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NCT03979872: RISE-UP

Risk Information and Skin-cancer Education for Undergraduate Prevention

Completed NA Results posted Last updated 13 July 2021
What this trial tests

NA trial testing MC1R Genetic Testing in Melanoma in 92 participants. Completed in 1 August 2020.

Timeline
9 September 2019
Primary endpoint
7 April 2020
1 August 2020

Quick facts

Lead sponsorUniversity of Utah
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment92
Start date9 September 2019
Primary completion7 April 2020
Estimated completion1 August 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

18 and older, any sex, with Melanoma or Young Adult. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sun Protection Behaviors Assessed Via Questionnaires Primary · Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

Mean and standard deviation for each sun protection behavior at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "These next questions ask about what you have done in the past four weeks if you were outdoors in the sun for 15 minutes or more. How often did you... " Minimum value =1; Maximum value= 5; Higher scores indicate that participants were more likely to engage in sun protection habits.

Sun Protection- Sunscreen Visit 1
GroupValue95% CI
Arm 1: Skin Cancer Education Only2.4± 1.2
Arm 2: Skin Cancer Education + UV Photo3.0± 1.2
Arm 3: Skin Cancer Education + MC1R Testing2.8± 1.3
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing2.3± 1.1
Sun Protection- Sunscreen Visit 2
GroupValue95% CI
Arm 1: Skin Cancer Education Only2.4± 1.0
Arm 2: Skin Cancer Education + UV Photo2.4± 1.4
Arm 3: Skin Cancer Education + MC1R Testing2.7± 1.4
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing2.1± 1.2
Sun Protection- Sunscreen Visit 3
GroupValue95% CI
Arm 1: Skin Cancer Education Only2.3± 1.3
Arm 2: Skin Cancer Education + UV Photo2.9± 1.2
Arm 3: Skin Cancer Education + MC1R Testing2.3± 1.6
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing2.2± 1.1
Sun Protection- Reapply sunscreen Visit 1
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.6± 1.0
Arm 2: Skin Cancer Education + UV Photo1.9± 1.0
Arm 3: Skin Cancer Education + MC1R Testing2.0± 1.1
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.9± 0.8
Sun Protection- Reapply sunscreen Visit 2
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.6± 1.1
Arm 2: Skin Cancer Education + UV Photo1.6± 0.9
Arm 3: Skin Cancer Education + MC1R Testing1.8± 1.1
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.3± 0.6
Sun Protection- Reapply sunscreen Visit 3
GroupValue95% CI
Arm 1: Skin Cancer Education Only2.2± 1.1
Arm 2: Skin Cancer Education + UV Photo1.5± 1.0
Arm 3: Skin Cancer Education + MC1R Testing1.7± 1.1
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.6± 1.0
Sun Protection- Shirt with sleeves Visit 1
GroupValue95% CI
Arm 1: Skin Cancer Education Only3.9± 1.1
Arm 2: Skin Cancer Education + UV Photo4.0± 0.9
Arm 3: Skin Cancer Education + MC1R Testing4.0± 0.9
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing3.6± 1.5
Sun Protection- Shirt with sleeves Visit 2
GroupValue95% CI
Arm 1: Skin Cancer Education Only3.8± 1.2
Arm 2: Skin Cancer Education + UV Photo3.9± 1.5
Arm 3: Skin Cancer Education + MC1R Testing4.1± 1.1
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing4.1± 1.0
Sunburn Occurrence Assessed Via Questionnaire Secondary · Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

Average number of sunburns received by participants in the past 4 weeks when asked at Visit 1 (baseline), Visit 2 (4 weeks), and Visit 3 (8 weeks)

Visit 1
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.14± .468
Arm 2: Skin Cancer Education + UV Photo1.30± .559
Arm 3: Skin Cancer Education + MC1R Testing1.38± .875
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.13± .458
Visit 2
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.50± 1.192
Arm 2: Skin Cancer Education + UV Photo1.25± .716
Arm 3: Skin Cancer Education + MC1R Testing1.23± .528
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.05± .213
Visit 3
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.63± 1.300
Arm 2: Skin Cancer Education + UV Photo1.67± 1.175
Arm 3: Skin Cancer Education + MC1R Testing1.06± .236
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.16± .501
Intentional Outdoor Tanning Occurrence Assessed Via Questionnaire Secondary · Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

Mean and standard deviation for intentional outdoor tanning occurrences at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "In the past 4 Weeks, how often did you spend time in the sun in order to get tan?" Minimum value =1; Maximum value= 5; Higher scores indicates that participants spent more time outdoors to get a tan.

