FALCOn (Facteur AnthropoLogique Cancer Orl) (FALCOn)

March 2, 2020 updated by: Institut Claudius Regaud

FALCOn (Facteur AnthropoLogique Cancer Orl) Evaluation Des Facteurs Anthropologiques, Socio-culturels et Psychologiques Des Praticiens Qui Conditionnent la Prise de décision Pour Les Patients Atteints de Cancer Des VADS

There are no studies on practitioner-related factors influencing decision-making in the field of carcinology of aerodigestive carcinomas. The objective of the study is to determine what are the anthropo-sociological factors in the surgeon, the oncologists and radiotherapists influencing decision making in ear, nose, and throat carcinology. Special attention will be paid to the practitioner's gender, age, geographical origin, place and institution of training, place of practice, volume of patients treated, access to or without reconstruction by microsurgery, his tendency or aversion to risk taking.

  • Main objectives : To determine the individual professional and non-professional characteristics influencing physicians' decision-making in oncology of aerodigestive carcinomas between choices:

    1. Surgery
    2. Radio and / or chemotherapy
    3. Support care
    4. Neo-adjuvant chemotherapy and reassessment
  • Secondary objectives : Identify if certain patient profiles may lead to heterogeneous treatment decisions i.e. Human Papillomavirus status, age, comorbidities, autonomy, etc.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Actually, there are no studies on practitioner-related factors influencing decision-making in the field of carcinology of aerodigestive carcinomas.

The objective of the study is to determine what are the anthropo-sociological factors in the surgeon, the oncologists and radiotherapists influencing decision making in ear, nose, and throat carcinology.

Special attention will be paid to the practitioner's gender, age, geographical origin, place and institution of training, place of practice, volume of patients treated, access to or without reconstruction by microsurgery, his tendency or aversion to risk taking.

This questionnaire will include the items age, sex, place and date of obtaining a medical degree, whether or not obtaining the specialization in cancer, profession of surgeon / oncologist / radiotherapist, place of practice with type of institution (University hospital, Private clinic, etc.) volume of patients treated per year, access or not to reconstructions by microsurgery. The answers to the questionnaire will be anonymous.

Practitioners' attitudes towards risk and uncertainty will be evaluated by 4 validated tools in behavioral science:

  1. Self-assessment of attitude towards risk in different areas (Likert scale)
  2. Monetary choice when earnings probabilities are known (attitude to risk)
  3. Monetary choice when earnings probabilities are not known (attitude towards uncertainty)
  4. Experience of Allais Seven clinical cases will serve as a basis for the creation of clinical vignettes.

A standard case will be part of these vignettes allowing a validation on the respect of the guidelines. The other 6 clinical cases will be cleavants and 36 vignettes will be created by crossing the 6 previous clinical cases with 6 different patient profiles on their social and demographic characteristics (age, comorbidity, sex, isolation)

The experimental plan will take the form of a Latin Square to propose (in addition to the standard case), 6 vignettes to each practitioner by ensuring that all the factors will be presented in a balanced and random way.

In a first phase, the online questionnaire including the vignettes will be evaluated within the sponsor center and by two ear, nose, and throat surgeons from two other centers who have agreed to participate in the project in order to verify its feasibility before global sending.

Study Type

Observational

Enrollment (Actual)

206

Contacts and Locations

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

Study Locations

  • France
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • Institut Claudius Regaud

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
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Aerodigestive carcinomas surgeons, oncologists specializing in oncology of aerodigestive carcinomas, radiation therapists specialized in oncology of VADS exercising in France. Email addresses accessible via GETTEC / GORTEC / GERCOR / SFORL / UNICANCER.

Description

Inclusion Criteria:

  • Ear, nose and throat surgeons, oncologists specializing in oncology of aerodigestive carcinomas, radiation therapists specialized in oncology of aerodigestive carcinomas exercising in France

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
Evaluation of the anthropological, socio-cultural and psychological factors of the practitioners which condition the decision making for the patients with aero-digestive carcinomas.
Time Frame: 2018, September to December

An analysis using a classification method will define a typology of therapeutic choices given their aggression and potential risk.

