SurgeryNCT03059875
Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter)
A study testing Medical consultation for a Standardized Geriatric Evaluation in people with Surgery and 75 Years Old and More, run by Poitiers University Hospital at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older, women only
- Conditions the study is for
- Surgery, 75 Years Old and More, Female Breast Cancer
- What is being tested?
- Medical consultation for a Standardized Geriatric Evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 6 sitesFrance
- Study dates
- 30 Jan 2014to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- First breast cancer localized, indication of surgery
- Onco-geriatric filter (FOG) >= 1 ou < 4
Who cannot join
- Male, less of 75 years old
- Contraindication of surgery
- Breast cancer with metastasis
- Onco-geriatric filter (FOG) = 0 or 4
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hospital Center
Angoulême, 16959
Hospital center
Bressuire, 79302
Hospital Center
La Rochelle, 17019
Hospital center
Niort, 79021
University Hospital Center
Poitiers, 86000
Hospital center
Saintes, 17108
About this study
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)
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.
- Conditions
- Surgery, 75 Years Old and More, Female Breast Cancer
- Being tested
- Medical consultation for a Standardized Geriatric Evaluation
- Keywords
- Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical consultation for a Standardized Geriatric EvaluationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Strategy A | Other | Comprehensive Geriatric Assessment before the surgery of breast Receives: Behavioral: Medical consultation for a Standardized Geriatric Evaluation |
| Strategy B | Other | Comprehensive Geriatric Assessment after the surgery of breast Receives: Behavioral: Medical consultation for a Standardized Geriatric Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Measured: 5 years
Secondary outcomes (5)
Quality of life of patients
Questionnary EORTC QLQ - BR33
Measured: 5 years
Patient satisfaction with their management
Questionnary REPERES 60 - Consumer Satisfaction Survey
Measured: 5 years
Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard
Measured: 5 years
Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Measured: 5 years
Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start30 Jan 2014
- Primary completion31 Jul 2021
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059875
- Sponsor's protocol ID
- GYNECO ONCOGER
- Status last verified
- Sep 2021
- First submitted
- 9 Feb 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03059875
- Acronym / sponsor ID
- GYNECO ONCOGER
- Conditions
- Surgery, 75 Years Old and More, Female Breast Cancer
- Keywords
- Breastcancer, Standardized Geriatric Evaluation, Onco-Geriatric Filter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2014 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy A | Other | Behavioral: Medical consultation for a Standardized Geriatric EvaluationComprehensive Geriatric Assessment before the surgery of breast |
| Strategy B | Other | Behavioral: Medical consultation for a Standardized Geriatric EvaluationComprehensive Geriatric Assessment after the surgery of breast |
Who may qualify
- Ages
- 75 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- First breast cancer localized, indication of surgery
- Onco-geriatric filter (FOG) >= 1 ou < 4
Key exclusion criteria (4 listed)
- Male, less of 75 years old
- Contraindication of surgery
- Breast cancer with metastasis
- Onco-geriatric filter (FOG) = 0 or 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical consultation for a Standardized Geriatric Evaluation | Behavioural | Strategy A, Strategy B |
Primary outcome
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Time frame: 5 years
5 secondary outcomes
Quality of life of patients
Time frame: 5 years
Patient satisfaction with their management
Time frame: 5 years
Compare proportions of patients who received adjuvant chemotherapy and / or radiation standard
Time frame: 5 years
Compare time to take care of Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery
Time frame: 5 years
Compare the proportions of patients receiving adjuvant therapy, including complete hormone therapy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical consultation for a Standardized Geriatric Evaluation in people with Surgery and 75 Years Old and More, run by Poitiers University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Comprehensive Geriatric Assessment before the surgery and Comprehensive Geriatric Assessment after the surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.