Visit 1
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.8± 1.1
Arm 2: Skin Cancer Education + UV Photo1.4± 0.8
Arm 3: Skin Cancer Education + MC1R Testing1.5± 1.1
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.6± 0.9
Visit 2
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.4± 0.8
Arm 2: Skin Cancer Education + UV Photo1.2± 0.5
Arm 3: Skin Cancer Education + MC1R Testing1.4± 0.7
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.4± 0.9
Visit 3
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.7± 1.2
Arm 2: Skin Cancer Education + UV Photo1.3± 0.8
Arm 3: Skin Cancer Education + MC1R Testing1.1± 0.5
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.5± 0.8
Intentional Indoor Tanning Occurrence Assessed Via Questionnaire Secondary · Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

Number of times participant used an indoor tanning device in the past 4 weeks when asked at Visit 1 (baseline), Visit 2 (4 weeks), and Visit 3 (8 weeks)

Visit 1
GroupValue95% CI
Arm 1: Skin Cancer Education Only22
Arm 2: Skin Cancer Education + UV Photo23
Arm 3: Skin Cancer Education + MC1R Testing24
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing23
Arm 1: Skin Cancer Education Only0
Arm 2: Skin Cancer Education + UV Photo0
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing0
Arm 1: Skin Cancer Education Only0
Arm 2: Skin Cancer Education + UV Photo0
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing0
Arm 1: Skin Cancer Education Only0
Arm 2: Skin Cancer Education + UV Photo0
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing0
Visit 2
GroupValue95% CI
Arm 1: Skin Cancer Education Only19
Arm 2: Skin Cancer Education + UV Photo19
Arm 3: Skin Cancer Education + MC1R Testing22
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing21
Arm 1: Skin Cancer Education Only0
Arm 2: Skin Cancer Education + UV Photo1
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing0
Arm 1: Skin Cancer Education Only0
Arm 2: Skin Cancer Education + UV Photo0
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1
Arm 1: Skin Cancer Education Only1
Arm 2: Skin Cancer Education + UV Photo0
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing0
Visit 3
GroupValue95% CI
Arm 1: Skin Cancer Education Only17
Arm 2: Skin Cancer Education + UV Photo13
Arm 3: Skin Cancer Education + MC1R Testing18
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing17
Arm 1: Skin Cancer Education Only1
Arm 2: Skin Cancer Education + UV Photo1
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1
Arm 1: Skin Cancer Education Only0
Arm 2: Skin Cancer Education + UV Photo1
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1
Arm 1: Skin Cancer Education Only1
Arm 2: Skin Cancer Education + UV Photo0
Arm 3: Skin Cancer Education + MC1R Testing0
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing0
Tan Occurrence Assessed Via Questionnaire Secondary · Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

Mean and standard deviation for tan occurrence at Visit 1 (baseline), Visit 2 (4 weeks), Visit 3 (8 weeks). "In the past 4 weeks, how often did you end up with a tan, even if you didn't try to get one?" Minimum value =1; Maximum value= 5; Higher scores indicate that participants received a tan as a result or being outdoors or using an indoor tanning device whether intentional or not.

Visit 1
GroupValue95% CI
Arm 1: Skin Cancer Education Only2.3± 1.2
Arm 2: Skin Cancer Education + UV Photo2.0± 1.9
Arm 3: Skin Cancer Education + MC1R Testing2.1± 1.3
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing2.0± 1.0
Visit 2
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.8± 1.1
Arm 2: Skin Cancer Education + UV Photo1.6± 1.0
Arm 3: Skin Cancer Education + MC1R Testing1.8± 1.3
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.7± 1.0
Visit 3
GroupValue95% CI
Arm 1: Skin Cancer Education Only1.9± 1.1
Arm 2: Skin Cancer Education + UV Photo1.2± 0.6
Arm 3: Skin Cancer Education + MC1R Testing1.2± 0.4
Arm 4: Skin Cancer Education + UV Photo + MC1R Testing1.6± 1.0

Sponsor's own description

The purpose of this study will be to provide undergraduate students information about skin cancer risk and prevention. The study will last between 2-3 months. Everyone in the study will be asked to answer questionnaires and receive education about skin cancer risk factors and prevention. We will follow-up with participants by phone, text messages or e-mail in between study visits Participants will be randomly assigned to one of four groups, the group will be in is decided by chance. Participant will either be assigned to: * A group that gets advice about what causes skin cancer and how to prevent it * A group that gets this advice and provides a saliva sample to receive personalized skin cancer risk genetic testing results * A group that gets this advice and receives a personalized photo that shows existing skin damage * A group that gets this advice, receives genetic testing results, and receives a personalized photo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Increasing Skin Cancer Prevention in Young Adults: the Cumulative Impact of Personalized UV Photography and MC1R Genetic Testing.
    Wu YP, Hamilton JG, Kaphingst KA, Jensen JD, et al · · 2023 · cited 9× · PMID 36306029 · DOI 10.1007/s13187-022-02232-1

Verify or expand the search:

Other recruiting trials for Melanoma

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03979872.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing