Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Cancer Screening Education Study (SCSES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352428
Recruitment Status : Unknown
Verified May 2019 by Association of Dermatological Prevention, Germany.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2015
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
University of Calgary
University of Alberta
Information provided by (Responsible Party):
Association of Dermatological Prevention, Germany

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Skin Tumors Melanoma Basal Cell Carcinoma Squamous Cell Carcinoma Other: Skin Cancer Screening Training Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Skin Cancer Screening Education Study
Study Start Date : February 2015
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Skin Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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.

  3. Patient-rated well-being [ Time Frame: 20 months ]
    A patient questionnaire will be used to assess psycho-social harms of skin cancer screenings.

  4. Trends of overall skin cancer incidence and stage-specific-incidence [ Time Frame: Up to 6 years (2012-2018) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352428


Locations
Layout table for location information
Canada, Alberta
University of Calgary, University of Alberta
Calgary, Edmonton, Alberta, Canada
Sponsors and Collaborators
Association of Dermatological Prevention, Germany
University of Calgary
University of Alberta
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Association of Dermatological Prevention, Germany
ClinicalTrials.gov Identifier: NCT02352428    
Other Study ID Numbers: LEO-SCSES_1013
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by Association of Dermatological Prevention, Germany:
Skin Cancer
Secondary Prevention
Population Screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases