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Trial record 13 of 537 for:    "Skin cancer"

An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk (iSTART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01508013
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : June 2, 2016
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Joel Hillhouse, East Tennessee State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Skin Cancer
Interventions Behavioral: Appearance-Focused Website Intervention
Behavioral: Control Website
Enrollment 443
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Appearance-Focused Website Intervention Control Website
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 214 229
Completed 182 206
Not Completed 32 23
Arm/Group Title Appearance-Focused Website Intervention Control Website Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 214 229 443
Hide Baseline Analysis Population Description
Adolescent females aged 12-18 years old who expressed interest in future indoor tanning.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants 229 participants 443 participants
15.19  (1.89) 15.24  (1.91) 15.21  (1.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 229 participants 443 participants
Female
214
 100.0%
229
 100.0%
443
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 229 participants 443 participants
Hispanic or Latino
26
  12.1%
28
  12.2%
54
  12.2%
Not Hispanic or Latino
188
  87.9%
201
  87.8%
389
  87.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 214 participants 229 participants 443 participants
214 229 443
Indoor Tanning Frequency  
Mean (Standard Deviation)
Unit of measure:  Indoor tanning sessions
Number Analyzed 214 participants 229 participants 443 participants
6.36  (25.29) 5.94  (23.01) 6.14  (24.11)
Indoor Tanning Intentions Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 214 participants 229 participants 443 participants
4.14  (2.00) 3.74  (2.01) 3.93  (2.01)
[1]
Measure Description: The Indoor Tanning Intentions Scale can range from 1 (definitely do not intend; better) to 7 (definitely do intend; worse).
Indoor Tanning Willingness Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 214 participants 229 participants 443 participants
4.66  (1.92) 4.55  (1.85) 4.60  (1.88)
[1]
Measure Description: The Indoor Tanning Willingness scale ranges from 1 (definitely not willing; better ) to 7 (definitely willing; worse).
Indoor Tanning Attitudes Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 214 participants 229 participants 443 participants
9.67  (3.35) 9.34  (3.35) 9.50  (3.35)
[1]
Measure Description: The Indoor Tanning Attitudes Scale can range from 3 (strongly negative attitudes toward indoor tanning; better) to 15 (strongly positive attitudes toward indoor tanning; worse)
Indoor Tanning Social Approval Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 214 participants 229 participants 443 participants
11.99  (2.54) 11.23  (2.87) 11.59  (2.74)
[1]
Measure Description: The Indoor Tanning Social Approval Scale can range from 3 (strong beliefs peers do not approve indoor tanning; better) to 15 (strong beliefs peers do approve indoor tanning; worse)
Indoor Tanning Skin Damage Susceptibility Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 214 participants 229 participants 443 participants
18.79  (4.81) 19.20  (4.61) 19.00  (4.71)
[1]
Measure Description: The Indoor Tanning Skin Damage Susceptibility scale can range from 5 (low perceived susceptibility to skin damage from indoor tanning; worse) to 25 (high perceived susceptibility to skin damage from indoor tanning; better).
1.Primary Outcome
Title Indoor Tanning Behavior
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the future.
Arm/Group Title Appearance-Focused Website Intervention Control Website
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 182 206
Mean (Standard Deviation)
Unit of Measure: Indoor tanning sessions over past year
5.29  (14.89) 6.30  (16.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Appearance-Focused Website Intervention, Control Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .633
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Indoor Tanning Intentions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the next year.
Arm/Group Title Appearance-Focused Website Intervention Control Website
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 182 206
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.91  (1.96) 3.28  (2.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Appearance-Focused Website Intervention, Control Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Indoor Tanning Willingness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adolescent females aged 12-18 years old that expressed interest in indoor tanning in the future.
Arm/Group Title Appearance-Focused Website Intervention Control Website
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 182 206
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.34  (2.16) 3.73  (62.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Appearance-Focused Website Intervention, Control Website
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .018
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Appearance-Focused Website Intervention Control Website
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Appearance-Focused Website Intervention Control Website
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Appearance-Focused Website Intervention Control Website
Affected / at Risk (%) Affected / at Risk (%)
Total   0/182 (0.00%)   0/206 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Appearance-Focused Website Intervention Control Website
Affected / at Risk (%) Affected / at Risk (%)
Total   0/182 (0.00%)   0/206 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Joel Hillhouse
Organization: East Tennessee State University
Phone: 423-439-4332
Responsible Party: Joel Hillhouse, East Tennessee State University
ClinicalTrials.gov Identifier: NCT01508013     History of Changes
Other Study ID Numbers: 1R01CA134891-01A2 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2012
First Posted: January 11, 2012
Results First Submitted: January 21, 2016
Results First Posted: June 2, 2016
Last Update Posted: June 2, 2016