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

P

Poitiers University Hospital

Status

Active, not recruiting

Conditions

Surgery
75 Years Old and More
Female Breast Cancer

Treatments

Behavioral: Medical consultation for a Standardized Geriatric Evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT03059875
GYNECO ONCOGER

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

Female

Ages

75+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

79 participants in 2 patient groups

Strategy A
Other group
Description:
Comprehensive Geriatric Assessment before the surgery of breast
Treatment:
Behavioral: Medical consultation for a Standardized Geriatric Evaluation
Strategy B
Other group
Description:
Comprehensive Geriatric Assessment after the surgery of breast
Treatment:
Behavioral: Medical consultation for a Standardized Geriatric Evaluation

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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