Couple-focused Intervention for Sun Protection

April 7, 2021 updated by: Sharon Manne, PhD, Rutgers, The State University of New Jersey

Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1 Sun Safe Partners Online Intervention
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
Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.
ACTIVE_COMPARATOR: Generic Online Sun Safety Information intervention
Publicly online available skin cancer and sun protection information emailed to participants in 4 seperate email links.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline to 1 month FU survey
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
Baseline to 1 month FU survey

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline to 1 month fu survey
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.
Baseline to 1 month fu survey
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.
Baseline to 1 month fu survey
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.
Baseline to 1 month fu survey
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).
Baseline to 1 month FU survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ACTUAL)

November 30, 2019

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro20150001694
  • 131503 (OTHER: Rutgers Cancer Institute of New Jersey)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Cancer Prevention

Clinical Trials on Sun Safe Partners Online

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe