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

NCT05007639 | Completed Results

• 1 other identifier: IB2008-IPSSAR
• Study Type: observational
• Target: 274
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Sarcoma

Keywords

publich health intervention programme

Outcome Measures

Primary Outcomes (4)

• 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.

  Assessed at surgery

• 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.

  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)

  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)

  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

Study Arms (3)

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

Interventions

Public Health intervention programme OTHER

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).

Patients diagnosed AFTER implementation of the public health intervention program

No public Health intervention programme OTHER

Patients diagnosed BEFORE implementation of the public health intervention program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead

Related Publications (1)

• Mathoulin-Pelissier S, Chevreau C, Bellera C, Bauvin E, Saves M, Grosclaude P, Albert S, Goddard J, Le Guellec S, Delannes M, Bui BN, Mendiboure J, Stoeckle E, Coindre JM, Kantor G, Kind M, Cowppli-Bony A, Hoppe S, Italiano A. Adherence to consensus-based diagnosis and treatment guidelines in adult soft-tissue sarcoma patients: a French prospective population-based study. Ann Oncol. 2014 Jan;25(1):225-31. doi: 10.1093/annonc/mdt407. Epub 2013 Nov 26.

  PMID: 24285018 RESULT

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Pr Simone Mathoulin-Pélissier
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 (0)5 56 33 33 33

Study Officials

• Simone MATHOULIN-PELISSIER, MD, PhD

  Institut Bergonié, COmprehensive Cancer Center, Bordeaux, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 16, 2021
• Study Start: November 2, 2006
• Primary Completion: December 31, 2011
• Study Completion: December 31, 2017
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share