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Clinical Trials/NCT03059875
NCT03059875
Active, not recruiting
Not Applicable

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)

Poitiers University Hospital3 sites in 1 country79 target enrollmentJanuary 30, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Poitiers University Hospital
Enrollment
79
Locations
3
Primary Endpoint
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Status
Active, not recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2014
End Date
July 31, 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery

Time Frame: 5 years

Secondary Outcomes

  • Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery(5 years)
  • Patient satisfaction with their management(5 years)
  • Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard(5 years)
  • Quality of life of patients(5 years)
  • Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy(5 years)

Study Sites (3)

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