with their management
timeFrame: 5 years
measure: Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard
timeFrame: 5 years
measure: Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
timeFrame: 5 years
measure: Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy
timeFrame: 5 years
Other outcomes:
Locations:
city: Angouleme
country: France
facility: Hospital Center
city: Bressuire
country: France
facility: Hospital center
city: La Rochelle
country: France
facility: Hospital Center
city: Niort
country: France
facility: Hospital center
city: Poitiers
country: France
facility: University Hospital Center
city: Saintes
country: France
facility: Hospital center
Study officials:
References: