Streamlined Geriatric and Oncological Evaluation Based On IC Technology (NCT05720910) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
France720 participantsStarted 2024-10-15
Plain-language 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.
Who can participate
Age range
70 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. At least one moderate/severe multimorbidity inclusion criteria other than current cancer (see separate list under 5.3).
. Patients must be willing and able to comply with study procedures.
. Voluntarily signed and dated written informed consents prior to any study specific procedure.
. QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
. 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).
Exclusion criteria
. 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.