Modifying Young Adult Skin Cancer Risk and Protective Behaviors

NCT ID: NCT03313492

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1746 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma and Other Malignant Neoplasms of Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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E-Pamphlet

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

Group Type ACTIVE_COMPARATOR

E-Pamphlet

Intervention Type 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.

Original UV4.me

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.

Group Type ACTIVE_COMPARATOR

UV4.me

Intervention Type 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.

Enhanced UV4.me2

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.

Group Type EXPERIMENTAL

UV4.me2

Intervention Type 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

Interventions

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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:

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Moderate to high risk for skin cancer

Exclusion Criteria

* Not able to speak English
* Past history of skin cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

ITX Corporation

UNKNOWN

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Dr. Carolyn Heckman, Ph.D

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn Heckman, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27819460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26810358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28155000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34160622 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38954433 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA204271

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2018001543

Identifier Type: -

Identifier Source: org_study_id

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