Département Universitaire de Médecine Générale - Université Toulouse III Paul Sabatier, Toulouse, France
UMR 1295 INSERM - Université Toulouse III Paul Sabatier, Toulouse, France.
BMJ Open. 2023 Jan 30;13(1):e062219. doi: 10.1136/bmjopen-2022-062219.
Patients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management of these patients. To explore this hypothesis, we run a randomised clinical trial, called 'Concertation de REtour à DOmicile, CREDO'. The main objective is to explore the effectiveness of a 'return home' consultation compared with standard care. The number of unscheduled visits to care centres is used to evaluate the effectiveness of the treatment.
CREDO is a multicentre, randomised, open-label, prospective trial. It takes place in two specialised cancer care centres in southern France (Occitania region). Patient inclusion criteria are: be over 18 years old; be treated with a first cycle of metastatic chemotherapy in a specialised cancer care centre; have a metastatic solid cancer and be returning home after treatment. Patients are randomised in two arms: standard-arm (conventional management) or intervention-arm (CREDO management). In the intervention arm, a 'return home' consultation is carried out in three steps. First, the investigating GP (GP with specific skills in oncology) from the specialised care centre collects information about the patient and patient's management choices. Then, the investigating GP conducts an interview with the patient's referring GP to quickly communicate and discuss information about the patient. Finally, the investigating GP summarises these exchanges and transmits this information to the care centres chosen by the patient.All the patients are followed for 1 year.Statistical and medicoeconomic analysis are planned.
This clinical trial is registered under ClinicalTrials.gov identifier and was approved by the ethics committee of South-Western French Committee for the Protection of Persons (number: 2016-A01587-44) and from the French National Drug Safety Agency (ANSM, number: 2016111500034).An international publication of the final results and conference presentations will be planned.
NCT02857400.
癌症患者通常由多名医疗保健专业人员共同管理。具有肿瘤学专业技能的全科医生可以促进医院和全科医生之间在这些患者管理方面的护理协调。为了探索这一假设，我们开展了一项名为“Concertation de REtour à DOmicile，CREDO”的随机临床试验。主要目的是探索“回家”咨询与标准护理相比的有效性。未预约就诊次数用于评估治疗效果。
CREDO 是一项多中心、随机、开放标签、前瞻性试验。该试验在法国南部两个专门的癌症护理中心（奥克西塔尼地区）进行。患者入选标准为：年龄超过 18 岁；正在专门的癌症护理中心接受转移性化疗的首个周期治疗；患有转移性实体瘤，并在治疗后返回家中。患者被随机分为两组：标准组（常规治疗）或干预组（CREDO 治疗）。在干预组中，进行了三步“回家”咨询。首先，来自专门护理中心的调查全科医生（具有肿瘤学专业技能的全科医生）收集有关患者和患者管理选择的信息。然后，调查全科医生与患者的转诊全科医生进行访谈，以快速交流和讨论有关患者的信息。最后，调查全科医生总结这些交流并将这些信息传递给患者选择的护理中心。所有患者均随访 1 年。计划进行统计和医疗经济学分析。
该临床试验在 ClinicalTrials.gov 标识符下注册，并获得了法国西南地区保护人员伦理委员会（编号：2016-A01587-44）和法国国家药物安全局（编号：2016111500034）的批准。计划对最终结果进行国际发表和会议报告。
NCT02857400。
