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

Completed

• Conditions: Surgical Incision; Skin Cancer Face
• Interventions: Diagnostic Test: Self-administered questionnaires

• Registration Number: NCT04336371
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Study Start: 2020-05-28
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anxiety level	Self-administered questionnaires	patient's psychological experience the anxiety level

Primary Outcome Measures

Name	Time	Method
Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery	Month 3	Self-assessment questionnaires will be given to the patient

Trial Locations

Locations (1)

Hôpital Saint-André - CHU de Bordeaux; 🇫🇷 Bordeaux, France