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Skin Cancer FaceVECUCHIRNCT04336371

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

An observational study of Skin Cancer Face and Surgical Incision, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Cancer Face, Surgical Incision
What is being tested?
Self-administered questionnaires
How many people
98 participants
Where
1 siteFrance
Study dates
28 May 2020to 20 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with skin cancer on the face ((malignant lentigo, basal cell carcinoma and squamous cell carcinoma) for which a surgical treatment

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Saint-André - CHU de Bordeaux

    Bordeaux, 33000

Other trials in France

About this study

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.

Read the 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.

Being tested
Self-administered questionnaires
Keywords
surgical, act- quality of life
Medical subject headings
Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-administered questionnairesDiagnostic 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).

Study groups in NCT04336371
Study groupRoleWhat they receive
Anxiety levelpatient's psychological experience the anxiety level
Receives: Diagnostic Test: Self-administered questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. 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

    Measured: Day 10

  3. 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

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start28 May 2020
  3. Primary completion20 Sep 2021
  4. Study completion20 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04336371
Sponsor's protocol ID
CHUBX 2019/46
Acronym
VECUCHIR
Status last verified
Oct 2021
First submitted
31 Mar 2020
Last updated
27 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. doi: 10.1016/j.ijnurstu.2004.09.014. Epub 2004 Nov 25.

    PubMed 15921983

  • 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.

    PubMed 22500906

  • 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. doi: 10.1034/j.1399-6576.2001.045003298.x.

    PubMed 11207465

  • 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.

    PubMed 24572639

  • 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. doi: 10.1097/00000542-200103000-00009.

    PubMed 11374599

  • 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.

    PubMed 26829634

  • 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. doi: 10.1097/00000539-200003000-00036.

    PubMed 10702461

  • 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.

    PubMed 29654700

  • 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.

    PubMed 23102770

  • 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.

    PubMed 30963614

  • 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. doi: 10.1111/j.1524-4725.2004.30169.x.

    PubMed 15056143

  • 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. doi: 10.1097/01.prs.0000172982.43599.d6.

    PubMed 16079683

Questions about this trial

What is this clinical trial studying?

An observational study of Skin Cancer Face and Surgical Incision, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the patient's psychological experience in terms of anxiety, cosmetics and social aspects of surgery (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04336371, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.

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