Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03096548 |
| Other study ID # |
0315 |
| Secondary ID |
R01CA206569 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2017 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Klein Buendel, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
