Skin Cancer Screening Education Study (SCSES)

May 2, 2019 updated by: Association of Dermatological Prevention, Germany

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Edmonton, Alberta, Canada
        • University of Calgary, University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin Cancer Screening Training
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.
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.
No Intervention: No Skin Cancer Screening Training
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 20 months
Case report forms will be analyzed to determine clinical screening outcomes such as the NNS, NNE and tumor thickness.
20 months
Patient-rated well-being
Time Frame: 20 months
A patient questionnaire will be used to assess psycho-social harms of skin cancer screenings.
20 months
Trends of overall skin cancer incidence and stage-specific-incidence
Time Frame: Up to 6 years (2012-2018)
Up to 6 years (2012-2018)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Dermatological Prevention, Germany

Collaborators

University of Alberta
University of Calgary

Investigators

  • Principal Investigator: Lynne H Robertson, MD, FRCPC, University of Calgary
  • Principal Investigator: Gordon E Searles, MD, FRCPC, University of Alberta
  • Principal Investigator: Eckhard W Breitbart, MD, PhD, Association of Dermatological Prevention, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEO-SCSES_1013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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