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Completed

NCT Number: NCT03028948

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-Based Intervention

Other

Access ITW

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Number of SSEs Performed

    Time frame: At 8, 24 and 48 weeks

    Total number of SSEs performed (regardless of their thoroughness)

  4. 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

  5. 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

  6. 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

  7. Number of Sunburns

    Time frame: At 8, 24 and 48 weeks

    Total number of sunburns received

  8. Wearing Long Pants

    Time frame: At 8, 24 and 48 weeks

    Frequency (from 1 = never to 5 = always) of wearing long pants

  9. Wearing Sunglasses

    Time frame: At 8, 24 and 48 weeks

    Frequency (from 1 = never to 5 = always) of wearing sunglasses

  10. 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

  11. 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.

  12. 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.

  13. 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.

Other outcomes

  1. Distress About Melanoma

    Time frame: At 8, 24 and 48 weeks

    Level of distress (from 1 = not at all distressed to 10 = extremely distressed)

  2. Worry About Melanoma Recurrence

    Time frame: At 8, 24 and 48 weeks

    Mean rating of four questions regarding worry about melanoma recurrence

  3. Perceived Risk of Melanoma Recurrence

    Time frame: At 8, 24 and 48 weeks

    Mean rating of four questions regarding perceived risk of melanoma recurrence

  4. Biopsies Conducted

    Time frame: At 48 weeks

    Number of biopsies conducted

  5. Indoor Tanning

    Time frame: At 48 weeks

    Number of times indoor tanned in the past year

  6. Diagnosis of New or Recurrent Skin Cancers

    Time frame: At 48 weeks

    Whether a new or recurrent skin cancer was diagnosed

  7. 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.

  8. 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

  9. 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.

  10. 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).

  11. 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Virginia

Registry information

Official study title

Internet Intervention for Sun Protection and Skin Self-check Behaviors

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2017
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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