Skin CancerSHADENCT00894855
Skin Cancer Screening and Education at Beaches
A study testing education about sun protection, biometric feedback and dermatologist skin exam in people with Skin Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- education about sun protection, biometric feedback and dermatologist skin exam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Skin Cancer
- Being tested
- education about sun protection, biometric feedback, dermatologist skin exam
- Keywords
- skin cancer prevention, SHADE, Beach
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education about sun protectionBehavioural
This comprehensive education program included a visit with a health educator, on the education van, who gave education about sun safety.
biometric feedbackBehavioural
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.
dermatologist skin examOther
Full body skin exam.
| Study group | Role | What they receive |
|---|---|---|
| education only | Active comparator | This comprehensive education program included a health educator visit, on the education van, who gave education about sun safety. Receives: Behavioral: education about sun protection |
| education plus dermatologist skin exam | Experimental | 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". Receives: Other: dermatologist skin exam |
| educ, biometric fb, and derm skin exam | Experimental | Participants received the active components of the other three conditions. Receives: Behavioral: biometric feedback; Other: dermatologist skin exam |
| education plus biometric feedback | Experimental | 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. Receives: Behavioral: biometric feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
sun protection behaviors
Measured: 4-6 months post-intervention
sun burns
Measured: 4-6 months post-intervention
skin self-exams
Measured: 4-6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Shilling SHADE Foundation of America, University of Massachusetts, Amherst, Harvard Medical School (HMS and HSDM), Brigham and Women's Hospital
- Responsible party
- Principal investigator, Karen Emmons, PhD, Dana-Farber Cancer Institute
- Investigators
- Karen M Emmons, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894855
- Sponsor's protocol ID
- 14598
- Acronym
- SHADE
- Status last verified
- Dec 2014
- First submitted
- 6 May 2009
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Cancer Screening and Education Program at Beaches
- ClinicalTrials.gov ID
- NCT00894855
- Acronym / sponsor ID
- SHADE / 14598
- Conditions
- Skin Cancer
- Keywords
- skin cancer prevention, SHADE, Beach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- The Shilling SHADE Foundation of America, University of Massachusetts, Amherst, Harvard Medical School (HMS and HSDM), Brigham and Women's Hospital
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| education only | Active comparator | Behavioral: education about sun protectionThis comprehensive education program included a health educator visit, on the education van, who gave education about sun safety. |
| education plus dermatologist skin exam | Experimental | Other: dermatologist skin examIn 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". |
| educ, biometric fb, and derm skin exam | Experimental | Behavioral: biometric feedback, Other: dermatologist skin examParticipants received the active components of the other three conditions. |
| education plus biometric feedback | Experimental | Behavioral: biometric feedbackIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Beachgoers eligible to participate in the study included:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education about sun protectionThis comprehensive education program included a visit with a health educator, on the education van, who gave education about sun safety. | Behavioural | education only |
| biometric feedbackParticipants 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. | Behavioural | educ, biometric fb, and derm skin exam, education plus biometric feedback |
| dermatologist skin examFull body skin exam. | Other | educ, biometric fb, and derm skin exam, education plus dermatologist skin exam |
Primary outcome
sun protection behaviors
Time frame: 4-6 months post-intervention
sun burns
Time frame: 4-6 months post-intervention
skin self-exams
Time frame: 4-6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Emmons, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education about sun protection, biometric feedback and dermatologist skin exam in people with Skin Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sun protection behaviors (time frame: 4-6 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.