Streamlined Geriatric and Oncological Evaluation Based On IC Technology
FRONE
1 other identifier
interventional
720
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Oct 2024
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedStudy Start
First participant enrolled
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
January 15, 2026
January 1, 2026
2.5 years
January 20, 2023
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
Quality of life assessed by the quality of life questionnaire (EORTC QLQ-C30) questionnaire at 6 months after inclusion: * Normalised global health status score * Normalised score of the physical functioning scale * Normalised score of the emotional functioning scale the minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
6 months
Secondary Outcomes (14)
Quality of life of elders cancer patients
baseline 3, 9 and 12 months
Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
baseline 3, 9 and 12 months
Survival
at 12 months
Patient frailty
baseline, 3, 6, 9 and 12 months
Patient autonomy,
baseline, 3, 6, 9 and 12 months
- +9 more secondary outcomes
Study Arms (2)
GERONTE
EXPERIMENTALThe clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway;
CONTROL ARM
NO INTERVENTIONPatients included in the control arm will be managed according to the standard of care.
Interventions
The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway
Eligibility Criteria
You may qualify if:
- Age ≥ 70 years old.
- New or progressive cancer (breast, lung, colorectal, prostate), histologically proven or strong clinical suspicion, fulfilling the tumor specific criteria.
- Estimated life expectancy greater than 6 months.
- Patients must be willing and able to comply with study procedures.
- Voluntarily signed and dated written informed consents prior to any study specific procedure.
- Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public health).
- Non-metastatic breast cancer (M0):
- \- No prior treatment for the current breast cancer.
- \- All 3 criteria required:
- o Clinical staging: cT2-3-4 Nany, or cTany N1-2-3;
- The cancer specialist considers\* surgery;
- The cancer specialist considers\* radiotherapy and/or chemotherapy. 9.2. Metastatic breast cancer (M1): Both criteria required:
- The cancer specialist considers\* chemotherapy or PARP-inhibitors or mTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6 inhibitors is allowed;
- The patient received maximum 1 prior line of chemotherapy for metastatic disease.
- 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
- +26 more criteria
You may not qualify if:
- Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures.
- Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial.
- Patients and caregivers are unable or unwilling to use ICT-devices (tablet,computer, smartphone) or the Internet according to protocol.
- Patient already included in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Bergoniélead
- EUCLID Clinical Trial Platformcollaborator
- University of Bordeauxcollaborator
Study Sites (10)
Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
Institut Bergonié
Bordeaux, 33076, France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000, France
Centre Léon Bérard
Lyon, 69373, France
Centre Azuréen de Cancérologie
Mougins, 06250, France
Centre Hospitalier Universitaire de Nice
Nice, 06000, France
Centre Antoine Lacassagne
Nice, 06189, France
Hôpital Tenon AP-HP
Paris, 75020, France
Centre Eugène Marquis
Rennes, 35042, France
Groupe Hospitalier Rance Emeraude
St-Malo, 35400, France
Related Publications (1)
Hamaker ME, Wildiers H, Ardito V, Arsandaux J, Barthod-Malat A, Davies P, Degol L, Ferrara L, Fourrier C, Kenis C, Kret M, Lalet C, Pelissier SM, O'Hanlon S, Rostoft S, Seghers N, Saillour-Glenisson F, Staines A, Schwimmer C, Thevenet V, Wallet C, Soubeyran P. Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials. J Geriatr Oncol. 2024 May;15(4):101761. doi: 10.1016/j.jgo.2024.101761. Epub 2024 Apr 5.
PMID: 38581958DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2023
First Posted
February 9, 2023
Study Start
October 15, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
January 15, 2026
Record last verified: 2026-01