Couple-focused Intervention for Sun Protection
Primary Purpose
Skin Cancer Prevention
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sun Safe Partners Online
Generic Online Sun Safety Information intervention
Sponsored by
About this trial
This is an interventional prevention trial for Skin Cancer Prevention focused on measuring Skin Cancer
Eligibility Criteria
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)
-
Sites / Locations
- Rutgers Cancer Institute of New Jersey
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1 Sun Safe Partners Online Intervention
Generic Online Sun Safety Information intervention
Arm Description
Web-based intervention called Sun Safe Partners Online. Website developed by the study team. Participants received individual username and password to login.
Publicly online available skin cancer and sun protection information emailed to participants in 4 seperate email links.
Outcomes
Primary Outcome Measures
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).
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04549675
First Posted
September 8, 2020
Last Updated
April 7, 2021
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04549675
Brief Title
Couple-focused Intervention for Sun Protection
Official Title
Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer Prevention
Keywords
Skin Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 Sun Safe Partners Online Intervention
Arm Type
Experimental
Arm Description
Web-based intervention called Sun Safe Partners Online. Website developed by the study team. Participants received individual username and password to login.
Arm Title
Generic Online Sun Safety Information intervention
Arm Type
Active Comparator
Arm Description
Publicly online available skin cancer and sun protection information emailed to participants in 4 seperate email links.
Intervention Type
Behavioral
Intervention Name(s)
Sun Safe Partners Online
Intervention Description
Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.
Intervention Type
Behavioral
Intervention Name(s)
Generic Online Sun Safety Information intervention
Intervention Description
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 Outcome Measure Information:
Title
Sun Protection Behaviors
Description
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).
Time Frame
Baseline to 1 month FU survey
Title
Sun Exposure
Description
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
Time Frame
Baseline to 1 month FU survey
Other Pre-specified Outcome Measures:
Title
Perceived Risk of Skin cancer
Description
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)
Time Frame
Baseline to 1 month fu survey
Title
Sun Protection benefits
Description
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.
Time Frame
Baseline to 1 month fu survey
Title
Barriers to Sunscreen
Description
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.
Time Frame
Baseline to 1 month fu survey
Title
Barriers to sun protective clothing
Description
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.
Time Frame
Baseline to 1 month fu survey
Title
Self-efficacy for sun protection
Description
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).
Time Frame
Baseline to 1 month FU survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
-
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32673215
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.
Results Reference
derived
Learn more about this trial
Couple-focused Intervention for Sun Protection
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