Trial Outcomes & Findings for A Public Health Intervention Program to Improve the Initial Management of Soft Tissue Sarcomas. (NCT NCT05007639)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

274 participants

Primary outcome timeframe

Assessed at surgery

Results posted on

2022-01-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	274
Overall Study COMPLETED	274
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program n=274 Participants 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
Age, Continuous	63.8 years n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants
Sex: Female, Male Male	158 Participants n=5 Participants
Region of Enrollment France	274 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at surgery

Population: Participants analyzed : patients with a deep tumor

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.

Outcome measures

Outcome measures
Measure	Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program n=178 Participants 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
Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Deep Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme.	145 Participants

PRIMARY outcome

Timeframe: Assessed at surgery

Population: Participants Analyzed: patients with a superficial tumor

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.

Outcome measures

Outcome measures
Measure	Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program n=89 Participants 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
Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Superficial Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme)	33 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program n=232 Participants 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
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)	120 Participants

PRIMARY outcome

Timeframe: Assessed up to 2 months prior to biopsy

Population: Participants Analyzed: patients with a 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.

Outcome measures

Outcome measures
Measure	Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program n=157 Participants 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
Adherence Rate to Discussion in Multidisciplinary Team Meeting (Before Implementation of the Public Health Intervention Programme)	10 Participants

Adverse Events

Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Simone Mathoulin-Pélissier

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 (0)5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place