These typologies of prescriptions will then be confronted with the characteristics of physicians in terms of propensity for risk taking and their socio-demographic characteristics using a chi2 test (univariate) and a logistic regression (or polynomial if a binary typology cannot be released (multivariate).

Variability of choice and influence of physician characteristics on these choices will also be analyzed based on patient characteristics

Expected results :

  • Impact of socio-professional characteristics on the decision-making in oncology of aerodigestive carcinomas.
  • Impact of psychological factors ie tendency to take risk
2018, September to December

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of clinical recommendations choices of the health practitioners for different clinical cases of aerodigestive carcinomas
Time Frame: 2018, September to December

7 clinical cases will serve as a basis for the creation of clinical vignettes: A standard case (T2N1M0 pelvi-lingual carcinoma, good general condition patient) will be part of these vignettes allowing a validation on the respect of the guidelines.The other 6 clinical cases will be cleavants.

The experimental plan will take the form of a Latin Square to propose (in addition to the standard case), 6 vignettes to each practitioner by ensuring that all the factors will be presented in a balanced and random way.

Practitioners will be asked to give their clinical recommendations for each clinical case presented.
2018, September to December
Self assessment of willingness to take risk (by health practitioners themselves)
Time Frame: 2018, September to December
All the health practitioners will be asked to self-evaluate their propensity to take risk using a 11-point Likert scale ranging from "not at all willing to take risks" to "fully prepared to take risks" in 4 different domains including their daily life, their personal finances, their patient's health and their own health. The Likert scale used in this test is a 0-10 scale where 0 means "not at all willing to take risks" and 10 means "fully prepared to take risks"
2018, September to December
Evaluation of health practitioners' risk attitude
Time Frame: 2018, September to December
Individual attitudes toward risk will be obtained through certainty equivalent elicitation of a lottery. Using a scrollbar, respondents will be asked to provide the amount of money that makes them indifferent between gaining it for sure or playing the lottery giving them 500 euros with half a chance and nothing otherwise. The expected gain of this lottery is 250 euros, so when the elicited certainty equivalent is inferior (equal/superior) to 250 euros, the respondent is considered as risk averse (neutral/seeking).
2018, September to December
Evaluation of health practitioners' uncertainty attitude
Time Frame: 2018, September to December
Individual attitudes towards uncertainty will be obtained through certainty equivalent elicitation of a lottery where the probability of gain is unknown. Using the same scrollbar, respondents will be asked to provide the amount of money that makes them indifferent between gaining it for sure or playing the lottery giving them 500 euros with an unknown probability and nothing with an unknown probability.
2018, September to December
Evaluation of health practitioners' rationality attitude
Time Frame: 2018, September to December

Individual rationality attitudes will be obtained through an Allais test. The expected utility theory is an axiomatic model of decision under uncertainty and is often considered as a normative model of rationality. Allais and Kahneman and Tversky proposed a set of two binary choices that allow to test the independence axiom of the expected utility theory under risk and therefore the adequacy of an individual to the model.

The Allais task will be assessed with this 2 questions:

Choice 1: Which option do you prefer?

  • Option A gives you 100% of chance to win 2000$
  • Option B gives you 80% of chance to win 3000$ and 20% of chance to win 0$ Choice 2: Which option do you prefer?
  • Option C which gives you 25% of chance to win 2000$ and 75% of chance to win 0$
  • Option D which gives you 20% of chance to win 3000$ and 80% of chance to win 0$ Choice pattern AD indicates a violation of rationality. Same line of reasoning applies for the choice pattern BC.
2018, September to December

Collaborators and Investigators

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

Sponsor

Institut Claudius Regaud

Collaborators

University Hospital, Caen
Centre Francois Baclesse
Onco-Occitanie (Toulouse)

Investigators

  • Principal Investigator: Agnès DUPRET-BORIES, PhD, Institut Claudius Regaud

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)

September 15, 2018

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

May 31, 2019

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (ACTUAL)

September 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17HLSHS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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