Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma (PSYCHO-CBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124796
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Bordeaux Population Health Research centre
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell, Malignant Other: Semi-structured interviews Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : November 12, 2019
Estimated Study Completion Date : November 12, 2019

Arm Intervention/treatment
Experimental: target subjects
"target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit.
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.

Active Comparator: health care team
the health care team managing these patients
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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124796


Contacts
Layout table for location contacts
Contact: Marie BEYLOT BARRY, MD, PhD +335 57 82 25 00 marie.beylot-barry@chu-bordeaux.fr
Contact: Bruno QUINTARD, PhD +335 57 57 13 93 Bruno.Quintard@u-bordeaux.fr

Locations
Layout table for location information
France
Service de Dermatologie - Hôpital Saint André Recruiting
Bordeaux, France, 33000
Contact: Marie BEYLOT-BARRY, MD, PhD    +(33) 5 57 65 64 32    marie.beylot-barry@chu-bordeaux.fr   
Principal Investigator: Marie BEYLOT-BARRY, MD,PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Bordeaux Population Health Research centre
Investigators
Layout table for investigator information
Principal Investigator: Marie BEYLOT BARRY, MD, PhD University Hospital, Bordeaux

Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04124796     History of Changes
Other Study ID Numbers: CHUBX 2018/16
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Carcinoma, Basal Cell
psycho-social factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell