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An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk

An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01508013
Acronym
iSTART
Enrollment
443
Registered
2012-01-11
Start date
2011-05-31
Completion date
2014-12-31
Last updated
2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer

Keywords

Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma

Brief 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.

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.

Interventions

BEHAVIORALAppearance-Focused Website Intervention

The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.

BEHAVIORALControl Website

The control website contains information about alcohol and drug abuse which is oriented for a teen audience.

Sponsors

East Tennessee State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* None other than not meeting inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Indoor Tanning Behavior12 monthsSelf-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 Intentions12 monthsA 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 Willingness12 monthsScale 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Appearance-Focused Website Intervention
This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
214
Control Website
Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
229
Total443

Baseline characteristics

CharacteristicTotalControl WebsiteAppearance-Focused Website Intervention
Age, Continuous15.21 years
STANDARD_DEVIATION 1.89
15.24 years
STANDARD_DEVIATION 1.91
15.19 years
STANDARD_DEVIATION 1.89
Ethnicity (NIH/OMB)
Hispanic or Latino
54 Participants28 Participants26 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
389 Participants201 Participants188 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Indoor Tanning Attitudes Scale9.50 units on a scale
STANDARD_DEVIATION 3.35
9.34 units on a scale
STANDARD_DEVIATION 3.35
9.67 units on a scale
STANDARD_DEVIATION 3.35
Indoor Tanning Frequency6.14 Indoor tanning sessions
STANDARD_DEVIATION 24.11
5.94 Indoor tanning sessions
STANDARD_DEVIATION 23.01
6.36 Indoor tanning sessions
STANDARD_DEVIATION 25.29
Indoor Tanning Intentions Scale3.93 units on a scale
STANDARD_DEVIATION 2.01
3.74 units on a scale
STANDARD_DEVIATION 2.01
4.14 units on a scale
STANDARD_DEVIATION 2
Indoor Tanning Skin Damage Susceptibility Scale19.00 units on a scale
STANDARD_DEVIATION 4.71
19.20 units on a scale
STANDARD_DEVIATION 4.61
18.79 units on a scale
STANDARD_DEVIATION 4.81
Indoor Tanning Social Approval Scale11.59 units on a scale
STANDARD_DEVIATION 2.74
11.23 units on a scale
STANDARD_DEVIATION 2.87
11.99 units on a scale
STANDARD_DEVIATION 2.54
Indoor Tanning Willingness Scale4.60 units on a scale
STANDARD_DEVIATION 1.88
4.55 units on a scale
STANDARD_DEVIATION 1.85
4.66 units on a scale
STANDARD_DEVIATION 1.92
Region of Enrollment
United States
443 participants229 participants214 participants
Sex: Female, Male
Female
443 Participants229 Participants214 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1820 / 206
serious
Total, serious adverse events
0 / 1820 / 206

Outcome results

Primary

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.

Time frame: 12 months

Population: Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the future.

ArmMeasureValue (MEAN)Dispersion
Appearance-Focused Website InterventionIndoor Tanning Behavior5.29 Indoor tanning sessions over past yearStandard Deviation 14.89
Control WebsiteIndoor Tanning Behavior6.30 Indoor tanning sessions over past yearStandard Deviation 16.08
p-value: 0.633Mixed Models Analysis
Primary

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).

Time frame: 12 months

Population: Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the next year.

ArmMeasureValue (MEAN)Dispersion
Appearance-Focused Website InterventionIndoor Tanning Intentions2.91 units on a scaleStandard Deviation 1.96
Control WebsiteIndoor Tanning Intentions3.28 units on a scaleStandard Deviation 2.1
p-value: 0.001Mixed Models Analysis
Primary

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).

Time frame: 12 months

Population: Adolescent females aged 12-18 years old that expressed interest in indoor tanning in the future.

ArmMeasureValue (MEAN)Dispersion
Appearance-Focused Website InterventionIndoor Tanning Willingness3.34 units on a scaleStandard Deviation 2.16
Control WebsiteIndoor Tanning Willingness3.73 units on a scaleStandard Deviation 62.22
p-value: 0.018Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026