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

NCT ID: NCT03059875

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-30

Study Completion Date

2025-07-31

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.

Detailed Description

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Conditions

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Surgery 75 Years Old and More Female Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Strategy A

Comprehensive Geriatric Assessment before the surgery of breast

Group Type OTHER

Medical consultation for a Standardized Geriatric Evaluation

Intervention Type BEHAVIORAL

Strategy B

Comprehensive Geriatric Assessment after the surgery of breast

Group Type OTHER

Medical consultation for a Standardized Geriatric Evaluation

Intervention Type BEHAVIORAL

Interventions

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Medical consultation for a Standardized Geriatric Evaluation

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Center

Angoulême, , France

Site Status

Hospital center

Bressuire, , France

Site Status

Hospital Center

La Rochelle, , France

Site Status

Hospital center

Niort, , France

Site Status

University Hospital Center

Poitiers, , France

Site Status

Hospital center

Saintes, , France

Site Status

Countries

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France

Other Identifiers

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GYNECO ONCOGER

Identifier Type: -

Identifier Source: org_study_id

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