Couple-focused Intervention for Sun Protection

NCT ID: NCT04549675

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-11-30

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

Conditions

Skin Cancer Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sun Safe Partners Online

Intervention Type: 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

Publicly online available skin cancer and sun protection information emailed to participants in 4 seperate email links.

Group Type: ACTIVE_COMPARATOR

Generic Online Sun Safety Information intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Sharon Manne, PhD

Chief, Behavioral Sciences Professor, Dept of Medicine, Robert Wood Johnson Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32673215 (View on PubMed)

Other Identifiers

131503

Identifier Type: OTHER

Identifier Source: secondary_id

Pro20150001694

Identifier Type: -

Identifier Source: org_study_id