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

Study Overview
=================
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.

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.

Official Title
-----------------
Internet Intervention for Sun Protection and Skin Self-check 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

Intervention / Treatment
-----------------
* Other: Internet-Based Intervention
* Other: Questionnaire Administration
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (ITW)<br>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<br>* Access ITW<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (usual care)<br>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<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 48 weeks | 
| Number of SSEs Performed | Total number of SSEs performed (regardless of their thoroughness) | 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 | 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 | 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 | At 8, 24 and 48 weeks | 
| Number of Sunburns | Total number of sunburns received | At 8, 24 and 48 weeks | 
| Wearing Long Pants | Frequency (from 1 = never to 5 = always) of wearing long pants | At 8, 24 and 48 weeks | 
| Wearing Sunglasses | Frequency (from 1 = never to 5 = always) of wearing sunglasses | 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 | 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. | 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. | 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. | At 48 weeks |