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No phaseActive, not recruiting

Streamlined Geriatric and Oncological Evaluation Based On IC Technology (FRONE)

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

Sponsor
Institut Bergonié (Academic or other)
Enrolment
720 planned
Conditions
Breast Cancer; Comorbidities and Coexisting Conditions; Lung Cancer; Colorectal Cancer; Prostate Cancer
Interventions
GERONTE
Ages
older adults
Registry
NCT05720910

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )

History

  1. Study completion expected

  2. Primary completion

  3. Last registry update

  4. Started

  5. Registered