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

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

Sponsors

Lead sponsor: University Hospital, Bordeaux

Collaborator: Bordeaux Population Health Research centre

Source University Hospital, Bordeaux
Brief 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.

Detailed 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

Overall Status Completed
Start Date November 12, 2018
Completion Date November 12, 2019
Primary Completion Date November 12, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of "psycho-social factors" that chair the decision-making to consul Day 1
Enrollment 29
Condition
Intervention

Intervention type: Other

Intervention name: Semi-structured interviews

Description: 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.

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Marie BEYLOT BARRY, MD, PhD Principal Investigator University Hospital, Bordeaux
Location
facility Service de Dermatologie - Hôpital Saint André
Location Countries

France

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: target subjects

Arm group type: Experimental

Description: "target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit.

Arm group label: health care team

Arm group type: Active Comparator

Description: the health care team managing these patients

Acronym PSYCHO-CBC
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: Fifteen to twenty "target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit.
Fifteen members of the health care team managing these patients

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov