Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma

NCT03028948 | Completed Results

• 4 other identifiers: 131403NCI-2017-00084Pro2014000095R01CA171666
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial studies how well an interactive tailored website works in promoting sun protection and skin self-check behaviors in patients with stage 0-III melanoma. An internet-based program may help individuals to perform skin self-checks and engage in sun protection behaviors.

Conditions

Stage 0 Skin Melanoma; Stage I Skin Melanoma; Stage IA Skin Melanoma; Stage IB Skin Melanoma; Stage II Skin Melanoma; Stage IIA Skin Melanoma; Stage IIB Skin Melanoma; Stage IIC Skin Melanoma; Stage III Skin Melanoma; Stage IIIA Skin Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma

Outcome Measures

Primary Outcomes (2)

• Sun Protection Behavior Index

  Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.

  At 24 weeks

• Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months

  Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.

  8 weeks

Secondary Outcomes (13)

• Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months

  At 24 weeks

• Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months

  48 weeks

• Number of SSEs Performed

  At 8, 24 and 48 weeks

• Number of Body Areas Examined

  At 8, 24 and 48 weeks

• Use of Tools to Facilitate SSE

  At 8, 24 and 48 weeks

Other Outcomes (11)

• Distress About Melanoma

  At 8, 24 and 48 weeks

• Worry About Melanoma Recurrence

  At 8, 24 and 48 weeks

• Perceived Risk of Melanoma Recurrence

  At 8, 24 and 48 weeks

Study Arms (2)

Arm I (ITW)

EXPERIMENTAL

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.

Other: Internet-Based Intervention; Other: Questionnaire Administration; Other: Survey Administration

Arm II (usual care)

ACTIVE COMPARATOR

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.

Other: Questionnaire Administration; Other: Survey Administration

Interventions

Internet-Based Intervention OTHER

Access ITW

Arm I (ITW)

Questionnaire Administration OTHER

Ancillary studies

Arm I (ITW); Arm II (usual care)

Survey Administration OTHER

Ancillary studies

Arm I (ITW); Arm II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• University of Virginia: collaborator

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• 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.

  PMID: 31255801 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Findings may be less generalizable to those with low sun protection behavior. We recruited from one state so participant pool may not represent the US population. SSE and sun protection were assessed using self-report. Sun content was in the last core and reviewed by fewer participants. Sample was primarily non-Hispanic white.

Results Point of Contact

• Title: Dr. Sharon Manne
• Organization: Rutgers Cancer Institute of New Jersey

mannesl@cinj.rutgers.edu

7322356759

Study Officials

• Elliot Coups

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Director of Population Science

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: January 13, 2017
• Primary Completion: August 29, 2020
• Study Completion: August 29, 2020
• Last Updated: January 14, 2026
• Results First Posted: February 9, 2023

Record last verified: 2025-12

Locations

US (2)