Skin CanceriSTARTNCT01508013
An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
A study testing Appearance-Focused Website Intervention in people with Skin Cancer, run by East Tennessee State University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a skin cancer prevention website is effective at reduce female teenagers' desire to use indoor tanning and ultimately their use of indoor tanning over an 18 month period. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Appearance-Focused Website Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Teenager between 12 and 18 years old; has either indoor tanned in the past year or has indicated their intentions to indoor tan in the coming year.
Who cannot join
- None other than not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
The purpose of this study is to determine whether a skin cancer prevention website is effective at reduce female teenagers' desire to use indoor tanning and ultimately their use of indoor tanning over an 18 month period.
Read the detailed description
The project is designed to improve the understanding of, and ability to affect UV risk behavior in teenage populations. The International Agency for Research in Cancer classifies indoor tanning as "carcinogenic to humans." There is evidence that female indoor tanning use increases dramatically from freshman to senior years of high school (e.g., 25-40% of older high school girls) making high school a critical time period for anti-tanning interventions to be carried out. This proposal assesses the effectiveness of a skin cancer prevention website for a nationally representative sample of high school teens in a randomized controlled trial. Teens exposed to the website will report reduced indoor tanning intentions, frequency and overall percentage of users while increasing sun protective behaviors at long-term (i.e 18 month) follow-up.
- Conditions
- Skin Cancer
- Being tested
- Appearance-Focused Website Intervention, Control Website
- Keywords
- Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Medical subject headings
- Skin Neoplasms, Melanoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appearance-Focused Website InterventionBehavioural
The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
Control WebsiteBehavioural
The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
| Study group | Role | What they receive |
|---|---|---|
| Appearance-Focused Website Intervention | Experimental | This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Receives: Behavioral: Appearance-Focused Website Intervention |
| Control Website | Active comparator | Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Receives: Behavioral: Control Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indoor Tanning Behavior
Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.
Measured: 12 months
Indoor Tanning Intentions
A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).
Measured: 12 months
Indoor Tanning Willingness
Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Hillhouse, East Tennessee State University
- Investigators
- Joel J Hillhouse, Ph.D., Principal investigator, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508013
- Sponsor's protocol ID
- 1R01CA134891-01A2
- Acronym
- iSTART
- Status last verified
- Apr 2016
- First submitted
- 9 Jan 2012
- Last updated
- 2 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The proposed research will include data from high school teenage women who indoor tan. The final dataset will include self-reported demographic, attitudinal, cognitive and behavioral data from surveys about private personal behaviors. The final dataset will be stripped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and to not attempting to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
- ClinicalTrials.gov ID
- NCT01508013
- Acronym / sponsor ID
- iSTART / 1R01CA134891-01A2
- Conditions
- Skin Cancer
- Keywords
- Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Posted 2 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a skin cancer prevention website is effective at reduce female teenagers' desire to use indoor tanning and ultimately their use of indoor tanning over an 18 month period.
Detailed description
The project is designed to improve the understanding of, and ability to affect UV risk behavior in teenage populations. The International Agency for Research in Cancer classifies indoor tanning as "carcinogenic to humans." There is evidence that female indoor tanning use increases dramatically from freshman to senior years of high school (e.g., 25-40% of older high school girls) making high school a critical time period for anti-tanning interventions to be carried out. This proposal assesses the effectiveness of a skin cancer prevention website for a nationally representative sample of high school teens in a randomized controlled trial. Teens exposed to the website will report reduced indoor tanning intentions, frequency and overall percentage of users while increasing sun protective behaviors at long-term (i.e 18 month) follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appearance-Focused Website Intervention | Experimental | Behavioral: Appearance-Focused Website InterventionThis is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. |
| Control Website | Active comparator | Behavioral: Control WebsiteControl participants viewed an Internet site designed to provide drug and alcohol education for teens. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Teenager between 12 and 18 years old; has either indoor tanned in the past year or has indicated their intentions to indoor tan in the coming year.
Key exclusion criteria (1 listed)
- None other than not meeting inclusion criteria.
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 |
|---|---|---|
| Appearance-Focused Website InterventionThe intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning. | Behavioural | Appearance-Focused Website Intervention |
| Control WebsiteThe control website contains information about alcohol and drug abuse which is oriented for a teen audience. | Behavioural | Control Website |
Primary outcome
Indoor Tanning Behavior
Time frame: 12 months
Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.
Indoor Tanning Intentions
Time frame: 12 months
A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).
Indoor Tanning Willingness
Time frame: 12 months
Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The proposed research will include data from high school teenage women who indoor tan. The final dataset will include self-reported demographic, attitudinal, cognitive and behavioral data from surveys about private personal behaviors. The final dataset will be stripped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and to not attempting to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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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.
Joel J Hillhouse, Ph.D. principal investigator
East Tennessee State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appearance-Focused Website Intervention in people with Skin Cancer, run by East Tennessee State University 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 1 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 2 Jun 2016. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Indoor Tanning Behavior (time frame: 12 months). The study lists 3 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 2 Jun 2016.