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Skin Cancer Screening and Education at Beaches (SHADE)

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
education about sun protection
biometric feedback
dermatologist skin exam
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer focused on measuring skin cancer prevention, SHADE, Beach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

education only

education plus dermatologist skin exam

educ, biometric fb, and derm skin exam

education plus biometric feedback

Arm Description

This comprehensive education program included a health educator visit, on the education van, who gave education about sun safety.

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".

Participants received the active components of the other three conditions.

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.

Outcomes

Primary Outcome Measures

sun protection behaviors
sun burns
skin self-exams

Secondary Outcome Measures

Full Information

First Posted
May 6, 2009
Last Updated
December 30, 2014
Sponsor
Dana-Farber Cancer Institute
Collaborators
The Shilling SHADE Foundation of America, University of Massachusetts, Amherst, Harvard Medical School (HMS and HSDM), Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00894855
Brief Title
Skin Cancer Screening and Education at Beaches
Acronym
SHADE
Official Title
Skin Cancer Screening and Education Program at Beaches
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
The Shilling SHADE Foundation of America, University of Massachusetts, Amherst, Harvard Medical School (HMS and HSDM), Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
skin cancer prevention, SHADE, Beach

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
634 (Actual)

8. Arms, Groups, and Interventions

Arm Title
education only
Arm Type
Active Comparator
Arm Description
This comprehensive education program included a health educator visit, on the education van, who gave education about sun safety.
Arm Title
education plus dermatologist skin exam
Arm Type
Experimental
Arm Description
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".
Arm Title
educ, biometric fb, and derm skin exam
Arm Type
Experimental
Arm Description
Participants received the active components of the other three conditions.
Arm Title
education plus biometric feedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
education about sun protection
Intervention Description
This comprehensive education program included a visit with a health educator, on the education van, who gave education about sun safety.
Intervention Type
Behavioral
Intervention Name(s)
biometric feedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
dermatologist skin exam
Intervention Description
Full body skin exam.
Primary Outcome Measure Information:
Title
sun protection behaviors
Time Frame
4-6 months post-intervention
Title
sun burns
Time Frame
4-6 months post-intervention
Title
skin self-exams
Time Frame
4-6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Emmons, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Skin Cancer Screening and Education at Beaches

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