NCT04549675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

September 8, 2020

Last Update Submit

April 7, 2021

Conditions

Keywords

Skin Cancer

Outcome Measures

Primary Outcomes (2)

  • 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).

    Baseline to 1 month FU survey

  • 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

    Baseline to 1 month FU survey

Other Outcomes (5)

  • Perceived Risk of Skin cancer

    Baseline to 1 month fu survey

  • Sun Protection benefits

    Baseline to 1 month fu survey

  • Barriers to Sunscreen

    Baseline to 1 month fu survey

  • +2 more other outcomes

Study Arms (2)

Arm 1 Sun Safe Partners Online Intervention

EXPERIMENTAL

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

Generic Online Sun Safety Information intervention

ACTIVE COMPARATOR

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

Behavioral: Generic Online Sun Safety Information intervention

Interventions

Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.

Arm 1 Sun Safe Partners Online 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.

Generic Online Sun Safety Information intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Partner 1 and spouse/partner have a personal history of skin cancer (non-melanoma or melanoma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Behavioral Sciences Professor, Dept of Medicine, Robert Wood Johnson Medical School

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 16, 2020

Study Start

May 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations