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Completed

NCT Number: NCT04549675

Couple-focused Intervention for Sun Protection

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.

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Key information

Conditions

Skin Cancer Prevention Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

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Treatment and study plan

Sun Safe Partners Online

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Sun Protection Behaviors

    Time frame: Baseline to 1 month FU survey

    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).

  2. Sun Exposure

    Time frame: Baseline to 1 month FU survey

    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

Other outcomes

  1. Perceived Risk of Skin cancer

    Time frame: Baseline to 1 month fu survey

    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)

  2. Sun Protection benefits

    Time frame: Baseline to 1 month fu survey

    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.

  3. Barriers to Sunscreen

    Time frame: Baseline to 1 month fu survey

    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.

  4. Barriers to sun protective clothing

    Time frame: Baseline to 1 month fu survey

    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.

  5. Self-efficacy for sun protection

    Time frame: Baseline to 1 month FU survey

    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).

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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