ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Cancer Screening and Education at Beaches (SHADE)

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: NCT00894855
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : December 31, 2014
Sponsor:
Collaborators:
The Shilling SHADE Foundation of America
University of Massachusetts, Amherst
Harvard Medical School
Brigham and Women's Hospital
Information provided by (Responsible Party):
Karen Emmons, PhD, Dana-Farber Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Skin Cancer Behavioral: education about sun protection Behavioral: biometric feedback Other: dermatologist skin exam Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Skin Cancer Screening and Education Program at Beaches
Study Start Date : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

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.
Behavioral: education about sun protection
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".
Other: dermatologist skin exam
Full body skin exam.

Experimental: educ, biometric fb, and derm skin exam
Participants received the active components of the other three conditions.
Behavioral: biometric feedback
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.

Other: dermatologist skin exam
Full body skin exam.

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.
Behavioral: biometric feedback
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.




Primary Outcome Measures :
  1. sun protection behaviors [ Time Frame: 4-6 months post-intervention ]
  2. sun burns [ Time Frame: 4-6 months post-intervention ]
  3. skin self-exams [ Time Frame: 4-6 months post-intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894855


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
The Shilling SHADE Foundation of America
University of Massachusetts, Amherst
Harvard Medical School
Brigham and Women's Hospital
Investigators
Principal Investigator: Karen M Emmons, PhD Dana-Farber Cancer Institute

Responsible Party: Karen Emmons, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00894855     History of Changes
Other Study ID Numbers: 14598
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Karen Emmons, PhD, Dana-Farber Cancer Institute:
skin cancer prevention
SHADE
Beach

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases