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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05007639
Acronym
IPSSAR
Enrollment
274
Registered
2021-08-16
Start date
2006-11-02
Completion date
2017-12-31
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

publich health intervention programme

Brief 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).

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).

Interventions

OTHERPublic 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).

OTHERNo public Health intervention programme

Sponsors

Institut Bergonié
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Deep Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme.Assessed at surgeryImaging 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.
Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Superficial Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme)Assessed at surgeryImaging 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.
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)Assessed up to 2 months following diagnosisDiagnosis 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.
Adherence Rate to Discussion in Multidisciplinary Team Meeting (Before Implementation of the Public Health Intervention Programme)Assessed up to 2 months prior to biopsyDiscussion 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.

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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, 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). No public Health intervention programme
274
Total274

Baseline characteristics

CharacteristicPatients Diagnosed BEFORE Implementation of the Public Health Intervention Program
Age, Continuous63.8 years
Region of Enrollment
France
274 Participants
Sex: Female, Male
Female
116 Participants
Sex: Female, Male
Male
158 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Deep Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme.

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.

Time frame: Assessed at surgery

Population: Participants analyzed : patients with a deep tumor

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients Diagnosed BEFORE Implementation of the Public Health Intervention ProgramAdherence Rate to Diagnosis Imaging Guidelines for Patients With a Deep Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme.145 Participants
Primary

Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Superficial Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme)

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.

Time frame: Assessed at surgery

Population: Participants Analyzed: patients with a superficial tumor

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients Diagnosed BEFORE Implementation of the Public Health Intervention ProgramAdherence Rate to Diagnosis Imaging Guidelines for Patients With a Superficial Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme)33 Participants
Primary

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)

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.

Time frame: Assessed up to 2 months following diagnosis

Population: Participants Analyzed: patients with a deep tumor over 5 cm in size or tumors \<5 cm increasing in size

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients Diagnosed BEFORE Implementation of the Public Health Intervention ProgramAdherence 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)120 Participants
Primary

Adherence Rate to Discussion in Multidisciplinary Team Meeting (Before Implementation of the Public Health Intervention Programme)

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.

Time frame: Assessed up to 2 months prior to biopsy

Population: Participants Analyzed: patients with a biopsy

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients Diagnosed BEFORE Implementation of the Public Health Intervention ProgramAdherence Rate to Discussion in Multidisciplinary Team Meeting (Before Implementation of the Public Health Intervention Programme)10 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026