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CompletedNCT03663985FALCOnUpdated Mar 3, 2020

FALCOn (Facteur AnthropoLogique Cancer Orl)

An observational study in Head and Neck Cancer and Head and Neck Carcinoma, sponsored by Institut Claudius Regaud. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by Institut Claudius Regaud · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
206
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Head and Neck Cancer
  • Head and Neck Carcinoma

Keywords

  • head and neck squamous cell carcinoma
  • surgery
  • anthropology
  • sociology
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.

This study's enrollment of 206 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
206 participants (actual)
Patient registry
No

Interventions

  • OtherGroupe 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.

06

What researchers measure

Primary outcomes

  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.

    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

    Time frame: 2018, September to December

Secondary outcomes

  1. Determination of clinical recommendations choices of the health practitioners for different clinical cases of aerodigestive carcinomas

    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.

    Time frame: 2018, September to December

  2. Self assessment of willingness to take risk (by health practitioners themselves)

    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"

    Time frame: 2018, September to December

  3. Evaluation of health practitioners' risk attitude

    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).

    Time frame: 2018, September to December

  4. Evaluation of health practitioners' uncertainty attitude

    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.

    Time frame: 2018, September to December

  5. Evaluation of health practitioners' rationality attitude

    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.

    Time frame: 2018, September to December

07

Study locations

1 site
  • Institut Claudius Regaud
    Toulouse, Occitanie 31059, France
08

References and documents

Publications

  • Krahenmann-Muller S, Virgini VS, Blum MR, da Costa BR, Collet TH, Martin Y, Cornuz J, Zimmerli L, Gaspoz JM, Bauer DC, Kerr EA, Aujesky D, Rodondi N. Patient and physician gender concordance in preventive care in university primary care settings. Prev Med. 2014 Oct;67:242-7. doi: 10.1016/j.ypmed.2014.08.004. Epub 2014 Aug 10. PubMed 25117521 ↗
  • Andersen MR, Urban N. Physician gender and screening: do patient differences account for differences in mammography use? Women Health. 1997;26(1):29-39. doi: 10.1300/J013v26n01_03. PubMed 9311098 ↗
  • Franks P, Clancy CM. Physician gender bias in clinical decisionmaking: screening for cancer in primary care. Med Care. 1993 Mar;31(3):213-8. doi: 10.1097/00005650-199303000-00003. PubMed 8450679 ↗
  • Frank E, Harvey LK. Prevention advice rates of women and men physicians. Arch Fam Med. 1996 Apr;5(4):215-9. doi: 10.1001/archfami.5.4.215. PubMed 8769910 ↗
  • Arrington AK, Jarosek SL, Virnig BA, Habermann EB, Tuttle TM. Patient and surgeon characteristics associated with increased use of contralateral prophylactic mastectomy in patients with breast cancer. Ann Surg Oncol. 2009 Oct;16(10):2697-704. doi: 10.1245/s10434-009-0641-z. Epub 2009 Aug 4. PubMed 19653045 ↗
  • Tsugawa Y, Jena AB, Figueroa JF, Orav EJ, Blumenthal DM, Jha AK. Comparison of Hospital Mortality and Readmission Rates for Medicare Patients Treated by Male vs Female Physicians. JAMA Intern Med. 2017 Feb 1;177(2):206-213. doi: 10.1001/jamainternmed.2016.7875. PubMed 27992617 ↗
  • Mehrotra A, Reid RO, Adams JL, Friedberg MW, McGlynn EA, Hussey PS. Physicians with the least experience have higher cost profiles than do physicians with the most experience. Health Aff (Millwood). 2012 Nov;31(11):2453-63. doi: 10.1377/hlthaff.2011.0252. PubMed 23129676 ↗
  • Meier P, Duvernoy CS. Influence of gender of physicians and patients on guideline-recommended treatment of chronic heart failure in a cross-sectional study. Eur J Heart Fail. 2009 Jun;11(6):631; author reply 631-2. doi: 10.1093/eurjhf/hfp056. Epub 2009 Apr 27. No abstract available. PubMed 19398490 ↗
  • Berthold HK, Gouni-Berthold I, Bestehorn KP, Bohm M, Krone W. Physician gender is associated with the quality of type 2 diabetes care. J Intern Med. 2008 Oct;264(4):340-50. doi: 10.1111/j.1365-2796.2008.01967.x. Epub 2008 Apr 4. PubMed 18397244 ↗
  • Reid RO, Friedberg MW, Adams JL, McGlynn EA, Mehrotra A. Associations between physician characteristics and quality of care. Arch Intern Med. 2010 Sep 13;170(16):1442-9. doi: 10.1001/archinternmed.2010.307. PubMed 20837830 ↗
  • Schieber AC, Delpierre C, Lepage B, Afrite A, Pascal J, Cases C, Lombrail P, Lang T, Kelly-Irving M; INTERMEDE group. Do gender differences affect the doctor-patient interaction during consultations in general practice? Results from the INTERMEDE study. Fam Pract. 2014 Dec;31(6):706-13. doi: 10.1093/fampra/cmu057. Epub 2014 Sep 11. PubMed 25214508 ↗
  • 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.
  • Chabrillac E, Lamy S, Grosclaude P, Cros F, Vairel B, Sarini J, Vergez S, Nebout A, Bories P, Dupret-Bories A. The impact of physician's characteristics on decision-making inhead and neck oncology: Results of a national survey. Oral Oncol. 2022 Jun;129:105895. doi: 10.1016/j.oraloncology.2022.105895. Epub 2022 Apr 29. PubMed 35500434 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03663985
Lead sponsor
Institut Claudius Regaud
Collaborators
Onco-Occitanie (Toulouse), University Hospital, Caen, Centre Francois Baclesse
Responsible party
Sponsor
First posted
Sep 10, 2018
Start date
Sep 15, 2018
Primary completion
Dec 31, 2018
Completion
May 31, 2019
Last update
Mar 3, 2020

Study contacts

Agnès DUPRET-BORIES, PhD
principal investigator · Institut Claudius Regaud

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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