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Modifying Young Adult Skin Cancer Risk and Protective Behaviors (UV4me2)

Primary Purpose

Melanoma and Other Malignant Neoplasms of Skin

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UV4.me2
UV4.me
E-Pamphlet
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma and Other Malignant Neoplasms of Skin

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Moderate to high risk for skin cancer

Exclusion Criteria:

  • Not able to speak English
  • Past history of skin cancer

Sites / Locations

  • Rutgers Cancer Institute of New Jersey
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

E-Pamphlet

Original UV4.me

Enhanced UV4.me2

Arm Description

A free non-interactive e-pamphlet ("Skin Cancer Prevention and Early Detection" from the American Cancer Society) will be accessible via our website.

Participants will view the original UV4.me web intervention, which includes educational modules, personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individuals, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator. The website content will remain the same, with the exception of updating photos, statistics, and cultural references for the current year.

Participants will view an enhanced version of the UV4.me website. Improvements to the website are based on user feedback from the original UV4.me trial, as well as reviews and models of effective e-Health interventions and implementation strategies.

Outcomes

Primary Outcome Measures

Reach: eligibility by recruitment source.
The number of participants who are eligible for the study by recruitment source (i.e., skin protection organizations, Google Adwords, Facebook ads, consumer research panel, word of mouth).
Efficacy: Sun protection behaviors
Skin cancer-related behavioral outcomes will initially be assessed at baseline and 3 months later. Sun protection will be measured using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
Efficacy: UV exposure behaviors
Skin cancer-related behavioral outcomes will initially be assessed at baseline and 3 months later. UV exposure will be measured using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
Reach: enrollment by recruitment source.
The number of participants who enroll in the study by recruitment source (i.e., skin protection organizations, Google Adwords, Facebook ads, consumer research panel, word of mouth).

Secondary Outcome Measures

Maintenance of skin cancer-related behavioral outcomes (sun protection)
Sun protection behaviors will be assessed at 6 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
Maintenance of skin cancer-related behavioral outcomes (sun protection)
Sun protection behaviors will be assessed at 12 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
Maintenance of skin cancer-related behavioral outcomes (UV exposure)
UV exposure will be assessed at 6 months using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
Maintenance of skin cancer-related behavioral outcomes (UV exposure)
UV exposure will be assessed at 12 months using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
Implementation: Web intervention use frequency
How frequently participants logged into the interventions will be recorded.
Cost of interventions
Total costs of the interventions will be assessed.

