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Head and Neck CancerFALCOnNCT03663985

FALCOn (Facteur AnthropoLogique Cancer Orl)

An observational study of Head and Neck Cancer and Head and Neck Carcinoma, run by Institut Claudius Regaud at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Head and Neck Cancer, Head and Neck Carcinoma
What is being tested?
Groupe FALCOn
How many people
206 participants
Where
1 siteFrance
Study dates
15 Sep 2018to 31 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Claudius Regaud

    Toulouse, Occitanie, 31059

Other trials in France

About this study

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

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:
Read more
  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.

Being tested
Groupe FALCOn
Keywords
head and neck squamous cell carcinoma, surgery, anthropology, sociology
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Groupe FALCOnOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2018, September to December

Secondary outcomes (5)

  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.

    Measured: 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"

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 2018, September to December

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2018
  2. Study start15 Sep 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03663985
Sponsor's protocol ID
17HLSHS01
Acronym
FALCOn
Status last verified
Jul 2018
First submitted
20 Jul 2018
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer and Head and Neck Carcinoma, run by Institut Claudius Regaud at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03663985, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

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