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临床试验/NCT02765451
NCT02765451已完成不适用

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

Centre Hospitalier Universitaire, Amiens80 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
80
主要终点
Number of inclusions in clinical trials of patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

A : 1 year of intervention

Active Comparator

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

干预措施: interventions of the Cancéropôle Nord-Ouest (Behavioral)

B : 2 years of intervention

Active Comparator

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

干预措施: interventions of the Cancéropôle Nord-Ouest (Behavioral)

结局指标

主要结局

Number of inclusions in clinical trials of patients

时间窗: up to 2 years

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

次要结局

  • Reduction of social inequalities recruitment in clinical trials associated with the intervention of the Cancéropôle Nord-Ouest(up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (80)

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