RecruitingNot ApplicableNCT05720910

Streamlined Geriatric and Oncological Evaluation Based On IC Technology

Streamlined Geriatric and Oncological Evaluation Based on ic Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients


Sponsor

Institut Bergonié

Enrollment

720 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 70 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a comprehensive geriatric assessment conducted via digital technology (tablet-based questionnaires and assessments) can help tailor cancer treatment plans for older adults (70+) with breast, lung, colorectal, or prostate cancer who also have other health conditions. The goal is to improve outcomes by catching hidden frailty or problems that standard oncology assessments might miss. **You may be eligible if...** - You are 70 years or older - You have a new or progressing cancer (breast, lung, colorectal, or prostate) with histological confirmation or strong clinical suspicion - You have at least one significant additional health condition beyond your cancer - You are a patient in the French healthcare system (this study is conducted in France) - You have completed a quality of life questionnaire at study entry **You may NOT be eligible if...** - Your life expectancy is less than 6 months - You have already received treatment for your current cancer at the recruiting hospital (for non-metastatic disease) - You are not willing or able to follow study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERGERONTE

The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway


Locations(10)

Centre Hospitalier de la Côte Basque

Bayonne, France

Institut Bergonié

Bordeaux, France

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Centre Léon Bérard

Lyon, France

Centre Azuréen de Cancérologie

Mougins, France

Centre Hospitalier Universitaire de Nice

Nice, France

Centre Antoine Lacassagne

Nice, France

Hôpital Tenon AP-HP

Paris, France

Centre Eugène Marquis

Rennes, France

Groupe Hospitalier Rance Emeraude

St-Malo, France

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NCT05720910


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