Full Information

First Posted
October 4, 2017
Last Updated
September 27, 2022
Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of Pennsylvania, ITX Corporation, RTI International, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03313492
Brief Title
Modifying Young Adult Skin Cancer Risk and Protective Behaviors
Acronym
UV4me2
Official Title
Modifying Young Adult Skin Cancer Risk and Protective Behaviors (UV4.me2): A Hybrid Type 2 Dissemination/Effectiveness Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of Pennsylvania, ITX Corporation, RTI International, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Skin cancer is the most common cancer and can be deadly, debilitating, damaging, and disfiguring, yet is highly preventable. In 2014, the US Surgeon General made a call to action about the "major public health problem" of skin cancer, noting potential contributions of behavioral science and education, and a need for investments in such efforts. Almost five million Americans are treated for skin cancer annually, and incidence is rising. Risk factors for melanoma and non-melanoma skin cancers include personal or family history of skin cancer, certain physical characteristics (e.g., fair skin, numerous moles), as well as excessive ultraviolet (UV) radiation exposure. Our work shows that skin cancer risk behaviors, including sunburns, indoor tanning, and lack of protection peak at age 25. Thus, young adulthood is an important window for skin cancer risk reduction interventions. However, young adults tend to be resistant to public health recommendations because, as a group, they perceive themselves as having more immediate priorities than disease prevention, that the consequences of their current health behaviors are in the distant future, and they also tend to be experimenters and risk-takers highly influenced by peers. The principal investigator developed a web-based intervention (UV4.me) that was found to significantly decrease UV exposure and increase skin protection behaviors among young adults in a randomized controlled trial of nearly 1000 participants. The objective of this project is to investigate the reach, effectiveness, implementation, maintenance, and cost of an enhanced version of that web intervention (UV4.me2) in a large national randomized controlled trial. The ultimate goal is to improve the skin cancer protection behaviors (and potentially decrease skin cancer incidence) among a national sample of young adults at moderate to high risk of developing skin cancer. Primary Aim 1. To enhance and determine intervention reach (i.e., enrollment, representativeness). Primary Aim 2. To determine the effectiveness of the enhanced intervention. Secondary Aim 1. To determine maintenance of the UV4.m4 and UV4.me2 interventions through evaluation at 6 and 12-month follow-up. Secondary Aim 2. To determine intervention implementation by young adults. Secondary Aim 3. To determine the costs of the UV4.me and UV4.me2 interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma and Other Malignant Neoplasms of Skin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-Pamphlet
Arm Type
Active Comparator
Arm Description
A free non-interactive e-pamphlet ("Skin Cancer Prevention and Early Detection" from the American Cancer Society) will be accessible via our website.
Arm Title
Original UV4.me
Arm Type
Active Comparator
Arm Description
Participants will view the original UV4.me web intervention, which includes educational modules, personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individuals, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator. The website content will remain the same, with the exception of updating photos, statistics, and cultural references for the current year.
Arm Title
Enhanced UV4.me2
Arm Type
Experimental
Arm Description
Participants will view an enhanced version of the UV4.me website. Improvements to the website are based on user feedback from the original UV4.me trial, as well as reviews and models of effective e-Health interventions and implementation strategies.
Intervention Type
Behavioral
Intervention Name(s)
UV4.me2
Intervention Description
UV4.me2 is an enhanced version of the original UV4.me web intervention and features the many of the same educational material and interactive components. New features/strategies for reach, effectiveness, and implementation include: A mobile version of the site Incentives in the form of clickable coupons and links to free samples for sun protection products (e.g., sunscreen) Behavioral tracking and feedback, where users can set goals, track their progress, and receive tailored feedback
Intervention Type
Behavioral
Intervention Name(s)
UV4.me
Intervention Description
Original version of the UV4.me website, which offers education and tailored responses to interactive quizzes about current sun protective behaviors and barriers to engaging in sun protective behaviors.
Intervention Type
Behavioral
Intervention Name(s)
E-Pamphlet
Intervention Description
A free non-interactive e-pamphlet ("Skin Cancer Prevention and Early Detection" from the American Cancer Society). Includes information on skin cancer risk and prevention.
Primary Outcome Measure Information:
Title
Reach: eligibility by recruitment source.
Description
The number of participants who are eligible for the study by recruitment source (i.e., skin protection organizations, Google Adwords, Facebook ads, consumer research panel, word of mouth).
Time Frame
18 months
Title
Efficacy: Sun protection behaviors
Description
Skin cancer-related behavioral outcomes will initially be assessed at baseline and 3 months later. Sun protection will be measured using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
Time Frame
Change from baseline to 3 months
Title
Efficacy: UV exposure behaviors
Description
Skin cancer-related behavioral outcomes will initially be assessed at baseline and 3 months later. UV exposure will be measured using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
Time Frame
Change from baseline to 3 months
Title
Reach: enrollment by recruitment source.
Description
The number of participants who enroll in the study by recruitment source (i.e., skin protection organizations, Google Adwords, Facebook ads, consumer research panel, word of mouth).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Maintenance of skin cancer-related behavioral outcomes (sun protection)
Description
Sun protection behaviors will be assessed at 6 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
Time Frame
6 months
Title
Maintenance of skin cancer-related behavioral outcomes (sun protection)
Description
Sun protection behaviors will be assessed at 12 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.
Time Frame
12 months
Title
Maintenance of skin cancer-related behavioral outcomes (UV exposure)
Description
UV exposure will be assessed at 6 months using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
Time Frame
6 months
Title
Maintenance of skin cancer-related behavioral outcomes (UV exposure)
Description
UV exposure will be assessed at 12 months using a self-report scale assessing how many times in the past month the subject engaged in behaviors such as sunbathing and using a tanning bed/booth.
Time Frame
12 months
Title
Implementation: Web intervention use frequency
Description
How frequently participants logged into the interventions will be recorded.
Time Frame
1 month
Title
Cost of interventions
Description
Total costs of the interventions will be assessed.
Time Frame
Through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Moderate to high risk for skin cancer Exclusion Criteria: Not able to speak English Past history of skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Heckman, PhD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27819460
Citation
Heckman CJ, Handorf EA, Darlow SD, Ritterband LM, Manne SL. An online skin cancer risk-reduction intervention for young adults: Mechanisms of effects. Health Psychol. 2017 Mar;36(3):215-225. doi: 10.1037/hea0000420. Epub 2016 Nov 7.
Results Reference
background
PubMed Identifier
26810358
Citation
Heckman CJ, Darlow SD, Ritterband LM, Handorf EA, Manne SL. Efficacy of an Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Am J Prev Med. 2016 Jul;51(1):1-11. doi: 10.1016/j.amepre.2015.11.008. Epub 2016 Jan 22.
Results Reference
background
PubMed Identifier
28155000
Citation
Heckman CJ, Handorf E, Darlow SD, Yaroch AL, Raivitch S. Refinement of measures to assess psychosocial constructs associated with skin cancer risk and protective behaviors of young adults. J Behav Med. 2017 Aug;40(4):574-582. doi: 10.1007/s10865-017-9825-3. Epub 2017 Feb 2.
Results Reference
background
PubMed Identifier
34160622
Citation
Heckman CJ, Riley M, Khavjou O, Ohman-Strickland P, Manne SL, Yaroch AL, Bhurosy T, Coups EJ, Glanz K. Cost, reach, and representativeness of recruitment efforts for an online skin cancer risk reduction intervention trial for young adults. Transl Behav Med. 2021 Oct 23;11(10):1875-1884. doi: 10.1093/tbm/ibab047.
Results Reference
background

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Modifying Young Adult Skin Cancer Risk and Protective Behaviors

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