Clinical trial NCT04549675: Couple-focused Intervention for Sun Protection
Official title: Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Cancer Prevention
Keywords: Skin Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: 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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Primary outcomes:
measure: Sun Protection Behaviors
timeFrame: Baseline to 1 month FU survey
measure: Sun Exposure
timeFrame: Baseline to 1 month FU survey
Secondary outcomes:
Other outcomes:
measure: Perceived Risk of Skin cancer
timeFrame: Baseline to 1 month fu survey
measure: Sun Protection benefits
timeFrame: Baseline to 1 month fu survey
measure: Barriers to Sunscreen
timeFrame: Baseline to 1 month fu survey
measure: Barriers to sun protective clothing
timeFrame: Baseline to 1 month fu survey
measure: Self-efficacy for sun protection
timeFrame: Baseline to 1 month FU survey
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
References:
citation: Manne S, Buller D, Devine K, Heckman C, Pagoto S, Frederick S, Mitarotondo A. Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial. J Med Internet Res. 2020 Sep 17;22(9):e18037. doi: 10.2196/18037.