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Trial record 55 of 537 for:    "Skin cancer"

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

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: NCT03313492
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
Rutgers University - Cancer Institute of New Jersey
University of Pennsylvania
ITX Corporation
RTI International
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dr. Carolyn Heckman, Ph.D, Rutgers, The State University of New Jersey

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.


Condition or disease Intervention/treatment Phase
Melanoma and Other Malignant Neoplasms of Skin Behavioral: UV4.me2 Behavioral: UV4.me Behavioral: E-Pamphlet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Modifying Young Adult Skin Cancer Risk and Protective Behaviors (UV4.me2): A Hybrid Type 2 Dissemination/Effectiveness Trial
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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.
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.

Experimental: 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.
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:

  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




Primary Outcome Measures :
  1. Reach: eligibility by recruitment source. [ Time Frame: 18 months ]
    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).

  2. Efficacy: Sun protection behaviors [ Time Frame: Change from baseline to 3 months ]
    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.

  3. Efficacy: UV exposure behaviors [ Time Frame: Change from baseline to 3 months ]
    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.

  4. Reach: enrollment by recruitment source. [ Time Frame: 18 months ]
    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 :
  1. Maintenance of skin cancer-related behavioral outcomes (sun protection) [ Time Frame: 6 months ]
    Sun protection behaviors will be assessed at 6 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.

  2. Maintenance of skin cancer-related behavioral outcomes (sun protection) [ Time Frame: 12 months ]
    Sun protection behaviors will be assessed at 12 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.

  3. Maintenance of skin cancer-related behavioral outcomes (UV exposure) [ Time Frame: 6 months ]
    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.

  4. Maintenance of skin cancer-related behavioral outcomes (UV exposure) [ Time Frame: 12 months ]
    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.

  5. Implementation: Web intervention use frequency [ Time Frame: 1 month ]
    How frequently participants logged into the interventions will be recorded.

  6. Cost of interventions [ Time Frame: Through study completion ]
    Total costs of the interventions will be assessed.



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 to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Moderate to high risk for skin cancer

Exclusion Criteria:

  • Not able to speak English
  • Past 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): NCT03313492


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rutgers University - Cancer Institute of New Jersey
University of Pennsylvania
ITX Corporation
RTI International
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carolyn Heckman, PhD Rutgers University - Cancer Institute of New Jersey
  Study Documents (Full-Text)

Documents provided by Dr. Carolyn Heckman, Ph.D, Rutgers, The State University of New Jersey:

Publications:
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Responsible Party: Dr. Carolyn Heckman, Ph.D, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03313492     History of Changes
Other Study ID Numbers: Pro2018001543
R01CA204271 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases