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

October 26, 2021 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Hôpital Saint-André - Chu de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anxiety level
patient's psychological experience the anxiety level
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1
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
Day 10
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
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Marie BEYLOT-BARRY, MD, PhD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Actual)

September 20, 2021

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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