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Completed

NCT Number: NCT04124796

Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma

The aim of this study was to identify psycho-social factors associated with diagnostic delay in advanced basal cell carcinomas. Thus, the objective is to develop recommendations to better identify CBCa populations at risk, improve earlier their diagnosis and thus their care with an adequate and targeted information.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Dermatologie - Hôpital Saint André

Bordeaux, 33000, France

About this study

Skin cancers incidence is constantly increasing as a result of ageing of the population, and is then a critical issue of concern. Among skin cancers, basal cell carcinoma is the most common. Its treatment is mainly based on surgery that has to be done early. Indeed, CBC can lead to progressive destruction of tissues and significant morbidity in advanced stages. In these advanced stages (CBCa), they are no longer accessible to surgery or radiation therapy. The recently developed targeted therapies represent a significant therapeutic progress. To date, there are few data -none in France- concerning the cause of diagnostic delay .

Thus, the main goal of this study will be to evidence the brakes and facilitators who chair the decision-making to consult in patients with a CBCa, by investigating:

  • the perception of the target subjects (patients);
  • the perception of the healthcare team; We will also conduct a critical meta-synthesis (qualitative meta-analysis) of the literature concerning the diagnostic delay and decision-making in onco-dermatology.

It is a prospective non-Interventional exploratory qualitative study without direct individual benefit

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients over 18 years of age with a CBCa supported for less than 12 months in the onco-Dermatology unit of the CHU de Bordeaux.
  • Are defined as locally advanced,tumors with major invasion of adjacent structures, that are not accessible for surgical resection or radiotherapy, .
  • Patients will sign a consent after reading the fact sheet explaining the objectives of the study.

Exclusion criteria

  • subjects with severe dementia (mini mental state less than 10)
  • An anonymized list of non-included according to this criterion will be carried out in order to quantify the number of advanced CBC with severe dementia and also the number of refusals.

Treatment and study plan

semi-structured interviews

Other

Based on an interview grid previously built, the interviews will investigate the factors governing the decision to consult and methods of intervention to reduce the time to consult.

Primary outcomes

  1. Proportion of "psycho-social factors" that chair the decision-making to consul

    Time frame: Day 1

    semi-structured interviews of patients by the psychologist

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Bordeaux Population Health Research centre

Registry information

Acronym: PSYCHO-CBC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2019
Registry last updated
Mar 25, 2020

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.

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