Anthropological, Socio-cultural and Psychological Surgeons' Factors in Oncology and Brakes for Evaluation of Innovations (SURGprofil)

May 25, 2023 updated by: Institut Claudius Regaud

Evaluation of Anthropological, Socio-cultural and Psychological Factors of Surgeons Practising in Oncology Which Condition Brakes in the Evaluation of Surgical Innovations

The field of surgery continues to benefit from innovative solutions, changing surgical methods and techniques. Evaluation in terms of efficacy and Quality-Safety is an essential topic that directly affects the introduction of innovations. It is essential to carry out a robust evaluation strategy for surgical innovations, even if these are often opposed to drug innovations. The aim of this study is to investigate the anthropological, socio-cultural and psychological differences of surgeons that influence the evaluation of surgical innovations.

Study Overview

Status

Recruiting

Conditions

Detailed Description

RESEARCH HYPOTHESIS Over the past decade, the role of the surgeon in scientific research in oncology has evolved and many surgeons are involved in basic research activities alongside their clinical activities. Despite this increasing involvement in research, the issue of evaluation of surgical procedures remains a major concern. As an example, the French Society of Oncological Surgery programs at its annual congress a plenary session "Randomized trial: the grail in oncological surgery?". When the topic of clinical research is discussed, one of the first reactions is usually to point out the differences between research on new therapies and on surgical procedures. This persistent claim can be challenged. This claim may also be related to the major difference in regulation between therapeutics (MA) and medical devices (CE markings) which may not have encouraged surgeons to develop the culture of randomised evidence.

No study seems to evaluate the factors related to the surgeon influencing his involvement and participation in clinical research in oncological surgery. The aim of our study is to determine which anthropo-sociological factors in surgeons are associated with the obstacles to the evaluation of surgical innovations and influence their degree of participation in clinical research.

OBJECTIVES OF THE STUDY The main objective of this study is to evaluate the factors associated with the obstacles to the evaluation of surgical innovations.

The secondary objectives are :

  • To identify the factors associated with involvement in clinical research on two levels : (i) Investigator coordinator, (ii) Investigator in a study.
  • To assess knowledge of complementary designs to the randomised trial.
  • To identify the parameters associated with 'knowledge' of the complementary regimens to the randomised trial.

STUDY DESIGN This is a prospective study conducted on a national scale in the form of a survey of surgeons working in cancerology. This project has obtained the support of UNICANCER (Federation of Cancer Centres), the French-speaking Society of Oncological Surgery (SFCO), the Head and Neck Tumour Study Group (GETTEC), the French Society of Cervico-facial Carcinology (SFCCF), French Society of Gynecology Oncology (SFOG), French Association of Digestive & Visceral Surgery and the French Society of Thoracic and Cardiovascular Surgery. Their mailings will be used to disseminate the survey to surgeons in the area.

STUDY PROCESS

Phase 1: Questionnaire creation

The first part of the project will consist in the creation of the questionnaire. The questionnaire will include data related to the surgeon (non-exhaustive list):

  • Demography: age, gender
  • Education :
  • Place and date of graduation from medical school,
  • Obtained DESC in oncology or European equivalent
  • Practice :
  • Speciality: senology, gynaecology,...
  • Main place of practice: CHU, CLCC, CHG, Private clinic, ESPIC outside CLCC, Other,
  • Number of treated patients per year.
  • Involvement in clinical research:
  • Accreditation to GCP Validated,
  • Number of trials as Coordinating Investigator / Principal Investigator,
  • Number of patients included in a clinical trial per year,
  • Member of a learned society or cooperative group,

Questions associated with barriers to conducting trials in surgery and alternative methodological approaches will be drafted.

Practitioners' attitudes towards risk and uncertainty will be assessed by the following tools:

  1. Questions on willingness to take risk in general and in different areas (answers given on a scale of 0-10).
  2. Questions on the willingness to engage in risky activities in different areas (answers given on a scale of 0-10).
  3. Choice of lotteries : choice between 6 lotteries characterised by different payoffs and risk levels.

In order to check the feasibility, the online questionnaire will be evaluated by the steering committee. The steering committee will include members from the sponsoring centre but also external members who will not be involved in the creation of the questionnaire. Once the questionnaire has been developed, the regulatory steps will be taken.

Phase 2: Awareness raising In this type of study, one of the key points is the response to the questionnaires. In order to mobilise a maximum of surgeons, actions (presentation, Webinar) will be carried out with the different groups/companies that have agreed to participate in the projects.

Phase 3: Sending of questionnaires The questionnaires will be sent to the different surgeons via the Sphynx survey software. This software allows the distribution of dynamic and interactive questionnaires with a display adapted to different media (computer, tablet, smartphone, etc.).

STATISTICAL METHODOLOGY Number of participants needed In two previous studies with a similar methodology, a response rate with usable questionnaires of 17 to 30% was observed, corresponding to 200 and 230 questionnaires. With 200 usable questionnaires and assuming that for 50% of them, obstacles to the evaluation of surgical innovations are identified, it is possible to carry out a multivariable model with 12 parameters according to the rule of thumb of 10 events per variable.

Statistical analysis Demographic data will be described by the usual descriptive statistics. Categorical variables will be presented as follows: number of missing data, number and percentage for each modality of the variable. Quantitative data will be presented as follows: median, minimum, maximum, number of missing data.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Toulouse, France, 31059
        • Recruiting
        • Institut Claudius Regaud
        • Contact:
        • Contact:
          • Morgane Marcou du Tillet de Villars
          • Phone Number: +33(0)531155805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Surgeon practising oncology in France.

Description

Inclusion Criteria:

  • Surgeon practising oncology in France.
  • E-mail address accessible via one of the companies/cooperating groups that have agreed to participate in the project

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of the parameters associated with barriers to the evaluation of surgical innovations.
Time Frame: 21 months

Logistic regression modelling will be carried out to identify the parameters associated with barriers to the evaluation of surgical innovations.

The odds ratios will be estimated with their 95% confidence intervals. In accordance with the recommendations of the literature, a top-down stepwise procedure will be performed for the selection of variables.
21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of the parameters associated with involvement in clinical research.
Time Frame: 21 months

Logistic regression modelling will be carried out to identify the parameters associated with involvement in clinical research.

The odds ratios will be estimated with their 95% confidence intervals. In accordance with the recommendations of the literature, a top-down stepwise procedure will be performed for the selection of variables.
21 months
Identification of the parameters associated with knowledge of complementary patterns.
Time Frame: 21 months
Knowledge of complementary patterns to the randomised trial will be presented using standard descriptive statistics. A similar strategy to the analysis of the primary objective will be used to identify parameters associated with knowledge of complementary patterns.
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

West Cancerology Institute, France
Toulouse Capitole University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

February 14, 2024

Study Completion (Estimated)

December 13, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22RD14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe