- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03201120
Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- CIRNA Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
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. |
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. |
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
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.
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Baseline
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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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Glanz, PhD, MPH, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 821348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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