Economic Evaluation of Sarcoma Patients Management in France

NCT05272358 | Unknown

• 1 other identifier: OPTISARC
• Study Type: observational
• Target: 2,431
• Locations: 1 country
• Sites: 25

Brief Summary

The aim of this project is to (1) evaluate the efficiency of early management of sarcoma patients by the sarcoma referral network (NETSARC) vs. outside the network; (2) measure the budgetary impact of the generalization of the most cost-effective strategy across the country; (3) identify the organizational and financial constraints likely to hinder the generalization of the most cost-effective strategy and propose solutions, and finally (4) analyse the budgetary impact of a generalization of sarcoma patient care by the reference network by integrating the organizational and financial solutions proposed. The study relies on an exhaustive national cohort of all sarcoma patients who underwent primary tumor surgery for the year 2013. Patients will be allocated to four distinct strategies, each representing a different management of sarcoma patients who had a sarcoma-specialized multidisciplinary tumor board (MDTB) before the initial surgery and complete initial management in the network (strategy 1); patients who had a sarcoma-specialized MDTB before the initial surgery and initial management outside the network (strategy 2); patients who had a sarcoma-specialized MDTB after initial surgery and initial management outside the network (strategy 3); patients who had an initial management outside the network, without sarcoma-specialized MDTB neither before nor after the initial surgery (strategy 4). Matching of the National Health Data System (SNDS) and the NETSARC databases made it possible to include 2431 patients in the study. These databases will allow to obtain information on patients, estimate overall survival and identify healthcare consumption, which will be useful in achieving study's objectives.

Conditions

Sarcoma

Keywords

cost effectiveness; network; organization; payment model; sarcoma; patient' management; initial surgery; multi disciplinary tumor board

Outcome Measures

Primary Outcomes (1)

• Short-term cost-effectiveness analysis

  The main objective of this study is to evaluate the short-term effectiveness (over a 5-year period) of sarcoma patient management by the sarcoma referral network vs. outside the network. A cost-effectiveness analysis (CEA) based on the Incremental Cost-Effectiveness Ratio (ICER) will be used to compare strategies 1, 2, 3 and 4.

  5 years

Secondary Outcomes (5)

• Long-term cost-utility analysis and cost-effectiveness analysis

  15 years

• Budget Impact Analysis

  5 years

• Organizational Assessment

  5 years

• Define the incentive mechanisms most likely to neutralize the main obstacles identified in a theoretical model of cooperation

  5 years

• Pricing model

  5 years

Study Arms (4)

strategy 1: sarcoma MDTB before surgery and initial management in the NETSARC network

Patients who had a sarcoma-specialized multidisciplinary tumour board (MDTB) before the initial surgery and complete initial management (including surgery) in the network (also including patients who had a sarcoma-specialized MDTB after the initial surgery and complete initial management in the network) (strategy 1)

Other: NETSARC network

strategy 2: sarcoma MDTB before surgery and initial management outside the NETSARC network

Patients who had a sarcoma-specialized MDTB before the initial surgery and initial management (including surgery) outside the network (strategy 2)

Other: NETSARC network

strategy 3: sarcoma MDTB after surgery and initial management outside the NETSARC network

Patients who had initial management (including surgery) outside the network and a sarcoma-specialized MDTB after initial surgery (strategy 3)

Other: NETSARC network

strategy 4: No sarcoma MDTB and initial management outside the NETSARC network

Patients who had an initial management (including surgery) outside the network, without sarcoma-specialized MDTB neither before nor after the initial surgery (strategy 4).

Interventions

NETSARC network OTHER

MDTB and/or surgery in NETSARC network

strategy 1: sarcoma MDTB before surgery and initial management in the NETSARC network; strategy 2: sarcoma MDTB before surgery and initial management outside the NETSARC network; strategy 3: sarcoma MDTB after surgery and initial management outside the NETSARC network

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of sarcoma patient diagnosed in 2013 with a surgery of initial tumour.

You may qualify if:

• Sarcoma diagnosis between 01/01/2013 and 31/12/2013
• International Classification of Diseases (ICD) code 10: C49 Malignant neoplasm of other connective and soft tissue, or C48 Malignant neoplasm of retroperitoneum and peritoneum, or C40-41 Malignant neoplasm of bone and articular cartilage of limbs)
• Surgery of the primary tumour.

You may not qualify if:

• Gastro intestinal stromal tumour
• Diagnosis not confirmed by the a second histological review

Sponsors & Collaborators

• Centre Leon Berard: lead
• Saint Etienne School of Mine: collaborator
• Rennes University Hospital: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (25)

CHU Jean Minjoz

Besançon, 25000, France

RECRUITING

Institut Bergonié

Bordeaux, 33000, France

RECRUITING

Centre François Baclesse

Caen, 14000, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, 63000, France

RECRUITING

Centre Georges François Leclerc

Dijon, 21000, France

RECRUITING

CHU Saint-Pierre

La Réunion, 97000, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

CHU Dupuytren

Limoges, 87000, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

CHU Timone

Marseille, 13000, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13000, France

RECRUITING

ICM Val d'Aurelle

Montpellier, 34000, France

RECRUITING

Institut de cancérologie de Lorraine

Nancy, 54000, France

RECRUITING

Institut de Cancérologie de l'Ouest

Nantes, 44800, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06000, France

RECRUITING

CHU Cochin

Paris, 75000, France

RECRUITING

CHU Saint-Louis

Paris, 75000, France

RECRUITING

Institut Curie

Paris, 75000, France

RECRUITING

Institut jean Godinot

Reims, 51000, France

RECRUITING

CHU Pontchaillou

Rennes, 35000, France

RECRUITING

Centre Henri Becquerel

Rouen, 76000, France

RECRUITING

Institut de Cancérologie CHU Hautepierre

Strasbourg, 67000, France

RECRUITING

IUCT Institut Claudius Régaud

Toulouse, 31000, France

RECRUITING

CHU Trousseau

Tours, 37000, France

RECRUITING

Gustave Roussy

Villejuif, 94100, France

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Yves Blay, PU-PH

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionel Perrier, PhD

CONTACT

+33 478782908; lionel.perrier@lyon.unicancer.fr

Study Design

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

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: March 9, 2022
• Study Start: February 8, 2021
• Primary Completion: June 15, 2022
• Study Completion: February 8, 2024
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (25)