Actively Recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Led by Institut Bergonié · Updated on 2026-01-15
720
Participants Needed
10
Research Sites
128 weeks
Total Duration
On this page
Sponsors
I
Institut Bergonié
Lead Sponsor
E
EUCLID Clinical Trial Platform
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France. Study design is a stepped wedge randomised controlled trial. Clusters will be participating hospitals, comprising eight investigating sites in total (Figure 2). This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. The primary endpoint is the Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire at 6 months after GERONTE implementation. It has 3 sub-scores that will be analysed independently, with alpha risk adjustment.
CONDITIONS
Official Title
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- New or progressive breast, lung, colorectal, or prostate cancer confirmed by histology or strong clinical suspicion
- Estimated life expectancy greater than 6 months
- At least one moderate or severe additional health condition besides the current cancer
- Willing and able to comply with study procedures
- Signed informed consent before any study procedure
- Completed baseline Quality of Life questionnaire (EORTC QLQ-C30)
- Affiliated with French social security according to French biomedical research law
- Specific tumor criteria depending on cancer type and stage, including treatment considerations by cancer specialists
- For breast cancer: non-metastatic with planned surgery/radiotherapy/chemotherapy, or metastatic with limited prior chemotherapy
- For colorectal cancer: non-metastatic with no prior therapy at recruiting hospital and planned surgery/radiotherapy/chemotherapy/immunotherapy, or metastatic with first or second line systemic therapy planned
- For lung cancer: non-metastatic or metastatic with planned surgery (excluding thermoablation alone), radiotherapy (excluding SBRT), or systemic therapy excluding certain monotherapies
- For prostate cancer: non-metastatic or metastatic with planned radiotherapy, hormone therapy, or specified systemic treatments
You will not qualify if you...
- Mental illness or cognitive impairment limiting consent or trial participation
- Participation in another interventional trial with non-registered anticancer drugs or geriatric intervention trial
- Patient or caregiver unable or unwilling to use internet devices (tablet, computer, smartphone) as required
- Prior inclusion in this study
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
Actively Recruiting
2
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
3
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France, 85000
Actively Recruiting
4
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
5
Centre Azuréen de Cancérologie
Mougins, France, 06250
Actively Recruiting
6
Centre Hospitalier Universitaire de Nice
Nice, France, 06000
Actively Recruiting
7
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
8
Hôpital Tenon AP-HP
Paris, France, 75020
Actively Recruiting
9
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
10
Groupe Hospitalier Rance Emeraude
St-Malo, France, 35400
Actively Recruiting
Research Team
P
Pierre-Louis SOUBEYRAN, MD, PhD
CONTACT
S
Simone MATHOULIN-PELISSIER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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