Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma
NCT ID: NCT03028948
Last Updated: 2026-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
485 participants
INTERVENTIONAL
2017-01-13
2020-08-29
Brief Summary
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Detailed Description
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I. To evaluate the impact of the interactive tailored website (ITW) versus usual care on skin self-examination (SSE) and sun protection behaviors among individuals diagnosed with melanoma.
SECONDARY OBJECTIVES:
I. To examine mediators of the impact of the intervention. The effects of the intervention on SSE and sun protection behaviors will be mediated by melanoma knowledge, self-efficacy for SSE and sun protection behaviors, perceived benefits of SSE and sun protection behaviors, perceived barriers to SSE and sun protection behaviors, and perceived controllability of melanoma.
TERTIARY OBJECTIVES:
I. To examine moderators of the impact of the intervention. To evaluate whether ITW effects are moderated by the following factors: time since diagnosis, disease stage, age, sex, income, education, Internet experience, distress about melanoma, worry about recurrence, and evaluation and usage of the ITW.
OUTLINE:
Phase I: Patients review draft website content materials in a semi-structured format and provide feedback via open- and closed-ended questions for the development, testing, and finalization of ITW.
Phase II: Patients are randomized into 1 of 2 arms.
ARM I: Patients access ITW and complete each module over 30-40 minutes.
ARM II: Patients receive usual care and are then offered ITW.
All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (ITW)
Patients access ITW and complete each module over 30-40 minutes. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
Internet-Based Intervention
Access ITW
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Arm II (usual care)
Patients receive usual care and are then offered ITW. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Internet-Based Intervention
Access ITW
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* Phase I: From 3-36 months post-surgical treatment
* Phase I: Access to the internet
* Phase I: Able to speak and read English
* Phase I: Able to provide informed consent
* Phase II: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
* Phase II: From 3-24 months post-surgical treatment
* Phase II: Not adherent to thorough SSE (i.e., did not check every area of the body at least once during the past 2 months)
* Phase II: Not adherent to sun protection recommendations (i.e., mean score \< 4 \[which corresponds to "often"\] on a 5-point scale \[from 1 = "never" to 5 = "always"\] that assesses the frequency of engaging in four sun protection behaviors)
* Phase II: Access to a computer connected to the internet
* Phase II: Able to speak and read English
* Phase II: Able to provide informed consent
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Virginia
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Sharon Manne, PhD
Professor and Associate Director of Population Science
Principal Investigators
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Elliot Coups
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Coups EJ, Manne SL, Ohman Strickland P, Hilgart M, Goydos JS, Heckman CJ, Chamorro P, Rao BK, Davis M, Smith FO, Thorndike FP, Ritterband LM. Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics. Contemp Clin Trials. 2019 Aug;83:117-127. doi: 10.1016/j.cct.2019.06.014. Epub 2019 Jun 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-00084
Identifier Type: REGISTRY
Identifier Source: secondary_id
Pro2014000095
Identifier Type: OTHER
Identifier Source: secondary_id
Pro2014000095
Identifier Type: OTHER
Identifier Source: secondary_id
131403
Identifier Type: -
Identifier Source: org_study_id
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