Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma (PSYCHO-CBC)
Primary Purpose
Carcinoma, Basal Cell, Malignant
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Semi-structured interviews
Sponsored by
About this trial
This is an interventional other trial for Carcinoma, Basal Cell, Malignant focused on measuring Carcinoma, Basal Cell, psycho-social factors
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.
Sites / Locations
- Service de Dermatologie - Hôpital Saint André
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
target subjects
health care team
Arm Description
"target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit.
the health care team managing these patients
Outcomes
Primary Outcome Measures
Proportion of "psycho-social factors" that chair the decision-making to consul
semi-structured interviews of patients by the psychologist
Secondary Outcome Measures
Full Information
NCT ID
NCT04124796
First Posted
October 10, 2019
Last Updated
March 24, 2020
Sponsor
University Hospital, Bordeaux
Collaborators
Bordeaux Population Health Research centre
1. Study Identification
Unique Protocol Identification Number
NCT04124796
Brief Title
Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma
Acronym
PSYCHO-CBC
Official Title
Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Bordeaux Population Health Research centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell, Malignant
Keywords
Carcinoma, Basal Cell, psycho-social factors
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
target subjects
Arm Type
Experimental
Arm Description
"target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit.
Arm Title
health care team
Arm Type
Active Comparator
Arm Description
the health care team managing these patients
Intervention Type
Other
Intervention Name(s)
Semi-structured interviews
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of "psycho-social factors" that chair the decision-making to consul
Description
semi-structured interviews of patients by the psychologist
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie BEYLOT BARRY, MD, PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Dermatologie - Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33433714
Citation
Garrouteigt C, Broc G, Legrand A, Quintard B, Beylot-Barry M. Facilitators of and obstacles to consultation in patients with advanced basal cell carcinoma: a French pilot study. Arch Dermatol Res. 2021 Dec;313(10):829-835. doi: 10.1007/s00403-020-02175-x. Epub 2021 Jan 12.
Results Reference
derived
Learn more about this trial
Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma
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