NCT04336371|Completed
Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department
VECUCHIR
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VECUCHIR
Sponsor study identifier
observational
98
1 country
1
Study Start
May 28, 2020
Actual (reported)Primary Completion
September 20, 2021
Actual (reported)Study Completion
September 20, 2021
Actual (reported)Surgery is the first-line treatment of localized skin cancers. Knowledge on the patient's psychological experience is limited. Therefore, the psychological impact on patients before, during and after surgery can be underestimated. Moreover, the diagnosis of cancer disturbs the patient's entire life and the onset of anxiety disorders is frequent following this announcement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2020
Actual (reported)April 7, 2020
Actual (reported)May 28, 2020
Actual (reported)September 20, 2021
Actual (reported)September 20, 2021
Actual (reported)Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery
Self-assessment questionnaires will be given to the patient
Day 1
Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery
Self-assessment questionnaires will be given to the patient
Day 10
Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery
Self-assessment questionnaires will be given to the patient
Month 3
patient's psychological experience the anxiety level
Self-administered questionnaires by the patient will be given during visits in the following order:the self-administered questionnaires concerning the announcement consultation will be completed by the patient after consultation waiting room; self-questionnaires will be given in just before the operation waiting room (D0) just before the suture removal points (J10) and just before the follow-up visit (M3).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with skin cancer on the face ((malignant lentigo, basal cell carcinoma and squamous cell carcinoma) for which a surgical treatment
Hôpital Saint-André - CHU de Bordeaux
Bordeaux, 33000, France
Carr EC, Nicky Thomas V, Wilson-Barnet J. Patient experiences of anxiety, depression and acute pain after surgery: a longitudinal perspective. Int J Nurs Stud. 2005 Jul;42(5):521-30. doi: 10.1016/j.ijnurstu.2004.09.014. Epub 2004 Nov 25.
Matthias AT, Samarasekera DN. Preoperative anxiety in surgical patients - experience of a single unit. Acta Anaesthesiol Taiwan. 2012 Mar;50(1):3-6. doi: 10.1016/j.aat.2012.02.004. Epub 2012 Mar 30.
Marie BEYLOT-BARRY, MD, PhD
University Hospital, Bordeaux
98 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2020
First Posted
April 7, 2020
Study Start
May 28, 2020
Actual (reported)A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life
Contact the study team to confirm eligibility.
Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.
Reddi D, Curran N. Chronic pain after surgery: pathophysiology, risk factors and prevention. Postgrad Med J. 2014 Apr;90(1062):222-7; quiz 226. doi: 10.1136/postgradmedj-2013-132215. Epub 2014 Feb 26.
Kain ZN, Sevarino FB, Rinder C, Pincus S, Alexander GM, Ivy M, Heninger G. Preoperative anxiolysis and postoperative recovery in women undergoing abdominal hysterectomy. Anesthesiology. 2001 Mar;94(3):415-22. doi: 10.1097/00000542-200103000-00009.
Gaudry E, Vagg P, Spielberger CD. Validation of the State-Trait Distinction in Anxiety Research. Multivariate Behav Res. 1975 Jul 1;10(3):331-41. doi: 10.1207/s15327906mbr1003_6.
Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
Lee EH, Klassen AF, Cano SJ, Nehal KS, Pusic AL. FACE-Q Skin Cancer Module for measuring patient-reported outcomes following facial skin cancer surgery. Br J Dermatol. 2018 Jul;179(1):88-94. doi: 10.1111/bjd.16671. Epub 2018 May 23.
Lee EH, Klassen AF, Nehal KS, Cano SJ, Waters J, Pusic AL. A systematic review of patient-reported outcome instruments of nonmelanoma skin cancer in the dermatologic population. J Am Acad Dermatol. 2013 Aug;69(2):e59-67. doi: 10.1016/j.jaad.2012.09.017. Epub 2012 Oct 24.
Chernyshov PV, Lallas A, Tomas-Aragones L, Arenbergerova M, Samimi M, Manolache L, Svensson A, Marron SE, Sampogna F, Spillekom-vanKoulil S, Bewley A, Forsea AM, Jemec GB, Szepietowski JC, Augustin M, Finlay AY. Quality of life measurement in skin cancer patients: literature review and position paper of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient Oriented Outcomes, Melanoma and Non-Melanoma Skin Cancer. J Eur Acad Dermatol Venereol. 2019 May;33(5):816-827. doi: 10.1111/jdv.15487. Epub 2019 Apr 8.
Rhee JS, Matthews BA, Neuburg M, Smith TL, Burzynski M, Nattinger AB. Skin cancer and quality of life: assessment with the Dermatology Life Quality Index. Dermatol Surg. 2004 Apr;30(4 Pt 1):525-9. doi: 10.1111/j.1524-4725.2004.30169.x.
van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
Primary Completion
September 20, 2021
Actual (reported)Study Completion
September 20, 2021
Actual (reported)Last Updated
October 27, 2021
Record last verified: 2021-10
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