Back to resultsPlace of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)
Primary Purpose
Surgery, 75 Years Old and More, Female Breast Cancer
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Medical consultation for a Standardized Geriatric Evaluation
Sponsored by
About this trial
This is an interventional prevention trial for Surgery focused on measuring Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter
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
Sites / Locations
- Hospital Center
- Hospital center
- Hospital Center
- Hospital center
- University Hospital Center
- Hospital center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Strategy A
Strategy B
Arm Description
Comprehensive Geriatric Assessment before the surgery of breast
Comprehensive Geriatric Assessment after the surgery of breast
Outcomes
Primary Outcome Measures
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Secondary Outcome Measures
Quality of life of patients
Questionnary EORTC QLQ - BR33
Patient satisfaction with their management
Questionnary REPERES 60 - Consumer Satisfaction Survey
Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard
Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy
Full Information
NCT ID
NCT03059875
First Posted
February 9, 2017
Last Updated
September 28, 2021
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03059875
Brief Title
Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 30, 2014 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, 75 Years Old and More, Female Breast Cancer
Keywords
Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strategy A
Arm Type
Other
Arm Description
Comprehensive Geriatric Assessment before the surgery of breast
Arm Title
Strategy B
Arm Type
Other
Arm Description
Comprehensive Geriatric Assessment after the surgery of breast
Intervention Type
Behavioral
Intervention Name(s)
Medical consultation for a Standardized Geriatric Evaluation
Primary Outcome Measure Information:
Title
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Quality of life of patients
Description
Questionnary EORTC QLQ - BR33
Time Frame
5 years
Title
Patient satisfaction with their management
Description
Questionnary REPERES 60 - Consumer Satisfaction Survey
Time Frame
5 years
Title
Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard
Time Frame
5 years
Title
Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Time Frame
5 years
Title
Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Center
City
Angouleme
ZIP/Postal Code
16959
Country
France
Facility Name
Hospital center
City
Bressuire
ZIP/Postal Code
79302
Country
France
Facility Name
Hospital Center
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
Hospital center
City
Niort
ZIP/Postal Code
79021
Country
France
Facility Name
University Hospital Center
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hospital center
City
Saintes
ZIP/Postal Code
17108
Country
France
12. IPD Sharing Statement
Learn more about this trial
Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)
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