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Trial Title:
Undergraduate Skin Cancer Prevention Trial
NCT ID:
NCT05634252
Condition:
Skin Cancer
Conditions: Official terms:
Skin Neoplasms
Conditions: Keywords:
Young Adults
Sunburn
Tanning
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Education
Description:
All conditions will receive education on skin cancer and strategies to prevention skin
cancer, including sun protection strategies and avoidance of intentional and
unintentional tanning.
Arm group label:
Education
Arm group label:
Education + Action Plan
Arm group label:
Education + Action Plan + MC1R Test
Arm group label:
Education + Action Plan + UV Photo
Arm group label:
Education + Action Plan + UV Photo + MC1R Test
Arm group label:
Education + MC1R Test
Arm group label:
Education + UV Photo
Arm group label:
Education + UV Photo + MC1R Test
Intervention type:
Behavioral
Intervention name:
Action Plan
Description:
Participants will be guided through a worksheet for creating a personalized action plan
for creating individualized sun protection and tanning plans for situations in which they
receive UVR exposure. For the tanning worksheet, participants who report any tanning
identify the locations at or activities during which they tan, select a tanning behavior
to plan for, and then are guided through the steps of making a specific plan for an
alternate activity that meets their goals while minimizing tanning and using sun
protection.
Arm group label:
Education + Action Plan
Arm group label:
Education + Action Plan + MC1R Test
Arm group label:
Education + Action Plan + UV Photo
Arm group label:
Education + Action Plan + UV Photo + MC1R Test
Intervention type:
Behavioral
Intervention name:
UV Photo
Description:
Participants will receive a printout of a photo of their face in visible light and UV
light from the VISIA Complexion Analysis system. Participants will receive a handout of
their photos accompanied by an explanation of UV light, its harmful effects on skin, and
that using sun safe behaviors early in life will have the greatest impact and help to
decrease risk for skin cancer.
Arm group label:
Education + Action Plan + UV Photo
Arm group label:
Education + Action Plan + UV Photo + MC1R Test
Arm group label:
Education + UV Photo
Arm group label:
Education + UV Photo + MC1R Test
Intervention type:
Behavioral
Intervention name:
MC1R Test
Description:
Participants will provide a saliva sample using an Oragene® clinical-grade saliva kit.
Once sequenced, participants will receive their MC1R testing results via web as well as a
standardized booklet that addresses personal risk level and population risk level,
strategies to reduce skin cancer risk, and number to call or email for further
information.
Arm group label:
Education + Action Plan + MC1R Test
Arm group label:
Education + Action Plan + UV Photo + MC1R Test
Arm group label:
Education + MC1R Test
Arm group label:
Education + UV Photo + MC1R Test
Summary:
The proposed study is a Multiphase Optimization Strategy (MOST) that uses factorial
experiments to evaluate individual and combined effects of intervention components to
improve intervention efficiency. The study team anticipates enrolling a total of 528
undergraduate students (>18 years) into the trial to identify intervention approaches
that eliminate sunburn, and secondarily to motivate sun protection and discourage
tanning. The study team will test personalized risk components: 1) UV Photo, 2) Action
Plan, and 3) MC1R Testing. A full factorial experiment will be conducted to test which of
the proposed components or their combinations eliminate sunburn over one year. The study
team will also examine effects of the intervention on secondary outcomes. Study
assessments will be completed at 4 time points: baseline, 1-month post-intervention,
4-months post-intervention, and 15-months post-intervention.
Detailed description:
The proposed study is a Multiphase Optimization Strategy (MOST) that uses factorial
experiments to evaluate individual and combined effects of intervention components to
improve intervention efficiency. The study team will use MOST to test an intervention
that has the potential to eliminate sunburn in higher-risk young people during the
highest risk times of the year. The study will enroll a total of 528 undergraduate
students (>18 years) total in Years 1 through 4 of the award period.
After students provide informed consent, they will complete a baseline assessment via the
REDCap data capture system on their sunburn occurrence, sun protection behaviors, and
tanning behaviors. Following the baseline assessment, students will be randomized to each
group using computer-generated randomly permuted blocks, stratified by sex and
unintentional/intentional tanning. There are three intervention components that are
candidates for inclusion in the optimized RISE-UP intervention: 1) UV Photo, 2) Action
Plan, and 3) MC1R Testing. All conditions will receive education on skin cancer and
strategies to prevention skin cancer, including sun protection strategies and avoidance
of intentional and unintentional tanning.
The optimized intervention will take place approximately one month after the baseline
assessment. Participants allocated to receive the UV photo will receive a printout photo
of their face in visible light and UV light from the VISIA Complexion Analysis system.
Participants who receive the action plan will complete an individualized sun protection
and tanning plan for situations in which they receive ultraviolet radiation (UVR)
exposure. Participants who are allocated to receive MC1R testing will be asked to provide
a saliva sample. Once sequenced, participants will receive their results that addresses
both their personal and population risk level.
One month after the optimized intervention, participants will be asked to complete
another assessment. Participants will also be asked to complete an additional follow-up
assessment 3 months later and at 15-months post-intervention. In total, participants will
be asked to complete 4 separate assessments. Participants will also be asked to wear a
UVR monitoring device for 7-day periods immediately after each of the 4 assessments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- At least 18 years old
- Enrolled as an undergraduate student
- Report having at least one sunburn in the last year, AND/OR having tanned indoors at
least once in the last year, AND/OR intentional or unintentional outdoor tanning
"sometimes," "often," or "always," AND/OR or using sunscreen plus one or more other
sun protection behavior (protective clothing use, shade use when outdoors)
infrequently ("never," "seldom," or "sometimes").
Exclusion Criteria:
- Do not read or speak English
- Self-reported personal history of skin cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Liberty Woodside
Phone:
734-881-5888
Email:
Liberty.Woodside@hci.utah.edu
Investigator:
Last name:
Yelena Wu, PhD
Email:
Principal Investigator
Start date:
April 24, 2023
Completion date:
June 2027
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Collaborator:
Agency:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Agency class:
NIH
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634252
