Skin Cancer Screening and Education at Beaches (SHADE)

This study has been completed.
Sponsor:
Collaborators:
The Shilling SHADE Foundation of America
University of Massachusetts, Amherst
Harvard University
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00894855
First received: May 6, 2009
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

This study is an evaluation of the Dana-Farber Cancer Institute Blum Family Resource Center Van's existing skin cancer screening and education program. This program has been on-going over the past 2 summers, and although it has provided substantial service, there has been no evaluation of its impact on skin cancer prevention knowledge or behaviors. Thus, 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 Intervention
Skin Cancer
Behavioral: education about sun protection
Behavioral: biometric feedback
Other: dermatologist skin exam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Skin Cancer Screening and Education Program at Beaches

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • sun protection behaviors [ Time Frame: 4-6 months post-intervention ] [ Designated as safety issue: No ]
  • sun burns [ Time Frame: 4-6 months post-intervention ] [ Designated as safety issue: No ]
  • skin self-exams [ Time Frame: 4-6 months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 634
Study Start Date: January 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: education only
This comprehensive education program includes sitting down with a health educator and getting educated about sun safety. Participants received sun safety education on the education van, offered by trained health educators.
Behavioral: education about sun protection
This comprehensive education program includes sitting down with a health educator and getting educated about sun safety. Participants received sun safety education on the education van, offered by trained health educators.
Experimental: education plus dermatologist skin exam
In addition to the education program, participants receive free skin exams by board certified dermatologists from Brigham and Women's Hospital. The van is 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 receive 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 University
Brigham and Women's Hospital
Investigators
Principal Investigator: Karen M Emmons, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Karen M. Emmons, Ph.D., Professor, DFCI
ClinicalTrials.gov Identifier: NCT00894855     History of Changes
Other Study ID Numbers: 14598
Study First Received: May 6, 2009
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
skin cancer prevention
SHADE
Beach

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

ClinicalTrials.gov processed this record on September 22, 2014