Clinical trial NCT03663985: FALCOn (Facteur AnthropoLogique Cancer Orl)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Head and Neck Carcinoma
Keywords: head and neck squamous cell carcinoma
surgery
anthropology
sociology
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
Collaborators: name: Onco-Occitanie (Toulouse)
name: University Hospital, Caen
name: Centre Francois Baclesse
First posted: 2018-09-10
Enrollment: 206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: 2018, September to December
Secondary outcomes:
measure: Determination of clinical recommendations choices of the health practitioners for different clinical cases of aerodigestive carcinomas
timeFrame: 2018, September to December
measure: Self assessment of willingness to take risk (by health practitioners themselves)
timeFrame: 2018, September to December
measure: Evaluation of health practitioners' risk attitude
timeFrame: 2018, September to December
measure: Evaluation of health practitioners' uncertainty attitude
timeFrame: 2018, September to December
measure: Evaluation of health practitioners' rationality attitude
timeFrame: 2018, September to December
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud
state: Occitanie
Study officials:
affiliation: Institut Claudius Regaud
name: Agnès DUPRET-BORIES, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.