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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02352428
Other study ID # LEO-SCSES_1013
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date September 2019

Study information

Verified date May 2019
Source Association of Dermatological Prevention, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 113
Est. completion date September 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. 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

2. Physicians

- Registered dermatologists and family physicians administering care either in Edmonton or in Calgary

- English-speaking

- Physicians who consent to participate

Exclusion Criteria:

Physicians who have undergone special training in skin cancer screening within the last 2 years

Study Design


Intervention

Other:
Skin Cancer Screening Training
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.

Locations

Country Name City State
Canada University of Calgary, University of Alberta Calgary, Edmonton Alberta

Sponsors (3)

Lead Sponsor Collaborator
Association of Dermatological Prevention, Germany University of Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 month 1 pre-training (intervention and control region), month 1 post-training (intervention region only), and month 12 (both regions)
Primary 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. 20 months
Primary Patient-rated well-being A patient questionnaire will be used to assess psycho-social harms of skin cancer screenings. 20 months
Primary Trends of overall skin cancer incidence and stage-specific-incidence Up to 6 years (2012-2018)
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