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

Carcinoma, Basal Cell, Malignant Clinical Trial

— PSYCHO-CBC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124796
• Other study ID #: CHUBX 2018/16
• Status: Completed
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: November 12, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Basal Cell, Malignant

Intervention

Other:
• Semi-structured interviews
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.

Locations

Country	Name	City	State
France	Service de Dermatologie - Hôpital Saint André	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Bordeaux Population Health Research centre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of "psycho-social factors" that chair the decision-making to consul	semi-structured interviews of patients by the psychologist	Day 1