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FALCOn (Facteur AnthropoLogique Cancer Orl) (FALCOn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663985
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborators:
Onco-Occitanie (Toulouse)
University Hospital, Caen
Centre Francois Baclesse
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Head and Neck Carcinoma Other: Groupe FALCOn

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.

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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : September 15, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : May 31, 2019

Intervention Details:
  • Other: Groupe FALCOn
    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 ENT carcinology.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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"

  3. 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).

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663985


Locations
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France
Institut Claudius Regaud
Toulouse, Occitanie, France, 31059
Sponsors and Collaborators
Institut Claudius Regaud
Onco-Occitanie (Toulouse)
University Hospital, Caen
Centre Francois Baclesse
Investigators
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Principal Investigator: Agnès DUPRET-BORIES, PhD Institut Claudius Regaud
Publications of Results:
Allais, M. (1953). L'extension des théories de l'équilibre économique général et du rendement social au cas du risque. Econometrica, Journal of the Econometric Society, 269-290.

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03663985    
Other Study ID Numbers: 17HLSHS01
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
head and neck squamous cell carcinoma
surgery
anthropology
sociology
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site