Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma (PSYCHO-CBC)
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bordeaux, France, 33000
- Service de Dermatologie - Hôpital Saint André
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: target subjects
"target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit.
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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.
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Active Comparator: health care team
the health care team managing these patients
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of "psycho-social factors" that chair the decision-making to consul
Time Frame: Day 1
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semi-structured interviews of patients by the psychologist
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Day 1
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie BEYLOT BARRY, MD, PhD, University Hospital, Bordeaux
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2018/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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