Carcinoma, Basal Cell, MalignantPSYCHO-CBCNCT04124796
Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma
A study testing Semi-structured interviews in people with Carcinoma, Basal Cell, Malignant, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Basal Cell, Malignant
- What is being tested?
- Semi-structured interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2018to 12 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Carcinoma, Basal Cell, Malignant
- Being tested
- Semi-structured interviews
- Keywords
- Carcinoma, Basal Cell, psycho-social factors
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| target subjects | Experimental | "target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit. Receives: Other: Semi-structured interviews |
| health care team | Active comparator | the health care team managing these patients Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of "psycho-social factors" that chair the decision-making to consul
semi-structured interviews of patients by the psychologist
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start12 Nov 2018
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Basal Cell, MalignantStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Bordeaux Population Health Research centre
- Responsible party
- Sponsor
- Investigators
- Marie BEYLOT BARRY, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124796
- Sponsor's protocol ID
- CHUBX 2018/16
- Acronym
- PSYCHO-CBC
- Status last verified
- Mar 2020
- First submitted
- 10 Oct 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33433714
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04124796
- Acronym / sponsor ID
- PSYCHO-CBC / CHUBX 2018/16
- Conditions
- Carcinoma, Basal Cell, Malignant
- Keywords
- Carcinoma, Basal Cell, psycho-social factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Bordeaux Population Health Research centre
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| target subjects | Experimental | Other: Semi-structured interviews"target subjects" patients are expected, corresponding to the average population received each year for a CBCa in the unit. |
| health care team | Active comparator | Other: Semi-structured interviewsthe health care team managing these patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsBased 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. | Other | health care team, target subjects |
Primary outcome
Proportion of "psycho-social factors" that chair the decision-making to consul
Time frame: Day 1
semi-structured interviews of patients by the psychologist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 33433714Garrouteigt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie BEYLOT BARRY, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interviews in people with Carcinoma, Basal Cell, Malignant, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of "psycho-social factors" that chair the decision-making to consul (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.