Skin TumorsSCSESNCT02352428
Skin Cancer Screening Education Study
A study testing Skin Cancer Screening Training in people with Skin Tumors and Melanoma, run by Association of Dermatological Prevention, Germany at 1 site in Canada.
Trial summary
The overall aim of this population-based screening study is to assess whether the skin cancer screening training of family physicians and dermatologists leads to improved screening outcomes. The training course aims to increase the accuracy of detecting early stages of skin cancer. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Tumors, Melanoma, Basal Cell Carcinoma
- What is being tested?
- Skin Cancer Screening Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Sep 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screenees
- Male and female residents of Alberta mainly living and receiving care in Edmonton or in Calgary
- Age 20+
- English-speaking
- Individuals who consent to participate
- Physicians
Show all 9Show fewer
- Registered dermatologists and family physicians administering care either in Edmonton or in Calgary
- English-speaking
- Physicians who consent to participate
Who cannot join
- Physicians who have undergone special training in skin cancer screening within the last 2 years
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary, University of Alberta
Calgary, Edmonton, Alberta
About this study
The overall aim of this population-based screening study is to assess whether the skin cancer screening training of family physicians and dermatologists leads to improved screening outcomes. The training course aims to increase the accuracy of detecting early stages of skin cancer. Screening outcomes of an intervention region (Calgary, Canada) in which physicians receive training will be compared with screening outcomes of a control region (Edmonton, Canada) where no physician training is administered.
The investigators will determine whether:
Read more
- clinical screening outcomes are more favorable in the group of trained physicians compared to non trained physicians
- there is an increase of knowledge about skin cancer screening among trained physicians, compared to non trained physicians
- skin cancer screenings are associated with psycho-social harms
- population-based screening has an effect on the overall incidence and stage-specific-incidence of skin cancer in Alberta
The investigators are aiming to recruit 100 physicians per region (total of 200 physicians) who will screen 40,000 to 80,000 individuals over a period of 20 months.
- Conditions
- Skin Tumors, Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Being tested
- Skin Cancer Screening Training
- Keywords
- Skin Cancer, Secondary Prevention, Population Screening
- Medical subject headings
- Skin Neoplasms, Melanoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Cancer Screening TrainingOther
Topics of the 5.5-hour in-class course include: the screening test, types of skin cancer (signs and symptoms), case history taking, epidemiology of skin cancer, etiology, risk factors and risk groups, communicative aspects of primary and secondary preventive measures, and benefits and harms of cancer screenings.
| Study group | Role | What they receive |
|---|---|---|
| Skin Cancer Screening Training | Experimental | Recruited family physicians and dermatologists in Calgary, Canada, take part in a 5.5-hour face-to-face skin cancer screening training program. Screening for skin cancer will be conducted by trained physicians according to instructions they received in the training program. Receives: Other: Skin Cancer Screening Training |
| No Skin Cancer Screening Training | No intervention | Recruited family physicians and dermatologists in Edmonton, Canada, WILL BE TRAINED AFTER THE SCREENING PHASE, i.e. during the screening phase non-trained physicians will carry out skin cancer screenings according to standard medical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the diagnostic accuracy including knowledge on skin cancer screening
Educational outcomes of physicians will be measured pre- and post-training using knowledge tests in the intervention and control region
Measured: month 1 pre-training (intervention and control region), month 1 post-training (intervention region only), and month 12 (both regions)
Number needed to screen (NNS) to identify 1 skin tumor and number needed to excise (NNE) to identify 1 skin tumor
Case report forms will be analyzed to determine clinical screening outcomes such as the NNS, NNE and tumor thickness.
Measured: 20 months
Patient-rated well-being
A patient questionnaire will be used to assess psycho-social harms of skin cancer screenings.
