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

Surgery Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865964
• Other study ID #: 22RD14
• Status: Recruiting
• Start date: December 14, 2022
• Est. completion date: December 13, 2024

Study information

• Verified date: May 2023
• Source: Institut Claudius Regaud
• Contact: Charline Berthier, MD
• Phone: +33(0)531155397
• Email: Berthier.Charline[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 13, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Surgery

Locations

Country	Name	City	State
France	Institut Claudius Regaud	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Toulouse Capitole University, West Cancerology Institute, France

Country where clinical trial is conducted

France, 

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the parameters associated with barriers to the evaluation of surgical innovations.	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	Identification of the parameters associated with involvement in clinical research.	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
Secondary	Identification of the parameters associated with knowledge of complementary patterns.	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