Sun Safety Ink! A Sun Safety Program for the Tattoo Community

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.

Study Overview

• Status: Completed
• Conditions: Skin Cancer
• Intervention / Treatment: Behavioral: Sun Safety Ink! Program; Behavioral: Attention Control

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.

• Study Type: Interventional
• Enrollment (Actual): 1820
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Golden, Colorado, United States, 80401
      • Klein Buendel, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sun Safety Ink! Program; 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.	Behavioral: Sun Safety Ink! Program; 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.
ACTIVE_COMPARATOR: Attention Control; The attention control group will provide standard tattoo aftercare instructions to their clients.	Behavioral: Attention Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 Month Posttest, 6 Month Posttest
Change in Number of Sunburns	Participants will report number of sunburns in the past 12 months.	Baseline, 1 Month Posttest, 6 Month Posttest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tanning Behaviors (online survey)	Participants will complete an online survey that focuses on tanning frequency for both indoor and outdoor tanning.	Baseline, 1 Month Posttest, 6 Month Posttest
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).	Baseline, 1 Month Posttest, 6 Month Posttest

Collaborators and Investigators

• Sponsor: Klein Buendel, Inc.
• Collaborators: National Cancer Institute (NCI); University of Colorado, Denver
• Investigators: Principal Investigator: Barbara Walkosz, PhD, Klein Buendel, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2017
• Primary Completion (ACTUAL): December 31, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Skin Cancer; Tattoo
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 0315; R01CA206569 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No