Couple-focused Intervention for Sun Protection

Study Overview
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Brief Summary
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The goal of this pilot study is to develop and test a couple-based intervention to increase sun protection practices. First, the investigators will develop the intervention website, Sun Safe Partners online. Next, the investigators will gather feedback and preferences for content in a small sample of couples who do not regularly engage in sun protection practices. The investigators will also gather preliminary information regarding the impact of the couple-based intervention.

Detailed Description
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Aim 1: To develop and evaluate the feasibility of a couple-based sun protection intervention. Aim 2: To examine the impact of the couple-based sun protection intervention on sun protection practices, individual attitudes, relationship perspective on sun protection, and couples' discussion with each other and their supportive communications about sun protection. Aim 3: To develop and refine a SunSafe Partners online intervention. This process includes refining existing intervention content drawn from the first phase of this pilot research as well as formative and usability studies to obtain user-generated feedback on additional content and the approach. Aim 4: To gather pilot data on participation in and evaluations of the Sun Safe partner's intervention from Aim 3. Arm 1: Web-based intervention called Sun Safe Partners Online Arm 2: Generic Online Sun Safety Information intervention- 4 links emailed to participants

Official Title
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Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial

Conditions
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Skin Cancer Prevention

Intervention / Treatment
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* Behavioral: Sun Safe Partners Online
* Behavioral: Generic Online Sun Safety Information intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both partners age 18-75 years or 19-75 in Nebraska and Alabama given the age of majority in those states; Married or co-habiting with a significant other for at least one year; Partner 1 willing to to provide contact information for their spouse; Partner 1 and spouse respond with never, rarely, sometimes, or often to question  When outdoors in warm weather, how often do participants protect their skin (by staying in the shade or covering your body with protective clothes or 30+ SPF sunscreen)? Those who respond with always to this question will be excluded. Partner 1 and spouse have an email account and internet access. Exclusion Criteria: Partner 1 and spouse/partner have a personal history of skin cancer (non-melanoma or melanoma) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Sun Safe Partners Online Intervention<br>Web-based intervention called Sun Safe Partners Online. Website developed by the study team. Participants received individual username and password to login. | Behavioral: Sun Safe Partners Online<br>* Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.<br>|
| Active Comparator: Generic Online Sun Safety Information intervention<br>Publicly online available skin cancer and sun protection information emailed to participants in 4 seperate email links. | Behavioral: Generic Online Sun Safety Information intervention<br>* 4 links to sent to participants from (1) The Skin Cancer Foundation's Skin Cancer Prevention guidelines, (2) the Centers for Disease Control and Prevention's information on risk factors for skin cancer, (3) the American Academy of Dermatology's information on how to select an appropriate sunscreen, and (4) The Skin Cancer Foundation's information on sun protective clothing. Participants were emailed a link to one of the resources each week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sun Protection Behaviors | Impact of Sun Safe Partners Online vs Generic Online intervention on Sun protection behavior measures. The Sun Habits survey asked participants to rate their frequency of 5 sun protection behaviors (sunscreen, hat, shirt with sleeves, long pants, and sunglasses) on warm sunny days (1=never to 5=always). | Baseline to 1 month FU survey | 
| Sun Exposure | Sun Exposure: The Sun Habits Survey asked participants to rate the duration of outdoor time during peak hours on weekends and weekdays over the past summer months, 1=30 min or less, and 8=more than 6 hours. Self-report measures of time outdoors have s | Baseline to 1 month FU survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Cancer