Couple-focused Intervention for Sun Protection

Skin Cancer Prevention Clinical Trial

Official title:

Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549675
• Other study ID #: Pro20150001694
• Secondary ID: 131503
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Both partners age 18-75 years or 19-75 in Nebraska and Alabama given the age of majority in those states;

2. Married or co-habiting with a significant other for at least one year;

3. Partner 1 willing to to provide contact information for their spouse;

4. 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.

5. 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)

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Related Conditions & MeSH terms

• Skin Cancer Prevention
• Skin Neoplasms

Intervention

Behavioral:
• Sun Safe Partners Online
Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.
• Generic Online Sun Safety Information intervention
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.

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived Risk of Skin cancer	Three items assessed the perceived risk of skin cancer (sample item: "If I don't protect myself from the sun, I would feel vulnerable to getting skin cancer in my lifetime"). Items were rated on Likert-type response scales, ranging from 1 (strongly disagree) to 5 (strongly agree)	Baseline to 1 month fu survey
Other	Sun Protection benefits	Nine item scale assessessing sun protection benefits (sample item: "Regularly wearing sunscreen when in the sun would reduce my chances of getting skin cancer"). Scale utilizes likert items on 1 (strongly disagree) to 5 (strongly agree) scale.	Baseline to 1 month fu survey
Other	Barriers to Sunscreen	9 item scale measuring sunscreen barriers (sample item: "For me, using sunscreen when I am outside on a warm sunny day is not part of my daily routine"). Scale utilizes likert items on 1 (strongly disagree) to 5 (strongly agree) scale.	Baseline to 1 month fu survey
Other	Barriers to sun protective clothing	7 item scale measuring sunscreen barriers (sample item: ""For me, using sunscreen when I am outside on a warm sunny day is not part of my daily routine""). Scale utilizes likert items on 1 (strongly disagree) to 5 (strongly agree) scale.	Baseline to 1 month fu survey
Other	Self-efficacy for sun protection	9 item scale assessing confidence in performing sun protection behaviors. Sample item: "Are participants confident that they can use sunscreen on every part of their body that is not covered by clothing?" Scale utilizes likert items from 1 (not at all confident) to 5 (very confident).	Baseline to 1 month FU survey
Primary	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
Primary	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