Modifying Young Adult Skin Cancer Risk and Protective Behaviors

NCT03313492 | Completed

• 2 other identifiers: Pro2018001543R01CA204271
• Study Type: interventional
• Target: 1,746
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma and Other Malignant Neoplasms of Skin

Outcome Measures

Primary Outcomes (4)

• 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).

  18 months

• 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.

  Change from baseline to 3 months

• 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.

  Change from baseline to 3 months

• 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).

  18 months

Secondary Outcomes (6)

• Maintenance of skin cancer-related behavioral outcomes (sun protection)

  6 months

• Maintenance of skin cancer-related behavioral outcomes (sun protection)

  12 months

• Maintenance of skin cancer-related behavioral outcomes (UV exposure)

  6 months

• Maintenance of skin cancer-related behavioral outcomes (UV exposure)

  12 months

• Implementation: Web intervention use frequency

  1 month

Study Arms (3)

E-Pamphlet

ACTIVE COMPARATOR

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

Behavioral: E-Pamphlet

Original UV4.me

ACTIVE COMPARATOR

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.

Behavioral: UV4.me

Enhanced UV4.me2

EXPERIMENTAL

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.

Behavioral: UV4.me2

Interventions

UV4.me2 BEHAVIORAL

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: 1. A mobile version of the site 2. Incentives in the form of clickable coupons and links to free samples for sun protection products (e.g., sunscreen) 3. Behavioral tracking and feedback, where users can set goals, track their progress, and receive tailored feedback

Enhanced UV4.me2

UV4.me BEHAVIORAL

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.

Original UV4.me

E-Pamphlet BEHAVIORAL

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.

E-Pamphlet

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Moderate to high risk for skin cancer

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• University of Pennsylvania: collaborator
• ITX Corporation: collaborator
• RTI International: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (5)

• 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.

  PMID: 27819460 BACKGROUND

• 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.

  PMID: 26810358 BACKGROUND

• 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.

  PMID: 28155000 BACKGROUND

• 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.

  PMID: 34160622 BACKGROUND

• Heckman CJ, Mitarotondo A, Lin Y, Khavjou O, Riley M, Manne SL, Yaroch AL, Niu Z, Glanz K. Digital Interventions to Modify Skin Cancer Risk Behaviors in a National Sample of Young Adults: Randomized Controlled Trial. J Med Internet Res. 2024 Jul 2;26:e55831. doi: 10.2196/55831.

  PMID: 38954433 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carolyn Heckman, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 18, 2017
• Study Start: September 7, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2020
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)