NCT03979872

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 1, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

June 5, 2019

Results QC Date

April 9, 2021

Last Update Submit

July 9, 2021

Conditions

Keywords

Education PreventionMC1R Genetic Testing

Outcome Measures

Primary Outcomes (1)

  • Sun Protection Behaviors Assessed Via Questionnaires

    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.

    Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

Secondary Outcomes (4)

  • Sunburn Occurrence Assessed Via Questionnaire

    Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

  • Intentional Outdoor Tanning Occurrence Assessed Via Questionnaire

    Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

  • Intentional Indoor Tanning Occurrence Assessed Via Questionnaire

    Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

  • Tan Occurrence Assessed Via Questionnaire

    Weeks 0 (Visit 1), 4 (Visit 2), 8 (Visit 3)

Study Arms (4)

Arm 1: Skin Cancer Education Only

ACTIVE COMPARATOR

Participants will be randomized to receive education only.

Other: Skin Cancer Education

Arm 2: Skin Cancer Education + UV Photo

EXPERIMENTAL

Participants randomized to receive education + UV photo will have a UV light photo taken of their face to show UV damage in the skin that is invisible to the naked eye in addition to receiving skin cancer education.

Other: Skin Cancer EducationDevice: UV Photo

Arm 3: Skin Cancer Education + MC1R Testing

EXPERIMENTAL

Participants randomized to receive education + genetic testing will be asked to provide a saliva sample for MC1R testing in addition to receiving skin cancer education.

Diagnostic Test: MC1R Genetic TestingOther: Skin Cancer Education

Arm 4: Skin Cancer Education + UV Photo + MC1R Testing

EXPERIMENTAL

Participants randomized to receive education + UV photo + genetic testing will have a UV light photo taken of their face, Submit a saliva sample for MC1R testing, and receive skin cancer education.

Diagnostic Test: MC1R Genetic TestingOther: Skin Cancer EducationDevice: UV Photo

Interventions

MC1R Genetic TestingDIAGNOSTIC_TEST

\[See arm/group descriptions\]

Arm 3: Skin Cancer Education + MC1R TestingArm 4: Skin Cancer Education + UV Photo + MC1R Testing

\[See arm/group descriptions\]

Arm 1: Skin Cancer Education OnlyArm 2: Skin Cancer Education + UV PhotoArm 3: Skin Cancer Education + MC1R TestingArm 4: Skin Cancer Education + UV Photo + MC1R Testing
UV PhotoDEVICE

\[See arm/group descriptions\]

Arm 2: Skin Cancer Education + UV PhotoArm 4: Skin Cancer Education + UV Photo + MC1R Testing

Eligibility Criteria

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

You may qualify if:

  • Individual is enrolled in courses at the University of Utah
  • And
  • Individual reports having had at least 1 sunburn in the past year
  • And/or
  • Individual reports having intentionally indoor or outdoor tanned at lease 1 time in the past year
  • And/or
  • \- Individual reports using sunscreen plus 1 or more other following behaviors never/rarely/sometimes in the past month: 1)Protective clothing items, 2)Shade when outdoors

You may not qualify if:

  • Individual does not read/speak English
  • Individual reports a personal history of skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • Wu YP, Hamilton JG, Kaphingst KA, Jensen JD, Kohlmann W, Parsons BG, Lillie HM, Wang X, Haaland B, Wankier AP, Grossman D, Hay JL. Increasing Skin Cancer Prevention in Young Adults: the Cumulative Impact of Personalized UV Photography and MC1R Genetic Testing. J Cancer Educ. 2023 Jun;38(3):1059-1065. doi: 10.1007/s13187-022-02232-1. Epub 2022 Oct 28.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Yelena Wu
Organization
University of Utah

Study Officials

  • Yelena Wu, PHD

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 4 different parallel intervention groups: * Education only * Education + MC1R genetic testing * Education + UV photo * Education + MC1R genetic testing + UV photo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 7, 2019

Study Start

September 9, 2019

Primary Completion

April 7, 2020

Study Completion

August 1, 2020

Last Updated

July 13, 2021

Results First Posted

July 1, 2021

Record last verified: 2021-07

Locations