A Public Health Intervention Program to Improve the Initial Management of Soft Tissue Sarcomas. — IPSSAR  

Sarcoma Clinical Trial

Official title: A Public Health Intervention Program to Improve the Initial Management of Soft Tissue Sarcomas.

Status Completed

Clinical Trial Summary

Sarcomas are rare tumours that represent less than 1% of cancers. Their actual incidence in France, however, is not known. The chances of survival at 5 years, without signs of the disease, are currently estimated at about 60%. The possibility of soft tissue sarcoma (STS) is frequently unrecognised, leading to an inappropriate initial diagnostic process and often to inadequate surgery. Compliance with good practice guides, which we can recall were targeted at oncologists, is good when the patient's record is discussed within the framework of a multidisciplinary consultation. The consequences of inadequate initial management, however, can be critical: unplanned surgery results in the need for systematic repeat procedure, with residual tumour found in more than half of cases, and the absence of multidisciplinary care has a deleterious impact on local disease control and specific survival.

The objective of the study is to measure the impact of a public health intervention programme focused on the initial management of STS among all professionals who may come to suspect or diagnose soft tissue sarcoma. For this project, the 4 regions involved in the Cancéropôle du Grand Sud-Ouest, France (Aquitaine, Languedoc-Roussillon, Limousin and Midi-Pyrénées) propose to implement actions targeted at general practitioners, treating physicians and non-specialist surgeons in the field of STS, aimed at improving initial care.

An improvement in initial management (diagnosis and assessment) which should allow an improvement in the loco-regional control of these diseases and in the specific survival of the patients. The actions recognised as effective in this study could then be adapted and extended to the rest of France via the French sarcomas group and the bone tumours study group (GSF-GETO).

Clinical Trial Description

Background: Sarcomas are rare tumours that represent less than 1% of cancers. Their actual incidence in France, however, is not known. The chances of survival at 5 years, without signs of the disease, are currently estimated at about 60%. The possibility of soft tissue sarcoma (STS) is frequently unrecognised, leading to an inappropriate initial diagnostic process and often to inadequate surgery. Compliance with good practice guides, which we can recall were targeted at oncologists, is good when the patient's record is discussed within the framework of a multidisciplinary consultation. The consequences of inadequate initial management, however, can be critical: unplanned surgery results in the need for systematic repeat procedure, with residual tumour found in more than half of cases, and the absence of multidisciplinary care has a deleterious impact on local disease control and specific survival.

Objectives: The objective of the study is to measure the impact of a public health intervention programme focused on the initial management of STS among all professionals who may come to suspect or diagnose soft tissue sarcoma. For this project, the 4 regions involved in the Cancéropôle du Grand Sud-Ouest, France (Aquitaine, Languedoc-Roussillon, Limousin and Midi-Pyrénées) propose to implement actions targeted at general practitioners, treating physicians and non-specialist surgeons in the field of STS, aimed at improving initial care.

Outline: This is a "before and after (the intervention programme)" study with a "control" group (Nantes region with multidisciplinary "sarcoma" consultation meetings organised, but where no specific intervention shall be made).

Course the intervention: The programme shall combine 3 actions: a simple dissemination of information via the regional Unions of private practice physicians and the local correspondents of the regional networks (action 1), an action in the form of oral communication during regional meetings of professionals (action 2) and an action focused on each surgeon for whom the pathologist has diagnosed soft tissue sarcoma (action 3).

Study size: It is assumed that the proposed programme shall serve to measure a 35% improvement in the proportion of adequate care (70% with intervention versus 35%). To take into account in the analysis of potential clusters of practices (professionals with similar medical practices), the number of subjects was increased to 60 observations per study phase (before/after). The results of the "Before the intervention" study should enable us to adjust the number of subjects to take into account any cluster effects, which cannot be estimated as it is, while taking into account the feasibility since these are rare tumours.

Endpoints: For each patient, the main analyses shall focus on different care quality endpoints, in particular those relating to the initial diagnosis and initial surgery stages. The elements of these endpoints shall be collected in health establishments and pathology laboratories in the regions involved.

Impacts and perspectives: An improvement in initial management (diagnosis and assessment) which should allow an improvement in the loco-regional control of these diseases and in the specific survival of the patients. The actions recognised as effective in this study could then be adapted and extended to the rest of France via the French sarcomas group and the bone tumours study group (GSF-GETO). ;

Related Conditions & MeSH terms

• Sarcoma

• NCT number: NCT05007639
• Study type: Observational
• Source: Institut Bergonié
• Status: Completed
• Start date: November 2, 2006
• Completion date: December 31, 2017