Measured: 20 months
Trends of overall skin cancer incidence and stage-specific-incidence
Measured: Up to 6 years (2012-2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2018
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TumorsStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dermatological Prevention, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Lynne H Robertson, MD, FRCPC, Principal investigator, University of CalgaryGordon E Searles, MD, FRCPC, Principal investigator, University of AlbertaEckhard W Breitbart, MD, PhD, Principal investigator, Association of Dermatological Prevention, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352428
- Sponsor's protocol ID
- LEO-SCSES_1013
- Acronym
- SCSES
- Status last verified
- May 2019
- First submitted
- 13 Jan 2015
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Cancer Screening Education Study
- ClinicalTrials.gov ID
- NCT02352428
- Acronym / sponsor ID
- SCSES / LEO-SCSES_1013
- Conditions
- Skin Tumors, Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Keywords
- Skin Cancer, Secondary Prevention, Population Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Association of Dermatological Prevention, GermanyUniversity, hospital or other
- Collaborators
- University of Calgary, University of Alberta
- Study start
- Feb 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- 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 overall aim of this population-based screening study is to assess whether the skin cancer screening training of family physicians and dermatologists leads to improved screening outcomes. The training course aims to increase the accuracy of detecting early stages of skin cancer. Screening outcomes of an intervention region (Calgary, Canada) in which physicians receive training will be compared with screening outcomes of a control region (Edmonton, Canada) where no physician training is administered.
The investigators will determine whether:
- clinical screening outcomes are more favorable in the group of trained physicians compared to non trained physicians
- there is an increase of knowledge about skin cancer screening among trained physicians, compared to non trained physicians
- skin cancer screenings are associated with psycho-social harms
- population-based screening has an effect on the overall incidence and stage-specific-incidence of skin cancer in Alberta
The investigators are aiming to recruit 100 physicians per region (total of 200 physicians) who will screen 40,000 to 80,000 individuals over a period of 20 months.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Cancer Screening Training | Experimental | Other: Skin Cancer Screening TrainingRecruited family physicians and dermatologists in Calgary, Canada, take part in a 5.5-hour face-to-face skin cancer screening training program. Screening for skin cancer will be conducted by trained physicians according to instructions they received in the training program. |
| No Skin Cancer Screening Training | No intervention | –Recruited family physicians and dermatologists in Edmonton, Canada, WILL BE TRAINED AFTER THE SCREENING PHASE, i.e. during the screening phase non-trained physicians will carry out skin cancer screenings according to standard medical practice. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Screenees
- Physicians
Key exclusion criteria (1 listed)
- Physicians who have undergone special training in skin cancer screening within the last 2 years
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 |
|---|---|---|
| Skin Cancer Screening TrainingTopics of the 5.5-hour in-class course include: the screening test, types of skin cancer (signs and symptoms), case history taking, epidemiology of skin cancer, etiology, risk factors and risk groups, communicative aspects of primary and secondary preventive measures, and benefits and harms of cancer screenings. | Other | Skin Cancer Screening Training |
Primary outcome
Change in the diagnostic accuracy including knowledge on skin cancer screening
Time frame: month 1 pre-training (intervention and control region), month 1 post-training (intervention region only), and month 12 (both regions)
Educational outcomes of physicians will be measured pre- and post-training using knowledge tests in the intervention and control region
Number needed to screen (NNS) to identify 1 skin tumor and number needed to excise (NNE) to identify 1 skin tumor
Time frame: 20 months
Case report forms will be analyzed to determine clinical screening outcomes such as the NNS, NNE and tumor thickness.
Patient-rated well-being
Time frame: 20 months
A patient questionnaire will be used to assess psycho-social harms of skin cancer screenings.
Trends of overall skin cancer incidence and stage-specific-incidence
Time frame: Up to 6 years (2012-2018)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Study websiteLink provided by the sponsor.
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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.
Lynne H Robertson, MD, FRCPC principal investigator
University of Calgary
Gordon E Searles, MD, FRCPC principal investigator
University of Alberta
Eckhard W Breitbart, MD, PhD principal investigator
Association of Dermatological Prevention, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Cancer Screening Training in people with Skin Tumors and Melanoma, run by Association of Dermatological Prevention, Germany at 1 site in Canada.
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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 2019. 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 Canada. 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?
Results are not available in the source record.
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?
Change in the diagnostic accuracy including knowledge on skin cancer screening (time frame: month 1 pre-training (intervention and control region), month 1 post-training (intervention region only), and month 12 (both regions)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2019.