- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673917
Cosmetology Students and Skin Cancer
September 18, 2018 updated by: Lori Fischbach, University of Arkansas
Assess the efficacy of training cosmetology students to detect suspicious skin lesions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The incidence of melanoma is increasing the USA.
The early detection of skin cancer is associated with a significant decrease in morbidity and mortality.
Hair professionals (cosmetologists and barbers) have an excellent opportunity to detect suspicious skin lesions on the scalp, neck, and face due to routinely looking at this area during customer visits.
Currently in Arkansas, cosmetology schools teach students about how to recognize skin cancer on their clients.
In this program, the aim was to improve the educational module for skin cancer in schools of cosmetology in Arkansas.
In the proposed study, the intervention training module was designed to increase the knowledge of cosmetology schools students about skin cancer will be evaluated.
It was hypothesized that this educational video will educate cosmetology students and cosmetologists about how to prevent skin cancer, how to recognize a suspicious spot or mole which may be a skin cancer, and how to talk with clients about seeing a dermatologist when a suspicious spot is found.
This study was a cluster-randomized controlled trial in cosmetology schools in Arkansas.
The institutional review board for human subjects at the University of Arkansas for Medical Sciences determined that this study was approved as exempt and submission was not required since it was an educational intervention to improve the quality of an educational component of the existing curriculum.
Study Type
Interventional
Enrollment (Actual)
310
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
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The school had not recently or was not currently implementing a similar program.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational video
The educational video on skin cancer for cosmetologists
|
The educational video on skin cancer for cosmetologists
|
Active Comparator: Control video
A publicly accessible healthy lifestyle video on YouTube, which did not contain any information on skin cancer
|
A publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Students' knowledge
Time Frame: 3 - 6 months
|
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
Time Frame: 3 - 6 months
|
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
Time Frame: 3 - 6 months
|
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
Time Frame: 3 - 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lori A Fischbach (co-Principal Investigator), PhD, University of Arkansas
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 (Actual)
September 15, 2016
Primary Completion (Actual)
June 30, 2017
Study Completion (Actual)
September 15, 2017
Study Registration Dates
First Submitted
September 13, 2018
First Submitted That Met QC Criteria
September 13, 2018
First Posted (Actual)
September 17, 2018
Study Record Updates
Last Update Posted (Actual)
September 20, 2018
Last Update Submitted That Met QC Criteria
September 18, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 205582
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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