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

Surgery Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03059875
• Other study ID #: GYNECO ONCOGER
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 30, 2014
• Est. completion date: July 31, 2025

Study information

• Verified date: September 2021
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 79
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 75 Years Old and More
• Breast Neoplasms
• Female Breast Cancer
• Surgery

Intervention

Behavioral:
• Medical consultation for a Standardized Geriatric Evaluation

Locations

Country	Name	City	State
France	Hospital Center	Angouleme
France	Hospital center	Bressuire
France	Hospital Center	La Rochelle
France	Hospital center	Niort
France	University Hospital Center	Poitiers
France	Hospital center	Saintes

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

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