Skip to main content
OpenTrials
Completed

NCT Number: NCT04336371

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-André - CHU de Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Self-administered questionnaires

Diagnostic Test

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).

Primary outcomes

  1. Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery

    Time frame: Day 1

    Self-assessment questionnaires will be given to the patient

  2. Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery

    Time frame: Day 10

    Self-assessment questionnaires will be given to the patient

  3. Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery

    Time frame: Month 3

    Self-assessment questionnaires will be given to the patient

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: VECUCHIR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2020
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.