Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department

Surgical Incision Clinical Trial

— VECUCHIR  

Official title:

Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336371
• Other study ID #: CHUBX 2019/46
• Status: Completed
• Start date: May 28, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The main objective of the study is to explore patients' experience assessing anxiety before, during and away from surgery. The investigators will distinguish the anxiety related to the surgical act itself and the anxiety related to the announcement of the disease.

The secondary objective is to assess the impact of surgery on quality of life, self-image and aesthetic satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 year-old

• Skin cancer on the face ((malignant lentigo, basal cell carcinoma and squamous cell carcinoma) for which a surgical treatment is proposed and will be performed in the Dermatology unit of the University Hospital (CHU) de Bordeaux

• Surgical procedure under local anesthesia

• Patient affiliated to Health Insurance

• Patients will sign consent after reading the information sheet explaining the objectives of the study.

Exclusion Criteria:

• Patients not able to complete the self-assessment questionnaires (difficulties for understanding or reading)

• Patient for whom there was no pre-op consultation in the center

• Patient for whom follow-up will not be possible in the center (because of remoteness for example)

Related Conditions & MeSH terms

• Skin Cancer Face
• Skin Neoplasms
• Surgical Incision
• Surgical Wound

Intervention

Diagnostic Test:
• Self-administered questionnaires
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).

Locations

Country	Name	City	State
France	Hôpital Saint-André - CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (12)

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. Epub 2004 Nov 25. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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