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.
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. A total of 10 patients by step are to be included in each center; these 10 patients must be regularly included along the 2-month period of each step. If 10 patients are already included before the end of the 2 months' step period, the center has to stop the inclusions till the beginning of the subsequent step. If a center, near to the end of a step, is far from reaching of the 10 patients' inclusion, it must increase the speed of its inclusions to be as close as possible of 10 patients included at the end of the step. In each center, patient sample has to be representative of type of cancer managed in the center, along the trial duration. The repartition of cancer types must be homogeneous along the steps and during the trial duration. All participating investigating sites will have study collaborators in charge of organizing intervention implementation and data collection. The intervention will be prepared prior to the start of the trial, so that each investigating site can implement it as defined by the randomisation. Each center engaged to participate needs to participate till the end of the trial. A center commitment to participate will be requested before each center involvement to avoid center withdrawal after the start of the trial. Quantitative data regarding the myPatientSpace adapted for GERONTE app usage will be collected at each step and in each cluster by study collaborators, from the beginning of GERONTE system implementation. Care outcome data (Quality of life, anxiety, autonomy, additional hospitalisation, mortality...) will be collected by local referents at 3, 6, 9 and 12 months after inclusion in GERONTE. The data necessary to calculate the real cost of the intervention, of its implementation and of resource use data of patient management will be continuously collected during follow-up. GERONTE patient-centered system implementation and usage will be collected by the local referents in each center. Qualitative analysis will be performed in each center at GERONTE system implementation and during follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
720
The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway
Centre Hospitalier de la Côte Basque
Bayonne, France
RECRUITINGInstitut Bergonié
Bordeaux, France
RECRUITINGCentre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGCentre Azuréen de Cancérologie
Mougins, France
RECRUITINGCentre Hospitalier Universitaire de Nice
Nice, France
RECRUITINGCentre Antoine Lacassagne
Nice, France
RECRUITINGHôpital Tenon AP-HP
Paris, France
RECRUITINGCentre Eugène Marquis
Rennes, France
RECRUITINGGroupe Hospitalier Rance Emeraude
St-Malo, France
RECRUITINGQuality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
Quality of life assessed by the quality of life questionnaire (EORTC QLQ-C30) questionnaire at 6 months after inclusion: * Normalised global health status score * Normalised score of the physical functioning scale * Normalised score of the emotional functioning scale the minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
Time frame: 6 months
Quality of life of elders cancer patients
Scores of the quality of life questionnaire for elderly cancer patients.(QLQ-ELD14). The minimum value is 14 and the maximum value is 40, and higher scores mean a worse result.
Time frame: baseline 3, 9 and 12 months
Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 )
The quality of life questionnaire (QLQ-C30) scores. The minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
Time frame: baseline 3, 9 and 12 months
Survival
Overall survival and progression-free survival
Time frame: at 12 months
Patient frailty
Score of the Clinical frailty scale
Time frame: baseline, 3, 6, 9 and 12 months
Patient autonomy,
Dependence score of the Activities of Daily Living scale (ADL); Proportion of patients living at home; Number of completed chair stands in 30 seconds
Time frame: baseline, 3, 6, 9 and 12 months
Patient weight evolution
Weight in Kilograms
Time frame: baseline, 3, 6, 9 and 12 months
Patient anxiety
Score of Hospital Anxiety and Depression (HAD) scale. The minimum value is 0 and the maximum value is 21, and higher scores mean a worse result.
Time frame: baseline, 3, 6, 9 and 12 months
institutionalisation
Proportion of patient institutionalised per participants
Time frame: 6 and 12 months
unscheduled hospitalisations
Proportion of unscheduled hospitalisations per participants
Time frame: 6 and 12 months
Cost per life years gained
using utility assessed through normalised scores of EQ-5D-5L questionnaire
Time frame: baseline, 3, 6, 9 and 12 months
Caregiver burden in health, psychological well-being, finances, social life and relationship with patient
Zarit Burden Interview
Time frame: baseline, 3, 6, 9 and 12 months
Patient experience of person-centered coordinated care
Person-Centered Coordinated Care Experience Questionnaire (P3CEQ)The minimum value is 0 and the maximum value is 45, and higher scores mean a better result.
Time frame: 6 and 12 months
Patient, physician and health-professionals-reported overall satisfaction with the IC technology of the GERONTE system
Score derived from the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps using the Patient version for patient satisfaction and the provider version for physician and health-professional.The minimum value is 0 and the maximum value is 126, and higher scores mean a better result.
Time frame: 6 and 12 months
GERONTE patient-centered system implementation and usage
use of the myPatientSpace adapted for GERONTE app measures, for instance: number and frequency of connections.
Time frame: 6 months
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