Anthropological, Socio-cultural and Psychological Surgeons' Factors in Oncology and Brakes for Evaluation of Innovations

NCT05865964 | Recruiting

• 1 other identifier: 22RD14
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The field of surgery continues to benefit from innovative solutions, changing surgical methods and techniques. Evaluation in terms of efficacy and Quality-Safety is an essential topic that directly affects the introduction of innovations. It is essential to carry out a robust evaluation strategy for surgical innovations, even if these are often opposed to drug innovations. The aim of this study is to investigate the anthropological, socio-cultural and psychological differences of surgeons that influence the evaluation of surgical innovations.

Conditions

Surgery

Keywords

Medical Care; clinical trial; innovation; breaks; surgeons; oncology

Outcome Measures

Primary Outcomes (1)

• Identification of the parameters associated with barriers to the evaluation of surgical innovations.

  Logistic regression modelling will be carried out to identify the parameters associated with barriers to the evaluation of surgical innovations. The odds ratios will be estimated with their 95% confidence intervals. In accordance with the recommendations of the literature, a top-down stepwise procedure will be performed for the selection of variables.

  21 months

Secondary Outcomes (2)

• Identification of the parameters associated with involvement in clinical research.

  21 months

• Identification of the parameters associated with knowledge of complementary patterns.

  21 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgeon practising oncology in France.

You may qualify if:

• Surgeon practising oncology in France.
• E-mail address accessible via one of the companies/cooperating groups that have agreed to participate in the project

You may not qualify if:

• None

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• West Cancerology Institute, France: collaborator
• Toulouse Capitole University: collaborator

Study Sites (1)

Institut Claudius Regaud

Toulouse, 31059, France

RECRUITING

Related Publications (33)

• Bories P, Lamy S, Simand C, Bertoli S, Delpierre C, Malak S, Fornecker L, Moreau S, Recher C, Nebout A. Physician uncertainty aversion impacts medical decision making for older patients with acute myeloid leukemia: results of a national survey. Haematologica. 2018 Dec;103(12):2040-2048. doi: 10.3324/haematol.2018.192468. Epub 2018 Jul 13.

  PMID: 30006448 BACKGROUND

• Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, "SVEA," comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg. 2000 Jan;105(1):66-74; discussion 75-6. doi: 10.1097/00006534-200001000-00011.

  PMID: 10626972 BACKGROUND

• Castel P, Negrier S, Boissel JP; Plateforme d'Aide a la Recherche Clinique en Cancerologie de la region Rhone-Alpes. Why don't cancer patients enter clinical trials? A review. Eur J Cancer. 2006 Aug;42(12):1744-8. doi: 10.1016/j.ejca.2005.10.033. Epub 2006 Jun 14.

  PMID: 16777404 BACKGROUND

• Concato J, Peduzzi P, Holford TR, Feinstein AR. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol. 1995 Dec;48(12):1495-501. doi: 10.1016/0895-4356(95)00510-2.

  PMID: 8543963 BACKGROUND

• Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009 Feb 6;10:9. doi: 10.1186/1745-6215-10-9.

  PMID: 19200379 BACKGROUND

• Crocker JC, Farrar N, Cook JA, Treweek S, Woolfall K, Chant A, Bostock J, Locock L, Rees S, Olszowski S, Bulbulia R. Recruitment and retention of participants in UK surgical trials: survey of key issues reported by trial staff. BJS Open. 2020 Oct 4;4(6):1238-45. doi: 10.1002/bjs5.50345. Online ahead of print.

  PMID: 33016008 BACKGROUND

• Cros F, Lamy S, Grosclaude P, Nebout A, Chabrillac E, Vergez S, Bories P, Dupret-Bories A. Physician practice variation in head and neck cancer therapy: Results of a national survey. Oral Oncol. 2021 Jun;117:105293. doi: 10.1016/j.oraloncology.2021.105293. Epub 2021 Apr 14.

  PMID: 33862559 BACKGROUND

• Elliott D, Hamdy FC, Leslie TA, Rosario D, Dudderidge T, Hindley R, Emberton M, Brewster S, Sooriakumaran P, Catto JWF, Emara A, Ahmed H, Whybrow P, le Conte S, Donovan JL. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. BJU Int. 2018 Dec;122(6):970-977. doi: 10.1111/bju.14432. Epub 2018 Aug 15.

  PMID: 29888845 BACKGROUND

• Evrard S, McKelvie-Sebileau P, van de Velde C, Nordlinger B, Poston G. What can we learn from oncology surgical trials? Nat Rev Clin Oncol. 2016 Jan;13(1):55-62. doi: 10.1038/nrclinonc.2015.176. Epub 2015 Oct 20.

  PMID: 26483296 BACKGROUND

• Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.

  PMID: 25460338 BACKGROUND

• Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

  PMID: 29608972 BACKGROUND

• Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, Deutsch M, Schwarz G, Margolese R, Donegan W, Volk H, Konvolinka C, Gardner B, Cohn I Jr, Lesnick G, Cruz AB, Lawrence W, Nealon T, Butcher H, Lawton R. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer. 1977 Jun;39(6 Suppl):2827-39. doi: 10.1002/1097-0142(197706)39:63.0.co;2-i. No abstract available.

  PMID: 326381 BACKGROUND

• Ford E, Jenkins V, Fallowfield L, Stuart N, Farewell D, Farewell V. Clinicians' attitudes towards clinical trials of cancer therapy. Br J Cancer. 2011 May 10;104(10):1535-43. doi: 10.1038/bjc.2011.119. Epub 2011 Apr 12.

