Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)

Study Overview
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Brief Summary
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This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of clinical research in non-academic health institution. The randomization, in open label,determines the duration of the interventions. Half of participants will receive the interventions during 2 years, while the other half during 1 year.

Detailed Description
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French National recommendations ask to increase the accessibility of patients to clinical trials. But this accessibility is far from the optimal care in non-university healthcare institutions (public and private hospital). These non-academic healthcare facilities support at national level about 60% of chemotherapy and 70% of radiotherapy, but only 17% of the inclusions in trials. A dissociation exist between a care package guaranteed on quality criteria (criteria to obtain the capacity to treat the cancers in healthcare institution) distributed all over the country, and the research, mainly concentrated in few referral centers (University hospital and French Comprehensive Cancer Centers). Clinical trials allow patients to have early access to new treatments, optimal and formalized information, and supported by physicians in connection with a strict protocol for patients included. Several studies have shown the existence of geographical and socio-economic determinants for access to reference centers and for the duration of survival of cancer patients. In France, it was found that for patients with gastrointestinal cancer, the remoteness of the place of residence compared to the nearest referral center and a higher level of deprivation decreased the probability of being supported in a reference center. The hypothesis of the ERNU study is that aid from the Cancéropole Nord-Ouest facilitates clinical research activity resulting in a significant development of inclusions in non-university centers of the french north-west inter-region with an influence on the social and geographical inequalities recruitment.

Official Title
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Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)

Conditions
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Clinical Research, Cancer

Intervention / Treatment
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* Behavioral: interventions of the Cancéropôle Nord-Ouest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: French Health institutions of the Basse-Normandie, Haute-Normandie, Nord-Pas-de-Calais and Picardie. Health institutions non-academic public and private. Health institutions authorized to treat cancer. Exclusion Criteria: N/A
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A : 1 year of intervention<br>interventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years. | Behavioral: interventions of the Cancéropôle Nord-Ouest<br>* During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of straightforward studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....<br>|
| Active Comparator: B : 2 years of intervention<br>interventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year. | Behavioral: interventions of the Cancéropôle Nord-Ouest<br>* During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of straightforward studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of inclusions in clinical trials of patients | Measure the increase in inclusions in clinical trials of patients attending a Hospital or a private clinic authorized to treat cancer associated with a support provided by the Cancéropôle Nord-Ouest | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of social inequalities recruitment in clinical trials associated with the intervention of the Cancéropôle Nord-Ouest | assessment of the average of the reduction of social inequalities recruitment in clinical trial before and after the intervention of the Cancéropöle Nord-Ouest in each centers and in global. the social inequalities are calculated with the social and demographic tool developped by the french national institute of statistic and economic studies | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-academic, health institution, development, clinical research, cancer, private hospital, public hospital, northwestern france, france, hospitals