The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | July 1, 2008 | ||||
| Last Updated Date | July 1, 2008 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Melanin skin content (spectrophotometry) [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention | ||||
| Official Title ICMJE | The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention | ||||
| Brief Summary | The purpose of the proposed project is to investigate the efficacy and longevity of two novel approaches to changing skin protection behaviors: 1) UV-detect photos that reveal currently existing skin damage and 2) motivational interviewing (MI), a person-centered, yet directive counseling style used to enhance internal motivation to change health behaviors. The proposed investigations include a pilot study to refine the methodology; a small formal randomized controlled efficacy trial; and a dismantling study. These studies will also expand current knowledge and research in several major ways: 1) the use of UV-detect photos will enable highly salient and personalized feedback, 2) MI will be used in a previously untried health domain (skin cancer prevention), 3) objective skin color changes will be measured using state-of-the-art skin reflectance spectrophotometry, and 4) the proposed studies will test aspects of several major psychological theories (e.g., Transtheoretical Model, Prototype/Willingness Model) to identify moderators/mediators of outcome. |
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| Detailed Description | Teens and young adults are at high risk for overexposure to ultraviolet (UV) radiation, a leading factor in the development of skin cancer. The majority of these individuals continue to protect themselves minimally and tan intentionally, including significant increases in tanning booth use recently. Such care-free behaviors exist despite widespread education/awareness about UV radiation and skin cancer. The purpose of the proposed project is to investigate the efficacy and longevity of two novel approaches to changing skin protection behaviors: 1) UV-detect photos that reveal currently existing skin damage and 2) motivational interviewing (MI), a person-centered, yet directive counseling style used to enhance internal motivation to change health behaviors. The proposed investigations include a pilot study to refine the methodology; a small formal randomized controlled efficacy trial; and a dismantling study. These studies will also expand current knowledge and research in several major ways: 1) the use of UV-detect photos will enable highly salient and personalized feedback, 2) MI will be used in a previously untried health domain (skin cancer prevention), 3) objective skin color changes will be measured using state-of-the-art skin reflectance spectrophotometry, and 4) the proposed studies will test aspects of several major psychological theories (e.g., Transtheoretical Model, Prototype/Willingness Model) to identify moderators/mediators of outcome. Therefore, the studies should provide useful information about process and outcome for skin cancer prevention researchers and clinicians. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Skin Cancer Prevention | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | June 2010 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 24 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00709306 | ||||
| Other Study ID Numbers ICMJE | K07CA108685 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Carolyn Heckman, Associate Member, Fox Chase Cancer Center | ||||
| Study Sponsor ICMJE | Fox Chase Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Fox Chase Cancer Center | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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