  PMID: 21487408 BACKGROUND

• Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.

  PMID: 20739842 BACKGROUND

• Goyal A, Dodwell D. POSNOC: A Randomised Trial Looking at Axillary Treatment in Women with One or Two Sentinel Nodes with Macrometastases. Clin Oncol (R Coll Radiol). 2015 Dec;27(12):692-5. doi: 10.1016/j.clon.2015.07.005. Epub 2015 Aug 5. No abstract available.

  PMID: 26254841 BACKGROUND

• Goyal A, Mann GB, Fallowfield L, Duley L, Reed M, Dodwell D, Coleman RE, Fakis A, Newcombe R, Jenkins V, Whitham D, Childs M, Whynes D, Keeley V, Ellis I, Fairbrother P, Sadiq S, Monson K, Montgomery A, Tan W, Vale L, Homer T, Badger H, Haines RH, Lewis M, Megias D, Nabi Z, Singh P, Caraman A, Miles E; POSNOC Trialists. POSNOC-POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy: a randomised controlled trial of axillary treatment in women with early-stage breast cancer who have metastases in one or two sentinel nodes. BMJ Open. 2021 Dec 2;11(12):e054365. doi: 10.1136/bmjopen-2021-054365.

  PMID: 34857578 BACKGROUND

• Gray S, Price C. Barriers to participation in randomised controlled trials. J Clin Epidemiol. 2001 Mar;54(3):323-4. doi: 10.1016/s0895-4356(00)00279-1. No abstract available.

  PMID: 11243239 BACKGROUND

• Halsted WS. I. A Clinical and Histological Study of certain Adenocarcinomata of the Breast: and a Brief Consideration of the Supraclavicular Operation and of the Results of Operations for Cancer of the Breast from 1889 to 1898 at the Johns Hopkins Hospital. Ann Surg. 1898 Nov;28(5):557-76. No abstract available.

  PMID: 17860646 BACKGROUND

• Hirst A, Agha RA, Rosin D, McCulloch P. How can we improve surgical research and innovation?: the IDEAL framework for action. Int J Surg. 2013;11(10):1038-42. doi: 10.1016/j.ijsu.2013.09.016. Epub 2013 Oct 7. No abstract available.

  PMID: 24113195 BACKGROUND

• Jones RP, Are C, Hugh TJ, Grunhagen DJ, Xu J, Balch CM, Poston GJ. Reshaping the critical role of surgeons in oncology research. Nat Rev Clin Oncol. 2019 May;16(5):327-332. doi: 10.1038/s41571-018-0149-1.

  PMID: 30617343 BACKGROUND

• McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.

  PMID: 19782876 BACKGROUND

• McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999 Dec;23(12):1210-4. doi: 10.1007/s002689900649.

  PMID: 10552108 BACKGROUND

• Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. External control arms in oncology: current use and future directions. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10.

  PMID: 35026413 BACKGROUND

• Moons KG, Altman DG, Reitsma JB, Ioannidis JP, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015 Jan 6;162(1):W1-73. doi: 10.7326/M14-0698.

  PMID: 25560730 BACKGROUND

• Nakamura S. Axillary lymph node dissection in sentinel node positive breast cancer: is it necessary? Curr Opin Obstet Gynecol. 2013 Feb 19. doi: 10.1097/GCO.0b013e32834f3608. Online ahead of print.

  PMID: 23425664 BACKGROUND

• Potter S, Mills N, Cawthorn SJ, Donovan J, Blazeby JM. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials. 2014 Mar 14;15:80. doi: 10.1186/1745-6215-15-80.

  PMID: 24628821 BACKGROUND

• Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999 Dec;52(12):1143-56. doi: 10.1016/s0895-4356(99)00141-9.

  PMID: 10580777 BACKGROUND

• Schroen AT, Brenin DR. Breast cancer treatment beliefs and influences among surgeons in areas of scientific uncertainty. Am J Surg. 2010 Apr;199(4):491-9. doi: 10.1016/j.amjsurg.2009.04.005.

  PMID: 20359569 BACKGROUND

• Spillane AJ, Mann GB. Surgeon knows best versus breast cancer surgical clinical trial equipoise: a plea for the sake of future trials. ANZ J Surg. 2017 Mar;87(3):111-112. doi: 10.1111/ans.13831. No abstract available.

  PMID: 28253558 BACKGROUND

• Taylor KM, Margolese RG, Soskolne CL. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med. 1984 May 24;310(21):1363-7. doi: 10.1056/NEJM198405243102106.

  PMID: 6717508 BACKGROUND

• Tibau A, Molto C, Borrell M, Del Paggio JC, Barnadas A, Booth CM, Amir E. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials. JAMA Oncol. 2018 Nov 1;4(11):1610-1611. doi: 10.1001/jamaoncol.2018.4300.

  PMID: 30267037 BACKGROUND

• Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015 Jan 8;372(2):134-41. doi: 10.1056/NEJMoa1406281.

  PMID: 25564897 BACKGROUND

• Unger JM, Hershman DL, Till C, Minasian LM, Osarogiagbon RU, Fleury ME, Vaidya R. "When Offered to Participate": A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. doi: 10.1093/jnci/djaa155.

  PMID: 33022716 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Charline Berthier, MD

CONTACT

+33(0)531155397; Berthier.Charline@iuct-oncopole.fr

Thomas Filleron, PhD

CONTACT

+33(0)531155865; filleron.thomas@iuct-oncopole.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: December 14, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 13, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)