Cosmetology Students and Skin Cancer
Primary Purpose
Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational video
Control video
Sponsored by
About this trial
This is an interventional other trial for Skin Cancer
Eligibility Criteria
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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Educational video
Control video
Arm Description
The educational video on skin cancer for cosmetologists
A publicly accessible healthy lifestyle video on YouTube, which did not contain any information on skin cancer
Outcomes
Primary Outcome Measures
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.
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).
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03673917
First Posted
September 13, 2018
Last Updated
September 18, 2018
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT03673917
Brief Title
Cosmetology Students and Skin Cancer
Official Title
Cosmetology Students and Skin Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 15, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess the efficacy of training cosmetology students to detect suspicious skin lesions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational video
Arm Type
Experimental
Arm Description
The educational video on skin cancer for cosmetologists
Arm Title
Control video
Arm Type
Active Comparator
Arm Description
A publicly accessible healthy lifestyle video on YouTube, which did not contain any information on skin cancer
Intervention Type
Other
Intervention Name(s)
Educational video
Intervention Description
The educational video on skin cancer for cosmetologists
Intervention Type
Other
Intervention Name(s)
Control video
Intervention Description
A publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer
Primary Outcome Measure Information:
Title
Students' knowledge
Description
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.
Time Frame
3 - 6 months
Title
Perceived importance, interest in, and confidence in looking for abnormal spots
Description
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).
Time Frame
3 - 6 months
Title
Skin cancer risk behaviors
Description
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).
Time Frame
3 - 6 months
Title
Communication with clients
Description
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.
Time Frame
3 - 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori A Fischbach (co-Principal Investigator), PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Cosmetology Students and Skin Cancer
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