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

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03059875
Enrollment
79
Registered
2017-02-23
Start date
2014-01-30
Completion date
2025-07-31
Last updated
2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

75 Years Old and More, Female Breast Cancer, Surgery

Keywords

Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter

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.

Interventions

BEHAVIORALMedical consultation for a Standardized Geriatric Evaluation

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery5 years

Secondary

MeasureTime frameDescription
Quality of life of patients5 yearsQuestionnary EORTC QLQ - BR33
Patient satisfaction with their management5 yearsQuestionnary REPERES 60 - Consumer Satisfaction Survey
Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard5 years
Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery5 years
Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy5 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026