Undergraduate Skin Cancer Prevention Trial

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05634252
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Education — BEHAVIORAL
    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.
  • Action Plan — BEHAVIORAL
    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.
  • UV Photo — BEHAVIORAL
    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.
  • MC1R Test — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 24, 2023
Status verified
Dec 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
528 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Education + Action Plan + UV Photo + MC1R Test
    Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
  • Experimental: Education + Action Plan + UV Photo
    Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.
  • Experimental: Education + Action Plan + MC1R Test
    Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
  • Experimental: Education + Action Plan
    Students in this intervention will receive education on skin cancer and prevention strategies and complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure.
  • Experimental: Education + UV Photo + MC1R Test
    Students in this intervention will receive education on skin cancer and prevention strategies, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
  • Experimental: Education + UV Photo
    Students in this intervention will receive education on skin cancer and prevention strategies and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.
  • Experimental: Education + MC1R Test
    Students in this intervention will receive education on skin cancer and prevention strategies and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.
  • Experimental: Education
    Students in this intervention will receive education on skin cancer and prevention strategies.

Primary Outcome Measure

Change in Sunburn Occurrence [ Time Frame: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112
Benjamin Weitzman, B.S.
734-881-5888
Yelena Wu, PhD (PRINCIPAL_INVESTIGATOR)

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