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

February 6, 2023 updated by: Sharon Manne, PhD, Rutgers, The State University of New Jersey

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.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

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.

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Ancillary studies
Ancillary studies
Access ITW
ACTIVE_COMPARATOR: 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.
Ancillary studies
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 24 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
Time Frame: At 24 weeks
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months
At 24 weeks
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
Time Frame: 48 weeks
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
48 weeks
Number of SSEs Performed
Time Frame: At 8, 24 and 48 weeks
Total number of SSEs performed (regardless of their thoroughness)
At 8, 24 and 48 weeks
Number of Body Areas Examined
Time Frame: At 8, 24 and 48 weeks
Total number of body areas examined during the most recent SSE in the last 2 months
At 8, 24 and 48 weeks
Use of Tools to Facilitate SSE
Time Frame: At 8, 24 and 48 weeks
Use of a mirror, having someone else help, or using a body mole map during the most recent SSE
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
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
At 8, 24 and 48 weeks
Number of Sunburns
Time Frame: At 8, 24 and 48 weeks
Total number of sunburns received
At 8, 24 and 48 weeks
Wearing Long Pants
Time Frame: At 8, 24 and 48 weeks
Frequency (from 1 = never to 5 = always) of wearing long pants
At 8, 24 and 48 weeks
Wearing Sunglasses
Time Frame: At 8, 24 and 48 weeks
Frequency (from 1 = never to 5 = always) of wearing sunglasses
At 8, 24 and 48 weeks
Sunbathing
Time Frame: At 8, 24 and 48 weeks
Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
At 8, 24 and 48 weeks
Sun Protection Behavior Index
Time Frame: Baseline
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.
Baseline
Sun Protection Behavior Index
Time Frame: At 8 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.
At 8 weeks
Sun Protection Behavior Index
Time Frame: At 48 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.
At 48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress About Melanoma
Time Frame: At 8, 24 and 48 weeks
Level of distress (from 1 = not at all distressed to 10 = extremely distressed)
At 8, 24 and 48 weeks
Worry About Melanoma Recurrence
Time Frame: At 8, 24 and 48 weeks
Mean rating of four questions regarding worry about melanoma recurrence
At 8, 24 and 48 weeks
Perceived Risk of Melanoma Recurrence
Time Frame: At 8, 24 and 48 weeks
Mean rating of four questions regarding perceived risk of melanoma recurrence
At 8, 24 and 48 weeks
Biopsies Conducted
Time Frame: At 48 weeks
Number of biopsies conducted
At 48 weeks
Indoor Tanning
Time Frame: At 48 weeks
Number of times indoor tanned in the past year
At 48 weeks
Diagnosis of New or Recurrent Skin Cancers
Time Frame: At 48 weeks
Whether a new or recurrent skin cancer was diagnosed
At 48 weeks
Indicators of Study Feasibility
Time Frame: At 48 weeks
Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.
At 48 weeks
Visits to Healthcare Provider Related to Skin Surveillance
Time Frame: At 8, 24 and 48 weeks
Receipt of a physician skin examination and the reason for the visit
At 8, 24 and 48 weeks
Impact and Effectiveness of the Interactive Tailored Website
Time Frame: At 8 weeks
Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.
At 8 weeks
Usage of the Interactive Tailored Website
Time Frame: At 8, 24 and 48 weeks
Number of visits to the website, the number of monthly skin self-checks completed, the number of updates to the sun-safe action plan, and starting/completing the remaining sections of the website (Introduction; Getting Ready to Do a Skin Self-Check; Practice Sun-Safe Behaviors).
At 8, 24 and 48 weeks
Evaluation and Utility of the Interactive Tailored Website
Time Frame: At 8 weeks
Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.
At 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elliot Coups, Rutgers Cancer Institute of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2017

Primary Completion (ACTUAL)

July 12, 2019

Study Completion (ACTUAL)

July 12, 2019

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 131403
  • NCI-2017-00084 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • Pro2014000095 (OTHER: Rutgers Cancer Institute of New Jersey)
  • R01CA171666 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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