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

November 8, 2021 updated by: Institut Bergonié

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients (≥18 years old) diagnosed between 1 November 2006 and 31 December 2009 in the Aquitaine and Midi-Pyrénées administrative districts in South-West France (6 million inhabitants, 10% of the French population) with primary STS of any stage were included.

Description

Inclusion Criteria:

  • Primary soft-tissue sarcoma (STS)
  • any stage

Exclusion Criteria:

  • Patients with visceral, bone, uterus or Kaposi's sarcoma, gastrointestinal stromal tumors, or mesotheliomas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed BEFORE implementation of the public health intervention program
All adult patients (≥18 years old) diagnosed between 1 November 2006 and 31 December 2007 in the Aquitaine and Midi-Pyrénées administrative districts in South-West France (6 million inhabitants, 10% of the French population) with primary STS of any stage were included. Patients with visceral, bone, uterus or Kaposi's sarcoma, gastrointestinal stromal tumors, or mesotheliomas were not included. Patients being treated for recurrence, and patients diagnosed outside of the administrative districts were not eligible. STS diagnoses were made in public or private pathology laboratories. Data were collected from all relevant sources: pathology reports, medical records from private and public centers,
Other: No public Health intervention programme
Patients diagnosed DURING implementation of the public health intervention program
Same eligibility criteria as for the group "before implementation of the public health intervention program", except that patients were diagnosed between 1 january 2008 and 31 october 2008.
Patients diagnosed AFTER implementation of the public health intervention program
Same eligibility criteria as for the group "before implementation of the public health intervention program", except that patients were diagnosed between 1 November 2008 and 31 December 2009.
Other: Public Health intervention programme
The public health intervention programme combined 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Deep Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme.
Time Frame: Assessed at surgery

Imaging criterion for patients with a deep tumor was considered "compliant" if patients received magnetic resonance imaging (MRI) or scan of the tumor zone before surgery.

Adherence rate was calculated as the number of patients with "compliant imaging criterion" among patients with a deep tumor.
Assessed at surgery
Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Superficial Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme)
Time Frame: Assessed at surgery

Imaging criterion for patients with a superficial tumor was considered "compliant" if patients received an MRI, scan, or ultrasound before surgery.

Adherence rate was calculated as the number of patients with "compliant imaging criterion" among patients with a superficial tumor.
Assessed at surgery
Adherence Rate to Diagnosis Technique (Biopsy) Guidelines for Patients With Deep Tumors Over 5 cm in Size or Tumors <5 cm Increasing in Size (Before Implementation of the Public Health Intervention Programme)
Time Frame: Assessed up to 2 months following diagnosis

Diagnosis technique (biopsy) was considered "compliant" for deep tumors over 5 cm in size or tumors <5 cm increasing in size if the diagnosis was made from a percutaneous or surgical biopsy.

Adherence rate was calculated as the number of patients with "compliant diagnosis technique" among patients with deep tumors over 5 cm in size or tumors <5 cm increasing in size.
Assessed up to 2 months following diagnosis
Adherence Rate to Discussion in Multidisciplinary Team Meeting (Before Implementation of the Public Health Intervention Programme)
Time Frame: Assessed up to 2 months prior to biopsy

Discussion in multidisciplinary team (MDT) meeting was considered "compliant" if the patient record was discussed in MTD meeting before biopsy.

Adherence rate was calculated as the number of patients with "compliant MDT meeting" among sarcoma patients with a biopsy.
Assessed up to 2 months prior to biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Principal Investigator: Simone MATHOULIN-PELISSIER, MD, PhD, Institut Bergonié, COmprehensive Cancer Center, Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2006

Primary Completion (Actual)

December 31, 2011

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2008-IPSSAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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