- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00894855
Skin Cancer Screening and Education at Beaches (SHADE)
December 30, 2014 updated by: Karen Emmons, PhD, Dana-Farber Cancer Institute
Skin Cancer Screening and Education Program at Beaches
This study was an evaluation of the Dana-Farber Cancer Institute Blum Family Resource Center Van's existing skin cancer screening and education program.
This program occurred over 2 summers.
This study will fill a critical gap in the investigators' knowledge about how best to address the high-risk behaviors that regularly occur during the summertime at beaches.
The investigators randomized beaches to receive different combinations of the van program components in order to determine how services should optimally be configured to maximize impact.
The investigators hypothesized that providing all three components (1-Skin cancer prevention education; 2-Biometric feedback using a Dermascan Analyzer that illustrates skin damage due to sun exposure and Ultra Violet (UV) Reflectance Photography; and 3-Dermatologist skin exam) will maximize knowledge and behavior change, relative to education alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
634
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Beachgoers eligible to participate in the study included:
- those who were 18 years and older
- Caucasian
- able to understand, speak and read English
- ability to give informed consent
- had not already enrolled in the study at another participating beach
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: education only
This comprehensive education program included a health educator visit, on the education van, who gave education about sun safety.
|
This comprehensive education program included a visit with a health educator, on the education van, who gave education about sun safety.
|
Experimental: education plus dermatologist skin exam
In addition to the education program, participants received free skin exams by board certified dermatologists from Brigham and Women's Hospital.
The van was equipped with a private clinical setting conducive to carry out such examinations.
Based on the recommendations of the American Academy of Dermatology (AAD), a visual full body exam was provided to participants.
At the end of each skin exam the dermatologist provided a presumptive diagnosis to the participant, and made appropriate recommendations and referrals for follow up with the participants' physician/dermatologist (if and when necessary).
All participants undergoing the skin exam were required to complete an "AAD Skin Cancer Screening Registration and Report form".
|
Full body skin exam.
|
Experimental: educ, biometric fb, and derm skin exam
Participants received the active components of the other three conditions.
|
Full body skin exam.
Participants received biometric feedback using a Dermascan Analyzer and Ultra Violet (UV) Reflectance Photography.
The Dermascan Analyzer is an educational tool that enhances visibility of skin texture, markings or lesions and is commonly used in health fairs and at schools all over the country.
The analyzer highlights the sun damage on the participants skin as dark purple blotches, which the participants are able to see in the mirror placed inside the analyzer.
Ultra Violet (UV) Reflectance Photography provides participants with a visual image of their skin damage that can be taken with them.
|
Experimental: education plus biometric feedback
In addition to the educational program, participants received biometric feedback using a Dermascan Analyzer and Ultra Violet (UV) Reflectance Photography.
The Dermascan Analyzer is an educational tool that enhances visibility of skin texture, markings or lesions and is commonly used in health fairs and at schools all over the country.
The analyzer highlights the sun damage on the participants skin as dark purple blotches, which the participants are able to see in the mirror placed inside the analyzer.
Ultra Violet (UV) Reflectance Photography provides participants with a visual image of their skin damage that can be taken with them.
|
Participants received biometric feedback using a Dermascan Analyzer and Ultra Violet (UV) Reflectance Photography.
The Dermascan Analyzer is an educational tool that enhances visibility of skin texture, markings or lesions and is commonly used in health fairs and at schools all over the country.
The analyzer highlights the sun damage on the participants skin as dark purple blotches, which the participants are able to see in the mirror placed inside the analyzer.
Ultra Violet (UV) Reflectance Photography provides participants with a visual image of their skin damage that can be taken with them.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sun protection behaviors
Time Frame: 4-6 months post-intervention
|
4-6 months post-intervention
|
sun burns
Time Frame: 4-6 months post-intervention
|
4-6 months post-intervention
|
skin self-exams
Time Frame: 4-6 months post-intervention
|
4-6 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen M Emmons, PhD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
May 6, 2009
First Submitted That Met QC Criteria
May 6, 2009
First Posted (Estimate)
May 7, 2009
Study Record Updates
Last Update Posted (Estimate)
December 31, 2014
Last Update Submitted That Met QC Criteria
December 30, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14598
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Cancer
-
University of HawaiiVA Palo Alto Health Care SystemCompletedCancer, Other Than Non-melanoma Skin CancerUnited States
-
EnlundCompletedBreast Cancer | Skin Cancer | Colo-rectal CancerSweden
-
McMaster UniversityRecruitingSkin Cancer, Basal Cell Skin Cancer Skin Cancer, Non-Melanoma Skin Cancers - Squamous Cell Carcinoma Patient SatisfactionCanada
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)CompletedSkin Cancer PreventionUnited States
-
SciBase ABRecruitingKeratinocyte Skin CancerGermany
-
Rutgers, The State University of New JerseyCompleted
-
University of MichiganBlue Cross Blue Shield of Michigan FoundationCompletedSkin Cancer PreventionUnited States
-
Xoft, Inc.Eminence Clinical Research, Inc.UnknownNonmelanoma Skin CancerUnited States
-
OncoBeta TherapeuticsRecruitingNon-melanoma Skin CancerAustralia
-
University of Alabama at BirminghamNational Cancer Institute (NCI); National Institutes of Health (NIH)Active, not recruitingNon-melanoma Skin CancerUnited States
Clinical Trials on education about sun protection
-
Northwestern UniversityCompletedDisorder Related to Renal Transplantation | Unspecified Complication of Kidney TransplantUnited States
-
Northwestern UniversityCompletedSkin Cancer | Sun Sensitivity | Sun ProtectionUnited States
-
University of OsloCompleted
-
Saglik Bilimleri UniversitesiNot yet recruiting
-
NovoBliss Research Pvt LtdCompletedValidation of the Process of Skin TanningIndia
-
Akdeniz UniversityCompletedParents | Skin Neoplasms | Child Behavior | Health Behavior | Behavior and Behavior MechanismsTurkey
-
Centre Hospitalier Universitaire de la RéunionCompleted
-
Spirig Pharma Ltd.TerminatedActinic Keratoses | Squamous Cell CarcinomasIreland, Austria, Netherlands, United Kingdom, Czech Republic, France, Germany, Switzerland, Turkey
-
Chinese University of Hong KongRecruitingInternet Gaming DisorderChina, Hong Kong
-
University of ZurichZürcher Rheumastifung, Zurich, Switzerland; Gertrude and Wolfgang Schrader... and other collaboratorsCompletedRheumatoid ArthritisSwitzerland