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Skin Cancer Screening Education Study (SCSES)

Primary Purpose

Skin Tumors, Melanoma, Basal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Skin Cancer Screening Training
Sponsored by
Association of Dermatological Prevention, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Skin Tumors focused on measuring Skin Cancer, Secondary Prevention, Population Screening

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Calgary, University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Skin Cancer Screening Training

No Skin Cancer Screening Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
Patient-rated well-being
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

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
May 2, 2019
Sponsor
Association of Dermatological Prevention, Germany
Collaborators
University of Calgary, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT02352428
Brief Title
Skin Cancer Screening Education Study
Acronym
SCSES
Official Title
Skin Cancer Screening Education Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association of Dermatological Prevention, Germany
Collaborators
University of Calgary, University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Tumors, Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
Keywords
Skin Cancer, Secondary Prevention, Population Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin Cancer Screening Training
Arm Type
Experimental
Arm Description
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.
Arm Title
No Skin Cancer Screening Training
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Skin Cancer Screening Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the diagnostic accuracy including knowledge on skin cancer screening
Description
Educational outcomes of physicians will be measured pre- and post-training using knowledge tests in the intervention and control region
Time Frame
month 1 pre-training (intervention and control region), month 1 post-training (intervention region only), and month 12 (both regions)
Title
Number needed to screen (NNS) to identify 1 skin tumor and number needed to excise (NNE) to identify 1 skin tumor
Description
Case report forms will be analyzed to determine clinical screening outcomes such as the NNS, NNE and tumor thickness.
Time Frame
20 months
Title
Patient-rated well-being
Description
A patient questionnaire will be used to assess psycho-social harms of skin cancer screenings.
Time Frame
20 months
Title
Trends of overall skin cancer incidence and stage-specific-incidence
Time Frame
Up to 6 years (2012-2018)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne H Robertson, MD, FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon E Searles, MD, FRCPC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eckhard W Breitbart, MD, PhD
Organizational Affiliation
Association of Dermatological Prevention, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary, University of Alberta
City
Calgary, Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.scses-alberta.org
Description
Study website

Learn more about this trial

Skin Cancer Screening Education Study

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