Clinical trial NCT04336371: Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department
Official title: Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer Face
Surgical Incision
Keywords: surgical
act- quality of life
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with skin cancer on the face ((malignant lentigo, basal cell carcinoma and squamous cell carcinoma) for which a surgical treatment

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery
timeFrame: Day 1
measure: Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery
timeFrame: Day 10
measure: Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint-André - CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Marie BEYLOT-BARRY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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