Skin CancerNCT03673917
Cosmetology Students and Skin Cancer
A study testing Educational video in people with Skin Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
Assess the efficacy of training cosmetology students to detect suspicious skin lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2016to 15 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The school had not recently or was not currently implementing a similar program.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Assess the efficacy of training cosmetology students to detect suspicious skin lesions.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- Educational video, Control video
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
The educational video on skin cancer for cosmetologists
Control videoOther
A publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer
| Study group | Role | What they receive |
|---|---|---|
| Educational video | Experimental | The educational video on skin cancer for cosmetologists Receives: Other: Educational video |
| Control video | Active comparator | A publicly accessible healthy lifestyle video on YouTube, which did not contain any information on skin cancer Receives: Other: Control video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 3 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start15 Sep 2016
- Primary completion30 Jun 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Fischbach, University of Arkansas
- Investigators
- Lori A Fischbach (co-Principal Investigator), PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673917
- Sponsor's protocol ID
- 205582
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetology Students and Skin Cancer
- ClinicalTrials.gov ID
- NCT03673917
- Acronym / sponsor ID
- 205582
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educational video | Experimental | Other: Educational videoThe educational video on skin cancer for cosmetologists |
| Control video | Active comparator | Other: Control videoA publicly accessible healthy lifestyle video on YouTube, which did not contain any information on skin cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The school had not recently or was not currently implementing a similar program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoThe educational video on skin cancer for cosmetologists | Other | Educational video |
| Control videoA publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer | Other | Control video |
Primary outcome
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.
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Skin Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Fischbach (co-Principal Investigator), PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Skin Cancer, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Students' knowledge (time frame: 3 - 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.