Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-02-02 @ 7:18 AM
Study NCT ID:
NCT03313492
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modifying Young Adult Skin Cancer Risk and Protective Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-26', 'releaseDate': '2024-11-01'}, {'resetDate': '2025-05-05', 'releaseDate': '2025-04-17'}, {'resetDate': '2025-08-07', 'releaseDate': '2025-07-22'}], 'estimatedResultsFirstSubmitDate': '2024-11-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-20', 'size': 296284, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-09-27T11:24', 'hasProtocol': True}, {'date': '2018-08-02', 'size': 1522500, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-17T14:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1746}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach: eligibility by recruitment source.', 'timeFrame': '18 months', '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).'}, {'measure': 'Efficacy: Sun protection behaviors', 'timeFrame': 'Change from baseline to 3 months', '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.'}, {'measure': 'Efficacy: UV exposure behaviors', 'timeFrame': 'Change from baseline to 3 months', '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.'}, {'measure': 'Reach: enrollment by recruitment source.', 'timeFrame': '18 months', '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).'}], 'secondaryOutcomes': [{'measure': 'Maintenance of skin cancer-related behavioral outcomes (sun protection)', 'timeFrame': '6 months', 'description': 'Sun protection behaviors will be assessed at 6 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.'}, {'measure': 'Maintenance of skin cancer-related behavioral outcomes (sun protection)', 'timeFrame': '12 months', 'description': 'Sun protection behaviors will be assessed at 12 months using a self-report scale assessing behaviors such as sunscreen use and shade seeking.'}, {'measure': 'Maintenance of skin cancer-related behavioral outcomes (UV exposure)', 'timeFrame': '6 months', '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.'}, {'measure': 'Maintenance of skin cancer-related behavioral outcomes (UV exposure)', 'timeFrame': '12 months', '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.'}, {'measure': 'Implementation: Web intervention use frequency', 'timeFrame': '1 month', 'description': 'How frequently participants logged into the interventions will be recorded.'}, {'measure': 'Cost of interventions', 'timeFrame': 'Through study completion', 'description': 'Total costs of the interventions will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma and Other Malignant Neoplasms of Skin']}, 'referencesModule': {'references': [{'pmid': '27819460', 'type': 'BACKGROUND', '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.'}, {'pmid': '26810358', 'type': 'BACKGROUND', '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.'}, {'pmid': '28155000', 'type': 'BACKGROUND', '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.'}, {'pmid': '34160622', 'type': 'BACKGROUND', '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.'}, {'pmid': '38954433', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nPrimary Aim 1. To enhance and determine intervention reach (i.e., enrollment, representativeness).\n\nPrimary Aim 2. To determine the effectiveness of the enhanced intervention.\n\nSecondary Aim 1. To determine maintenance of the UV4.m4 and UV4.me2 interventions through evaluation at 6 and 12-month follow-up.\n\nSecondary Aim 2. To determine intervention implementation by young adults.\n\nSecondary Aim 3. To determine the costs of the UV4.me and UV4.me2 interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to high risk for skin cancer\n\nExclusion Criteria:\n\n* Not able to speak English\n* Past history of skin cancer'}, 'identificationModule': {'nctId': 'NCT03313492', 'acronym': 'UV4me2', 'briefTitle': 'Modifying Young Adult Skin Cancer Risk and Protective Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Modifying Young Adult Skin Cancer Risk and Protective Behaviors (UV4.me2): A Hybrid Type 2 Dissemination/Effectiveness Trial', 'orgStudyIdInfo': {'id': 'Pro2018001543'}, 'secondaryIdInfos': [{'id': 'R01CA204271', 'link': 'https://reporter.nih.gov/quickSearch/R01CA204271', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'E-Pamphlet', 'description': 'A free non-interactive e-pamphlet ("Skin Cancer Prevention and Early Detection" from the American Cancer Society) will be accessible via our website.', 'interventionNames': ['Behavioral: E-Pamphlet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Original UV4.me', '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.', 'interventionNames': ['Behavioral: UV4.me']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced UV4.me2', '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.', 'interventionNames': ['Behavioral: UV4.me2']}], 'interventions': [{'name': 'UV4.me2', 'type': 'BEHAVIORAL', '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:\n\n1. A mobile version of the site\n2. Incentives in the form of clickable coupons and links to free samples for sun protection products (e.g., sunscreen)\n3. Behavioral tracking and feedback, where users can set goals, track their progress, and receive tailored feedback', 'armGroupLabels': ['Enhanced UV4.me2']}, {'name': 'UV4.me', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Original UV4.me']}, {'name': 'E-Pamphlet', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['E-Pamphlet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Carolyn Heckman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'ITX Corporation', 'class': 'UNKNOWN'}, {'name': 'RTI International', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Carolyn Heckman, Ph.D', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-01', 'type': 'RELEASE'}, {'date': '2024-11-26', 'type': 'RESET'}, {'date': '2025-04-17', 'type': 'RELEASE'}, {'date': '2025-05-05', 'type': 'RESET'}, {'date': '2025-07-22', 'type': 'RELEASE'}, {'date': '2025-08-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr. Carolyn Heckman, Ph.D, Associate Professor, Rutgers, The State University of New Jersey'}}}}