Stage 0 Skin MelanomaNCT03028948
Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma
A study testing Internet-Based Intervention, Questionnaire Administration and Survey Administration in people with Stage 0 Skin Melanoma and Stage I Skin Melanoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 0 Skin Melanoma, Stage I Skin Melanoma, Stage IA Skin Melanoma
- What is being tested?
- Internet-Based Intervention, Questionnaire Administration and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2017to 29 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia
Charlottesville, Virginia, 22904
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Internet Intervention for Sun Protection and Skin Self-check Behaviors
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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
- Stage 0 Skin Melanoma, Stage I Skin Melanoma, Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage II Skin Melanoma, Stage IIA Skin Melanoma
- Being tested
- Internet-Based Intervention, Questionnaire Administration, Survey Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Access ITW
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (13)
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months
Measured: At 24 weeks
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
Measured: 48 weeks
Number of SSEs Performed
Total number of SSEs performed (regardless of their thoroughness)
Measured: At 8, 24 and 48 weeks
Number of Body Areas Examined
Total number of body areas examined during the most recent SSE in the last 2 months
Measured: At 8, 24 and 48 weeks
Use of Tools to Facilitate SSE
Use of a mirror, having someone else help, or using a body mole map during the most recent SSE
Measured: At 8, 24 and 48 weeks
Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index
Frequency (from 1 = never to 5 = always) of wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade
Measured: At 8, 24 and 48 weeks
Number of Sunburns
Total number of sunburns received
Measured: At 8, 24 and 48 weeks
Wearing Long Pants
Frequency (from 1 = never to 5 = always) of wearing long pants
Measured: At 8, 24 and 48 weeks
Wearing Sunglasses
Frequency (from 1 = never to 5 = always) of wearing sunglasses
Measured: At 8, 24 and 48 weeks
Sunbathing
Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
Measured: At 8, 24 and 48 weeks
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.
Measured: Baseline
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.
Measured: At 8 weeks
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.
Measured: At 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start13 Jan 2017
- Primary completion29 Aug 2020
- Study completion29 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage 0 Skin MelanomaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Virginia
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers, The State University of New Jersey
- Investigators
- Elliot Coups, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028948
- Sponsor's protocol ID
- 131403
- Other IDs
- NCI-2017-00084, Pro2014000095, Pro2014000095, R01CA171666
- Status last verified
- Dec 2025
- First submitted
- 19 Jan 2017
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31255801
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Intervention for Sun Protection and Skin Self-check Behaviors
- ClinicalTrials.gov ID
- NCT03028948
- Acronym / sponsor ID
- 131403
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Virginia
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 29 Aug 2020 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 9 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ITW) | Experimental | Other: Internet-Based Intervention, Other: Questionnaire Administration, Other: Survey AdministrationPatients 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. |
| Arm II (usual care) | Active comparator | Other: Questionnaire Administration, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionAccess ITW | Other | Arm I (ITW) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (ITW), Arm II (usual care) |
| Survey AdministrationAncillary studies | Other | Arm I (ITW), Arm II (usual care) |
Primary outcome
Sun Protection Behavior Index
Time frame: At 24 weeks
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.
Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months
Time frame: 8 weeks
Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.
13 secondary outcomes
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
Time frame: At 24 weeks
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
Time frame: 48 weeks
Number of SSEs Performed
Time frame: At 8, 24 and 48 weeks
Number of Body Areas Examined
Time frame: At 8, 24 and 48 weeks
Use of Tools to Facilitate SSE
Time frame: At 8, 24 and 48 weeks
Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index
Time frame: At 8, 24 and 48 weeks
Number of Sunburns
Time frame: At 8, 24 and 48 weeks
Wearing Long Pants
Time frame: At 8, 24 and 48 weeks
Wearing Sunglasses
Time frame: At 8, 24 and 48 weeks
Sunbathing
Time frame: At 8, 24 and 48 weeks
Sun Protection Behavior Index
Time frame: Baseline
Sun Protection Behavior Index
Time frame: At 8 weeks
Sun Protection Behavior Index
Time frame: At 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31255801Coups 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Coups principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention, Questionnaire Administration and Survey Administration in people with Stage 0 Skin Melanoma and Stage I Skin Melanoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sun Protection Behavior Index (time frame: At 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03028948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.