A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults (UV4me)
Primary Purpose
Skin Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UV4me
Skin Cancer Foundation website
Sponsored by
About this trial
This is an interventional prevention trial for Skin Neoplasms focused on measuring prevention or control
Eligibility Criteria
Inclusion Criteria:
- Age 18-25 years old
- Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)
Exclusion Criteria:
- History of skin cancer
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Tailored Intervention
Skin Cancer Foundation Website
Assessment Only Condition
Arm Description
Subject has access to the tailored web intervention
Subject has access to the pre-existing Skin Cancer Foundation website
Subjects will only complete assessments
Outcomes
Primary Outcome Measures
Sun protection
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Sun protection
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Outdoor UV Exposure
How many hours participants spend in the sun during peak daylight hours during the week
Outdoor UV exposure
How many hours participants spend in the sun during peak daylight hours during the week
Secondary Outcome Measures
Indoor Tanning
Number of indoor tanning sessions in past month
Indoor Tanning
Number of indoor tanning sessions in past month
Full Information
NCT ID
NCT02147080
First Posted
May 22, 2014
Last Updated
June 29, 2018
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02147080
Brief Title
A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults
Acronym
UV4me
Official Title
A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Skin cancer is the most common cancer in the US, with over a million new cases diagnosed yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all age groups and also demonstrate increased exposure to natural and artificial UV radiation. Innovative interventions are needed to have an impact on skin cancer risk among young people. Unlike previous interventions, our skin cancer risk reduction intervention will be tailored (or personalized) to each individual participant and delivered via the Internet. The intervention will emphasize appearance concerns, which are known to be the primary motivation for UV exposure and lack of skin protection among young adults. This will be accomplished in part through the use of personalized facial images showing UV damage as well as computerized age progression demonstrations.
Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet designed to increase skin protection and decrease sun exposure behavior among young adults at moderate to high risk of developing skin cancer. Participants will be randomized to the tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.
Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family history of skin cancer), appearance consciousness, and past exposure and protective behaviors moderate intervention effects.
Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.
The goals of future research would be to enhance the tailored intervention, for example, by adding additional contacts or Internet technologies or features, disseminate the intervention, assess the longevity of effects, and/or adapt the tailored intervention for use with other cancer risk behaviors or at risk groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Neoplasms
Keywords
prevention or control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored Intervention
Arm Type
Experimental
Arm Description
Subject has access to the tailored web intervention
Arm Title
Skin Cancer Foundation Website
Arm Type
Active Comparator
Arm Description
Subject has access to the pre-existing Skin Cancer Foundation website
Arm Title
Assessment Only Condition
Arm Type
No Intervention
Arm Description
Subjects will only complete assessments
Intervention Type
Behavioral
Intervention Name(s)
UV4me
Other Intervention Name(s)
Tailored Intervention for Skin Cancer Risk Reduction
Intervention Description
Tailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator
Intervention Type
Behavioral
Intervention Name(s)
Skin Cancer Foundation website
Intervention Description
Current best practice website for skin cancer and prevention. Includes information, images, news, and opportunities for advocacy.
Primary Outcome Measure Information:
Title
Sun protection
Description
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Time Frame
Follow-up 1 (3 weeks after baseline)
Title
Sun protection
Description
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
Time Frame
Follow-up 2 (12 weeks after baseline)
Title
Outdoor UV Exposure
Description
How many hours participants spend in the sun during peak daylight hours during the week
Time Frame
Follow-up 1 (3 weeks after baseline)
Title
Outdoor UV exposure
Description
How many hours participants spend in the sun during peak daylight hours during the week
Time Frame
Follow-up 2 (12 weeks after baseline)
Secondary Outcome Measure Information:
Title
Indoor Tanning
Description
Number of indoor tanning sessions in past month
Time Frame
Follow-up 1 (3 weeks after baseline)
Title
Indoor Tanning
Description
Number of indoor tanning sessions in past month
Time Frame
Follow-up 2 (12 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Spray-on tan
Description
Number of spray-on tanning sessions in past month
Time Frame
Follow-up 1 (3 weeks after baseline)
Title
Spray-on tan
Description
Number of spray-on tanning sessions in past month
Time Frame
Follow-up 2 (12 weeks after baseline)
Title
Sunless tanning creams
Description
Number of times sunless tanning cream has been used in the past month
Time Frame
Follow-up 1 (3 weeks after baseline)
Title
Sunless tanning creams
Description
Number of times sunless tanning cream has been used in the past month
Time Frame
Follow-up 2 (12 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-25 years old
Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)
Exclusion Criteria:
History of skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Heckman, Ph.D
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27819460
Citation
Heckman CJ, Handorf EA, Darlow SD, Ritterband LM, Manne SL. An online skin cancer risk-reduction intervention for young adults: Mechanisms of effects. Health Psychol. 2017 Mar;36(3):215-225. doi: 10.1037/hea0000420. Epub 2016 Nov 7.
Results Reference
derived
PubMed Identifier
26810358
Citation
Heckman CJ, Darlow SD, Ritterband LM, Handorf EA, Manne SL. Efficacy of an Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Am J Prev Med. 2016 Jul;51(1):1-11. doi: 10.1016/j.amepre.2015.11.008. Epub 2016 Jan 22.
Results Reference
derived
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A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults
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