Sun Safety Ink! A Sun Safety Program for the Tattoo Community
Primary Purpose
Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sun Safety Ink! Program
Attention Control
Sponsored by
About this trial
This is an interventional prevention trial for Skin Cancer focused on measuring Skin Cancer, Tattoo
Eligibility Criteria
Inclusion Criteria:
- Must be 18 years of age or older
- Must have received a tattoo in a licensed tattoo studio
Exclusion Criteria:
- Under 18 years of age
Sites / Locations
- University of Colorado Denver
- Klein Buendel, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sun Safety Ink! Program
Attention Control
Arm Description
A program to (1) increase full-body sun comprehensive sun protection practices, (2) decrease sunburning and tanning and (3) decrease positive attitudes regarding tanning and tanning attractiveness of tattoo studio clients. The program is comprised of a video based communication strategy training presented by research staff to artists of tattoo studios.
The attention control group will provide standard tattoo aftercare instructions to their clients.
Outcomes
Primary Outcome Measures
Change in Sun Protection by Client (online survey)
Sun protection practices (sunscreen application/reapplication and Sun Protection Factor (SPF); use of lip balm, hats, protective clothing, sunglasses, shade) of tattooed and non-tattooed skin will be assessed in an online survey.
Change in Number of Sunburns
Participants will report number of sunburns in the past 12 months.
Secondary Outcome Measures
Change in Tanning Behaviors (online survey)
Participants will complete an online survey that focuses on tanning frequency for both indoor and outdoor tanning.
Change in Tanning Attitudes (online survey)
Participants will complete an online survey that focuses on a six-item tanning image scale (1= strongly agree to 5= strongly disagree).
Full Information
NCT ID
NCT03096548
First Posted
March 14, 2017
Last Updated
February 2, 2023
Sponsor
Klein Buendel, Inc.
Collaborators
National Cancer Institute (NCI), University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03096548
Brief Title
Sun Safety Ink! A Sun Safety Program for the Tattoo Community
Official Title
Sun Safety Ink! A Sun Safety Program for the Tattoo Community
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Klein Buendel, Inc.
Collaborators
National Cancer Institute (NCI), University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Over 3.5 million cases of non-melanoma skin cancers occur annually and melanoma rates have doubled in the last 30 years, burdening the nation's health system. Klein Buendel, Inc. (KB) proposes to develop Sun Safety INK! (SSI!), a skin cancer prevention program targeted to clients of licensed tattoo studios because tattoo aftercare recommendations can include sun protection for tattoos, and studios offer an opportunity to reach younger adults who are significantly more likely to sunburn and less likely to practice sun safety. The study will assess the effectiveness of SSI! at (1) increasing full-body comprehensive sun protection practices; (2) decreasing sun burning and tanning; and, (3) decreasing positive attitudes regarding tanning and tanning attractiveness.
