Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing

November 13, 2018 updated by: Karen Glanz, University of Pennsylvania
Phase 3b of the research will be a laboratory experiment that uses an experimental and analytic design that is parallel to that used in Phase 3a, the online experiment. The primary objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral intentions and UV-related behavioral choices post-exposure. Including time for preparation, viewing, and removal of the monitoring equipment, the message viewing session will take about 45 minutes per session.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3595

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • CIRNA Lab

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-49 year old non-Hispanic white (NHW) adults
  • OR 18-25 year old NHW females who have tanned indoors in the past 12 months

Exclusion Criteria:

-

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Outdoor Sun Exposure Behavior

A convenience sample of white, English-speaking adults ages 18 to 49 will be recruited via online advertisements in Philadelphia and the surrounding region (within a 30 mile radius). The investigators will recruit 120 adults to test outdoor UV exposure messages. The investigators will quota sample to ensure representation across age and gender groups.

The inclusion criteria are that adults must be white, must be between 18-49 years old and must speak English.
Behavioral: Outdoor Sun Behavior
Participants will provide informed consent and complete a short background questionnaire about usual sun exposure and protection behaviors and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a computer monitor, keyboard and mouse setup. Each participant will view messages with different emotional appeals related to outdoor sun exposure (seeking shade, covering up, using sunscreen, and multiple behaviors). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.
Experimental: Indoor Tanning Behavior

A convenience sample of white, English-speaking females ages 18 to 25 will be recruited via online advertisements and flyers in Philadelphia and the surrounding region (within a 30 mile radius). The investigators will recruit 60 adults to test indoor tanning messages.

The inclusion criteria are that adults must be white, female, must be between 18-25 years old, must have used an indoor tanning bed at least once in the past 12 months, and must speak English.
Behavioral: Indoor Tanning Behavior
Upon arrival, participants will provide informed consent and complete a short background questionnaire about usual indoor tanning, sun exposure and protection behaviors, and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a typical computer monitor, keyboard and mouse setup. Each participant will view messages with each type of target behavior (freedom, health risk, appearance)). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Laboratory Survey
Time Frame: Baseline
Questionnaire measures will be completed using an iPad with Qualtrics software. Participants will be asked to evaluate each message for its argument strength, emotional appeal, and themes; participants will also be asked about their intentions and beliefs related to each behavior. The research technician will not initiate a conversation with the participant during the experimental session except to give instructions.
Baseline
Follow-up Survey
Time Frame: Two weeks post baseline Laboratory Survey
Two weeks after the completed laboratory session, participants will be emailed a link to complete a follow-up survey. The survey will ask about participants' ability to recall the messages, attitudes regarding outdoor sun protection behaviors, actual behaviors in the past two weeks, whether the participants have used or will use the product they selected, and whether the participants have discussed the messages with anyone else.
Two weeks post baseline Laboratory Survey

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure of Behavioral Intent
Time Frame: Baseline
Upon finishing the experiment, respondents will be offered a choice of one of four "thank you" gifts of comparable value: sunscreen, hand sanitizer, and moisturizer with or without SPF protection. The experimenter will unobtrusively record the subjects' selections.
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Glanz, PhD, MPH, University of Pennsylvania

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 821348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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 Behavior, Health

Clinical Trials on Outdoor Sun Behavior

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings