NCT03132012

Brief Summary

This is a pilot randomized controlled trial of an Internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-Hispanic white females ages 20-30.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

March 20, 2017

Last Update Submit

June 25, 2018

Conditions

Skin Neoplasms

Outcome Measures

Primary Outcomes (6)

  • Intention to indoor tan in next year

    Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).

    Baseline

  • Intention to indoor tan in next year

    Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).

    12 Weeks First Follow-up

  • Intention to indoor tan in next year

    Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan) to 7 (definitely do intend to indoor tan).

    24 Weeks Second Follow-up

  • Number of indoor tanning sessions in the previous 3 months

    Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.

    12 weeks preceding baseline

  • Number of indoor tanning sessions in the previous 3 months

    Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.

    baseline to 12 Weeks (First Follow-up)

  • Number of indoor tanning sessions in the previous 3 months

    Self-report measure of number of times indoor tanned, reported retrospectively for the preceding 3 months.

    From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)

Secondary Outcomes (6)

  • Intention to sunbathe outdoors in the next year

    Baseline

  • Intention to sunbathe outdoors in the next year

    12 weeks First Follow-up

  • Intention to sunbathe outdoors in the next year

    24 weeks Second Follow-up

  • Number of outdoor sunbathing sessions in the previous 3 months

    12 weeks preceding baseline

  • Number of outdoor sunbathing sessions in the previous 3 months

    baseline to 12 Weeks (First Follow-up)

  • +1 more secondary outcomes

Study Arms (2)

Indoor tanning intervention

EXPERIMENTAL

Web-based intervention modules to discourage tanning.

Behavioral: Indoor tanning intervention

standard of care control

ACTIVE COMPARATOR

General information regarding UV protection measures through an online Qualtrics interface. Content will mirror information provided in brochures typically available in a dermatology office or through skin cancer prevention websites.

Behavioral: Standard of care control

Interventions

Indoor tanning interventionBEHAVIORAL

6 Web-based modules that focus on preventing skin cancer through sun protection and indoor tanning reduction using the Theory of Planned Behavior and Prospect Theory

Indoor tanning intervention
Standard of care controlBEHAVIORAL

One website with content similar to those available in dermatology offices on skin cancer prevention

standard of care control

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Tanned indoors in past 12 months
  • Able to communicate well in English
  • Reliable Internet access

You may not qualify if:

  • History of skin cancer (self-report)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Public Health

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 27, 2017

Study Start

May 22, 2017

Primary Completion

February 27, 2018

Study Completion

February 27, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

US(1)