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Risk Information and Skin-cancer Education for Undergraduate Prevention (RISE-UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979872
Recruitment Status : Enrolling by invitation
First Posted : June 7, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Kimberly Kaphingst, University of Utah

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.

Condition or disease Intervention/treatment Phase
Melanoma Young Adult Diagnostic Test: MC1R Genetic Testing Other: Skin Cancer Education Device: UV Photo Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

4 different parallel intervention groups:

  • Education only
  • Education + MC1R genetic testing
  • Education + UV photo
  • Education + MC1R genetic testing + UV photo
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Risk Information and Skin-cancer Education for Undergraduate Prevention
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Active Comparator: Arm 1: Skin Cancer Education Only
Participants will be randomized to receive education only.
Other: Skin Cancer Education
[See arm/group descriptions]

Experimental: Arm 2: Skin Cancer Education + UV Photo
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 Education
[See arm/group descriptions]

Device: UV Photo
[See arm/group descriptions]

Experimental: Arm 3: Skin Cancer Education + MC1R Testing
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 Testing
[See arm/group descriptions]

Other: Skin Cancer Education
[See arm/group descriptions]

Experimental: Arm 4: Skin Cancer Education + UV Photo + MC1R Testing
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 Testing
[See arm/group descriptions]

Other: Skin Cancer Education
[See arm/group descriptions]

Device: UV Photo
[See arm/group descriptions]




Primary Outcome Measures :
  1. Sun Protection Behaviors Assessed Via Questionnaires [ Time Frame: 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 a better outcome



Secondary Outcome Measures :
  1. Sunburn Occurrence Assessed Via Questionnaire [ Time Frame: 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)

  2. Intentional Outdoor Tanning Occurrence Assessed Via Questionnaire [ Time Frame: 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 indicate a better outcome


  3. Intentional Indoor tanning Occurrence Assessed Via Questionnaire [ Time Frame: 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)

  4. Tan Occurrence Assessed Via Questionnaire [ Time Frame: 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 a better outcome




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979872


Locations
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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
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Responsible Party: Kimberly Kaphingst, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03979872    
Other Study ID Numbers: IRB_00116807
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kimberly Kaphingst, University of Utah:
Education Prevention
MC1R Genetic Testing
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases