Modifying Young Adult Skin Cancer Risk and Protective Behaviors

Melanoma and Other Malignant Neoplasms of Skin Clinical Trial

— UV4me2  

Official title:

Modifying Young Adult Skin Cancer Risk and Protective Behaviors (UV4.me2): A Hybrid Type 2 Dissemination/Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313492
• Other study ID #: Pro2018001543
• Secondary ID: R01CA204271
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1746
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Moderate to high risk for skin cancer

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Melanoma and Other Malignant Neoplasms of Skin
• Neoplasms
• Skin Neoplasms

Intervention

Behavioral:
• UV4.me2
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
• UV4.me
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.
• E-Pamphlet
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.

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	ITX Corporation, National Cancer Institute (NCI), RTI International, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	6 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	Implementation: Web intervention use frequency	How frequently participants logged into the interventions will be recorded.	1 month
Secondary	Cost of interventions	Total costs of the interventions will be assessed.	Through study completion