- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028948
Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma
Internet Intervention for Sun Protection and Skin Self-check Behaviors
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey
-
-
Virginia
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Charlottesville, Virginia, United States, 22904
- University of Virginia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
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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.
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At 24 weeks
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Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months
Time Frame: 8 weeks
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Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.
|
8 weeks
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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
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Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months
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At 24 weeks
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Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
Time Frame: 48 weeks
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Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
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48 weeks
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Number of SSEs Performed
Time Frame: At 8, 24 and 48 weeks
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Total number of SSEs performed (regardless of their thoroughness)
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At 8, 24 and 48 weeks
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Number of Body Areas Examined
Time Frame: At 8, 24 and 48 weeks
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Total number of body areas examined during the most recent SSE in the last 2 months
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At 8, 24 and 48 weeks
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Use of Tools to Facilitate SSE
Time Frame: At 8, 24 and 48 weeks
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Use of a mirror, having someone else help, or using a body mole map during the most recent SSE
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At 8, 24 and 48 weeks
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Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index
Time Frame: At 8, 24 and 48 weeks
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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
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At 8, 24 and 48 weeks
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Number of Sunburns
Time Frame: At 8, 24 and 48 weeks
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Total number of sunburns received
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At 8, 24 and 48 weeks
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Wearing Long Pants
Time Frame: At 8, 24 and 48 weeks
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Frequency (from 1 = never to 5 = always) of wearing long pants
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At 8, 24 and 48 weeks
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Wearing Sunglasses
Time Frame: At 8, 24 and 48 weeks
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Frequency (from 1 = never to 5 = always) of wearing sunglasses
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At 8, 24 and 48 weeks
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Sunbathing
Time Frame: At 8, 24 and 48 weeks
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Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
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At 8, 24 and 48 weeks
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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
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distress About Melanoma
Time Frame: At 8, 24 and 48 weeks
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Level of distress (from 1 = not at all distressed to 10 = extremely distressed)
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At 8, 24 and 48 weeks
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Worry About Melanoma Recurrence
Time Frame: At 8, 24 and 48 weeks
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Mean rating of four questions regarding worry about melanoma recurrence
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At 8, 24 and 48 weeks
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Perceived Risk of Melanoma Recurrence
Time Frame: At 8, 24 and 48 weeks
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Mean rating of four questions regarding perceived risk of melanoma recurrence
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At 8, 24 and 48 weeks
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Biopsies Conducted
Time Frame: At 48 weeks
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Number of biopsies conducted
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At 48 weeks
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Indoor Tanning
Time Frame: At 48 weeks
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Number of times indoor tanned in the past year
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At 48 weeks
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Diagnosis of New or Recurrent Skin Cancers
Time Frame: At 48 weeks
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Whether a new or recurrent skin cancer was diagnosed
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At 48 weeks
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Indicators of Study Feasibility
Time Frame: At 48 weeks
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Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.
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At 48 weeks
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Visits to Healthcare Provider Related to Skin Surveillance
Time Frame: At 8, 24 and 48 weeks
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Receipt of a physician skin examination and the reason for the visit
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At 8, 24 and 48 weeks
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Impact and Effectiveness of the Interactive Tailored Website
Time Frame: At 8 weeks
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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.
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At 8 weeks
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Usage of the Interactive Tailored Website
Time Frame: At 8, 24 and 48 weeks
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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).
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At 8, 24 and 48 weeks
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Evaluation and Utility of the Interactive Tailored Website
Time Frame: At 8 weeks
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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.
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At 8 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Elliot Coups, Rutgers Cancer Institute of New Jersey
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
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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