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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Educational video
The educational video on skin cancer for cosmetologists
Other: Educational video
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
Other: Control video
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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