NCT03673917

Brief Summary

Assess the efficacy of training cosmetology students to detect suspicious skin lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

September 13, 2018

Last Update Submit

September 18, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Students' knowledge

    Scale name: Change in students' scores for knowledge of skin cancer, risk factors, and recognizing an abnormal skin spot. What scale measures: Scores were computed as the proportion of questions that the student correctly answered, and change in scores was computed by subtracting the pre-test score from the post-test score. If a student correctly answered a greater proportion of questions on the post-test compared to the pre-test, then they would have a positive value for the change in scores, and would be classified as increasing their knowledge. Scale ranges: The change in scores range from -100% to 100%; a change \>0% is considered to be an increase in score and a better outcome, whereas change \<0% is considered to be a decrease or a worse outcome. Subscales: The 3 subscales are: 1) knowledge of skin cancer, 2) risk factors, and 3) recognition of abnormal spots. The total number of correct answers are summed and divided by the total number of questions to calculate the total score.

    3 - 6 months

  • Perceived importance, interest in, and confidence in looking for abnormal spots

    Name of scale: Change in students' perceived importance, interest in, and confidence in looking for abnormal skin spots. What scale measures: Students selected from the following for perceived importance, interest in, and confidence in looking for abnormal skin spots: i)not at all; ii)slightly/a little bit; iii)somewhat; iv)definitely; or v) very/extremely important/interested in/confidence in (where i represents the lowest level and v represents the highest level). Self-reported post-tests were compared to pre-tests. If the amount of the self-reported importance, interest in or confidence was higher on the post-test compared to the pre-test, then it is considered an increase and a better outcome. Scale ranges: The change for perceived importance, interest in, and confidence in looking for abnormal skin spots were classified only as an increase (better outcome) or not (worse outcome).

    3 - 6 months

  • Skin cancer risk behaviors

    Name of scale: Change in indoor tanning, outdoor tanning, sunscreen and hat use. What scale measures: Students were asked to select from the following frequencies for tanning: 3-7 times per week, 1-2 times per week, 3-7 times in the last 2 months, 1-2 times in the last 2 months, none in the last 2 months. Students selected from the following for hat/sunscreen use: everyday, 1-6 times per week, 1-3 times per month, \<1 time per month, or never. If the frequency of tanning was lower on the post-test compared to the pre-test, then it was classified as a decrease (which is a better outcome). If the frequency of sunscreen use/hat use was higher on the post-test compared to the pre-test, then it was classified as an increase (which is a better outcome). Scale range: The change for sunscreen/hat use was classified only as increasing (the better outcome) or not (the worse outcome); the change in tanning use was classified only as decreasing (the better outcome) or not (the worse outcome).

    3 - 6 months

  • Communication with clients

    Outcomes: Change in looking for abnormal skin spots, talking with clients about skin cancer prevention, and recommending a client see a doctor when an abnormal spot is seen. Students selected from the following proportion of clients in the last month they looked at for abnormal spots: none, \<25%, 25-50%, 51-75%, or \>75%; if the frequency for looking for abnormal spots reported on the post-test was greater than on the pre-test, then there was an increase (better outcome). Students also reported whether they discussed skin cancer prevention as either 'yes' or 'no', and whether or not they had ever recommended that a client see a doctor for an abnormal skin spot. Other outcomes were whether or not students reported on the post-test they looked for abnormal spots on \>50% and \>75% of their clients. Talking with clients about skin cancer prevention, and recommending a client see a doctor was increased (a better outcome) if they responded 'no' on the pre-test and 'yes' on the post-test.

    3 - 6 months

Study Arms (2)

Educational video

EXPERIMENTAL

The educational video on skin cancer for cosmetologists

Other: Educational video

Control video

ACTIVE COMPARATOR

A publicly accessible healthy lifestyle video on YouTube, which did not contain any information on skin cancer

Other: Control video

Interventions

The educational video on skin cancer for cosmetologists

Educational video

A publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer

Control video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Schools: the school director agrees to participate and provide written consent
  • For Students: Students were eligible at the enrolled schools if they agreed in writing to participate, filled out the baseline questionnaire, and viewed the assigned video.

You may not qualify if:

  • The school had not recently or was not currently implementing a similar program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lori A Fischbach (co-Principal Investigator), PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study design protocol is as follows: Schools of cosmetology in Arkansas are randomized using simple randomization to receive either 1) our educational video on skin cancer for cosmetologists or 2) a publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer. Students view the video that was randomly assigned to the school they attended. Pre-video tests are administered at the school during classes or online at the students' convenience; the video intervention follows immediately, also during classes or online. Post-video test (in class or online) are administered 3 to 6 months after watching the video. All schools continued to also use their previous educational materials on skin cancer concurrent with our program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Epidemiology

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 17, 2018

Study Start

September 15, 2016

Primary Completion

June 30, 2017

Study Completion

September 15, 2017

Last Updated

September 20, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations