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Skin CancerPhase 3RISE-UPNCT05634252

Undergraduate Skin Cancer Prevention Trial

A Phase 3 study testing Education, Action Plan and UV Photo in people with Skin Cancer, run by University of Utah at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Skin Cancer
What is being tested?
Education, Action Plan and UV Photo
Could I receive a placebo?
No, everyone receives an active treatment
How many people
528 participants
Where
1 siteUnited States
Study dates
24 Apr 2023to 4 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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").

Who cannot join

  • Do not read or speak English
  • Self-reported personal history of skin cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Risk Information and Skin-Cancer Education and Undergraduate Prevention Trial

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.

Read the 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.

Conditions
Skin Cancer
Being tested
Education, Action Plan, UV Photo, MC1R Test
Keywords
Young Adults, Sunburn, Tanning
Medical subject headings
Skin Neoplasms, Sunburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationBehavioural

    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 PlanBehavioural

    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 PhotoBehavioural

    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 TestBehavioural

    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 groups in NCT05634252
Study groupRoleWhat they receive
Education + Action Plan + UV Photo + MC1R TestExperimentalStudents 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.
Receives: Behavioral: Education; Behavioral: Action Plan; Behavioral: UV Photo; Behavioral: MC1R Test
Education + Action Plan + UV PhotoExperimentalStudents 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.
Receives: Behavioral: Education; Behavioral: Action Plan; Behavioral: UV Photo
Education + Action Plan + MC1R TestExperimentalStudents 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.
Receives: Behavioral: Education; Behavioral: Action Plan; Behavioral: MC1R Test
Education + Action PlanExperimentalStudents 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.
Receives: Behavioral: Education; Behavioral: Action Plan
Education + UV Photo + MC1R TestExperimentalStudents 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.
Receives: Behavioral: Education; Behavioral: UV Photo; Behavioral: MC1R Test
Education + UV PhotoExperimentalStudents 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.
Receives: Behavioral: Education; Behavioral: UV Photo
Education + MC1R TestExperimentalStudents 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.
Receives: Behavioral: Education; Behavioral: MC1R Test
EducationExperimentalStudents in this intervention will receive education on skin cancer and prevention strategies.
Receives: Behavioral: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Sunburn Occurrence

    Participants will report on the number of sunburns they experienced using an item from the Sun Habits Survey: "In the past month, how many times did you have a red or painful sunburn that lasted a day or more?"

    Measured: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

Secondary outcomes (4)

  1. Change in Sun Protection Behaviors

    Participants will report on their use of sun protection using the Sun Habits Survey. Items will be modified to reflect the reporting period relevant for the current study (past month), to assess recommended sun protection behaviors not included in the original Sun Habits Survey (e.g., sunscreen re-application), and to assess sun protection separately for weekdays and weekends. All items are assessed on a 5-point Likert-type scale ("never" to "always").

    Measured: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

  2. Change in Intentional Tanning Behaviors

    Self-reported indoor and outdoor tanning behaviors will be assessed. Frequency of intentional indoor and outdoor tanning in the past month will be assessed using items from a well-established indoor tanning measure and the Sun Habits Survey. All items are assessed on a 5-point Likert-type scale ("never" to "always").

    Measured: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

  3. Change in Unintentional Tanning Behaviors

    Unintentional outdoor tanning (i.e., ending up with a tan when the student was not trying to get tan) will also be assessed. All items are assessed on a 5-point Likert-type scale ("never" to "always").

    Measured: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

  4. Change in UVR Exposure

    Participants will be asked to wear a UVR monitoring device for 7-day periods, a monitoring length consistent with prior studies and that captures both weekday and weekend exposure, immediately after each of the 4 assessments.

    Measured: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start24 Apr 2023
  3. Primary completion4 Sep 2027 (estimated)
  4. Study completion4 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
528 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634252
Sponsor's protocol ID
IRB_00157778
Acronym
RISE-UP
Status last verified
Jul 2026
First submitted
21 Nov 2022
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu YP, Woodside LA, Kaphingst KA, Jensen JD, Hamilton JG, Kohlmann W, Haaland B, Brintz BJ, Phillips SM, Hay JL. The Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP) Study: Protocol for a Trial of Personalized Sun Protection Interventions for Skin Cancer Prevention among Undergraduate Students. Contemp Clin Trials. 2024 Dec;147:107728. doi: 10.1016/j.cct.2024.107728. Epub 2024 Nov 2.

    PubMed 39491719

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Education, Action Plan and UV Photo in people with Skin Cancer, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sunburn Occurrence (time frame: Baseline, 1-month post-intervention, 3-months post-intervention, 15-months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634252, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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