Streamlined Geriatric and Oncological Evaluation Based On IC Technology (NCT05720910) | Clinical Trial Compass
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 range70 Years – 130 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )