NCT02352428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

3.8 years

First QC Date

January 13, 2015

Last Update Submit

May 2, 2019

Conditions

Keywords

Skin CancerSecondary PreventionPopulation Screening

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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

  • Patient-rated well-being

    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

    Up to 6 years (2012-2018)

Study Arms (2)

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.

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.

Interventions

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.

Skin Cancer Screening Training

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary, University of Alberta

Calgary, Edmonton, Alberta, Canada

Location

Related Links

MeSH Terms

Conditions

Skin NeoplasmsMelanomaCarcinoma, Basal CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal CellNeoplasms, Squamous Cell

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 2, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

September 1, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations