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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Cancer; Clinical Research

Treatments: Behavioral: interventions of the Cancéropôle Nord-Ouest

Study type: Interventional

Funder types: Other

Identifiers

NCT02765451

RNI 2015-05-DR-BARBARE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

A : 1 year of intervention

Active Comparator group

Description:

interventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years.

Treatment:

Behavioral: interventions of the Cancéropôle Nord-Ouest

B : 2 years of intervention

Active Comparator group

Description:

interventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year.

Treatment:

Behavioral: interventions of the Cancéropôle Nord-Ouest