NCT04124796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

October 10, 2019

Last Update Submit

March 24, 2020

Conditions

Keywords

Carcinoma, Basal Cellpsycho-social factors

Outcome Measures

Primary Outcomes (1)

  • Proportion of "psycho-social factors" that chair the decision-making to consul

    semi-structured interviews of patients by the psychologist

    Day 1

Study Arms (2)

target subjects

EXPERIMENTAL

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

Other: Semi-structured interviews

health care team

ACTIVE COMPARATOR

the health care team managing these patients

Other: Semi-structured interviews

Interventions

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.

health care teamtarget subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Dermatologie - Hôpital Saint André

Bordeaux, 33000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Marie BEYLOT BARRY, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: * 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 11, 2019

Study Start

November 12, 2018

Primary Completion

November 12, 2019

Study Completion

November 12, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations