Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05720910). This is a study registration, not published results. Lead sponsor: Institut Bergonié. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 720 participants (ESTIMATED). Conditions: Breast Cancer, Comorbidities and Coexisting Conditions, Lung Cancer, Colorectal Cancer, Prostate Cancer. Interventions: OTHER: GERONTE. Primary outcome measures: Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 ) , 6 months. 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.