NCT03096548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,820

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

5.5 years

First QC Date

March 14, 2017

Last Update Submit

February 2, 2023

Conditions

Skin Cancer

Keywords

Skin CancerTattoo

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in Tanning Behaviors (online survey)

    Baseline, 1 Month Posttest, 6 Month Posttest

  • Change in Tanning Attitudes (online survey)

    Baseline, 1 Month Posttest, 6 Month Posttest

Study Arms (2)

Sun Safety Ink! Program

EXPERIMENTAL

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

Attention Control

ACTIVE COMPARATOR

The attention control group will provide standard tattoo aftercare instructions to their clients.

Behavioral: Attention Control

Interventions

Sun Safety Ink! ProgramBEHAVIORAL

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.

Sun Safety Ink! Program
Attention ControlBEHAVIORAL

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.

Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 years of age or older
  • Must have received a tattoo in a licensed tattoo studio

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Barbara Walkosz, PhD

    Klein Buendel, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 30, 2017

Study Start

June 15, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)