Detailed Description
Skin cancer prevention is a public health priority. Over 3.5 million cases of non-melanoma skin cancers (NMSC) occur annually and melanoma rates have doubled in the last 30 years, burdening the nation's health system. Increasing evidence points to the need for prevention programs to be targeted to young adults as invasive melanoma of the skin is the third most common cancer among adolescents and young adults (ages 15-39) in the U.S. Skin cancer is preventable as excess exposure to ultraviolet radiation (UVR), the primary risk factor, is modifiable and a number of public health campaigns have been developed to increase awareness about skin cancer risk and to promote sun safety. Despite these efforts, skin cancer rates continue to rise. Many adults still forget to apply sunscreen, do not pre-apply prior to sun exposure, fail to reapply, do not use clothing or wide-brimmed hats that physically block UVR and do not use shade. 4.2% of US adults engage in indoor tanning. It is well established that continued efforts are needed to promote skin cancer prevention. Concurrently, approximately, 25% of American adults have a tattoo with younger adults more likely to have tattoos than older adults. The popularity of tattoos continues to grow in the general population and particularly among members of the military. Individuals with tattoos need to take extra precaution when exposed to the sun not only to protect themselves from harmful UVR rays but also to reduce damage to their tattoos. Klein Buendel, Inc. (KB) proposes to develop and test Sun Safety INK (SSI), a skin cancer prevention program targeted to clients of licensed tattoo studios. The studios have been selected as the venue for this study because tattoo salons, at times, promote sun protection for new tattoos to keep them from fading, and offer a unique opportunity to reach younger adults who have high sunburn rates and are often less likely to practice sun protection. The studios provide a unique and compatible environment for sun safety promotion. Further, a number of successful programs have promoted health practices through similar venues such as beauty parlors and barber shops. Exploratory research with the tattoo community determined that: (1) tattoo studios were receptive to a skin cancer prevention program; (2) tattooed individuals had high rates of sunburns and low rates of sun protection but were open to receiving sun safety information and (3) a prototype SSI! program confirmed feasibility for recruitment and implementation. Based on these results, KB proposes to fully develop SSI! to include an online sun safety training for artists, a website, and additional sun safety education materials (e.g., social media). KB will work with the Alliance of Professional Tattoo Artists and the National Tattoo Association to recruit 30 licensed studios to participate in a group-randomized pair-matched pretest-posttest controlled quasi-experimental design. The primary outcomes of the study will be to evaluate the effectiveness of SSI! at: (1) increasing full-body comprehensive sun protection practices; (2) decreasing sun burning and tanning; and, (3) decreasing positive attitudes regarding tanning and tanning attractiveness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Skin Cancer, Tattoo
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1820 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sun Safety Ink! Program
Arm Type
Experimental
Arm Description
A program to (1) increase full-body sun comprehensive sun protection practices, (2) decrease sunburning and tanning and (3) decrease positive attitudes regarding tanning and tanning attractiveness of tattoo studio clients. The program is comprised of a video based communication strategy training presented by research staff to artists of tattoo studios.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
The attention control group will provide standard tattoo aftercare instructions to their clients.
Intervention Type
Behavioral
Intervention Name(s)
Sun Safety Ink! Program
Intervention Description
The intervention will be comprised of an online skin cancer prevention training for all tattoo artists of participating studios. The training will include skin cancer rates and risk factors, tattoo rates, recommendations for sun protection practices, a rationale for the relationship of tattoo care and sun safety, and recommended communication strategies for artists to communicate skin cancer prevention to their clients. Additional printed materials (tip-card for clients, posters) to be displayed in tattoo studios, a Sun Safety Ink! website, and social media messages for tattoo studios' Facebook and Pinterest pages will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Studios and artists in this attention control group will not receive the Sun Safety Ink! program. They will continue to provide standard aftercare instructions to clients. The program will be provided to them at the end of the study.
Primary Outcome Measure Information:
Title
Change in Sun Protection by Client (online survey)
Description
Sun protection practices (sunscreen application/reapplication and Sun Protection Factor (SPF); use of lip balm, hats, protective clothing, sunglasses, shade) of tattooed and non-tattooed skin will be assessed in an online survey.
Time Frame
Baseline, 1 Month Posttest, 6 Month Posttest
Title
Change in Number of Sunburns
Description
Participants will report number of sunburns in the past 12 months.
Time Frame
Baseline, 1 Month Posttest, 6 Month Posttest
Secondary Outcome Measure Information:
Title
Change in Tanning Behaviors (online survey)
Description
Participants will complete an online survey that focuses on tanning frequency for both indoor and outdoor tanning.
Time Frame
Baseline, 1 Month Posttest, 6 Month Posttest
Title
Change in Tanning Attitudes (online survey)
Description
Participants will complete an online survey that focuses on a six-item tanning image scale (1= strongly agree to 5= strongly disagree).
Time Frame
Baseline, 1 Month Posttest, 6 Month Posttest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be 18 years of age or older
Must have received a tattoo in a licensed tattoo studio
Exclusion Criteria:
Under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Walkosz, PhD
Organizational Affiliation
Klein Buendel, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Klein Buendel, Inc.
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sun Safety Ink! A Sun Safety Program for the Tattoo Community
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