IPSSAR: A Public Health Intervention Program to Improve the Initial Management of Soft Tissue Sarcomas.
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Deep Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme. [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.
- Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Superficial Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme) [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.
- 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 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.
- Adherence Rate to Discussion in Multidisciplinary Team Meeting (Before Implementation of the Public Health Intervention Programme) [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut Bergonié
Investigators
- Principal Investigator: Simone MATHOULIN-PELISSIER, MD, PhD, Institut Bergonié, COmprehensive Cancer Center, Bordeaux, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IB2008-IPSSAR
Study Results
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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 274 |
| COMPLETED | 274 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program |
|---|---|
| Arm/Group Description | 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 Participants | 274 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
63.8
|
| Sex: Female, Male (Count of Participants) | |
| Female |
116
42.3%
|
| Male |
158
57.7%
|
| Region of Enrollment (Count of Participants) | |
| France |
274
100%
|
Outcome Measures
| Title | Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Deep Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants analyzed : patients with a deep tumor |
| Arm/Group Title | Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 178 |
| Count of Participants [Participants] |
145
52.9%
|
| Title | Adherence Rate to Diagnosis Imaging Guidelines for Patients With a Superficial Sarcoma Tumor (Before Implementation of the Public Health Intervention Programme) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants Analyzed: patients with a superficial tumor |
| Arm/Group Title | Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 89 |
| Count of Participants [Participants] |
33
12%
|
| Title | 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) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants Analyzed: patients with a deep tumor over 5 cm in size or tumors <5 cm increasing in size |
| Arm/Group Title | Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 232 |
| Count of Participants [Participants] |
120
43.8%
|
| Title | Adherence Rate to Discussion in Multidisciplinary Team Meeting (Before Implementation of the Public Health Intervention Programme) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants Analyzed: patients with a biopsy |
| Arm/Group Title | Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 157 |
| Count of Participants [Participants] |
10
3.6%
|
Adverse Events
| Time Frame | All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. | |
|---|---|---|
| Adverse Event Reporting Description | All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. | |
| Arm/Group Title | Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Serious Adverse Events |
||
| Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Patients Diagnosed BEFORE Implementation of the Public Health Intervention Program | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Pr Simone Mathoulin-Pélissier |
|---|---|
| Organization | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR |
| Phone | +33 (0)5 56 33 33 33 |
| s.mathoulin@bordeaux.unicancer.fr |
- IB2008-IPSSAR