- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192918
Pilot Investigation of Behavioral Alternatives to Indoor Tanning
May 5, 2015 updated by: Sherry Pagoto, University of Massachusetts, Worcester
The goal of this research is to develop and test the feasibility of an intervention that stimulates uptake of healthy alternatives to tanning by providing free access to them for a limited time.
Free access gives participants a low-risk opportunity to try something new that is consistent with their motivations.
Free access also allows them to experience the reinforcing properties of the alternatives which could prime continued use after the free trial period.
The objective of the present study is to determine the feasibility and short-term efficacy of providing free alternatives to indoor tanners in an effort to "nudge" them to switch from indoor tanning to healthy alternatives.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Melanoma is the second most common cancer diagnosed in young women and is responsible for nearly 8,000 US deaths per year.
Exposure to ultraviolet radiation (UVR) increases risk for melanoma.
The International Agency for Research on Cancer assigned indoor tanning (IT; use of tanning beds or booths), as a class 1 carcinogen joining arsenic, asbestos, and mustard gas.
Unfortunately, interventions educating tanners about the risks have not been very effective.
Many tanners are more motivated by the immediate consequences of tanning than the delayed consequence of possibly getting cancer.
Research shows the primary motivation for indoor tanning is to improve physical appearance, but a secondary motivation is stress reduction.
Behavioral economics theory suggests that the rate of a behavior depends on 1) the reinforcing value of that behavior relative to alternatives, 2) the cost of engaging in the behavior relative to alternatives, and 3) the availability of the behavior relative to alternatives.
The purpose of the present study is to determine whether exposure to healthy alternatives changes the behavior of indoor tanners.
The investigators will randomize tanners to conditions differing in physical appearance and stress reduction alternatives to determine whether they can get their motivational needs met in healthier ways.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- 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
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
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-
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
Ages Eligible for Study
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Ages 16-65
- Report minimum of 10 indoor tanning visits in the last year with intentions to continue
Exclusion Criteria:
- Ages <16 or >65
- Pregnant, breastfeeding, or planning to become pregnant during the study period
- Reporting less than 10 indoor tanning visits per year
- No intention to continue indoor tanning
- Using sunless tanning more than once in the last year and ever in the last 3 months
- Physically limited to do yoga or dance classes
- DHA allergy
- Inability to consent
- Prisoners
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Airbrush
Participants will receive the American Academy of Dermatology Sun Smart pamphlet at the baseline session.
It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities.
Participants will also complete 4 airbrush tan sessions, once every two weeks, over the course of 2 months.
Participants will receive access to one of each of the following after the 6-month assessment at no cost: massage, pedicure, yoga class, and dance class.
Participants will schedule these activities on their own and the study staff will arrange for payment for the appointment.
|
The American Academy of Dermatology Sun Smart pamphlet will be given at the baseline session.
It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities.
Participants in the airbrush condition will receive 4 airbrush tan sessions, once every two weeks, over the course of 2 months.
|
|
Experimental: Airbrush Plus
Participants will receive the American Academy of Dermatology Sun Smart pamphlet at the baseline session.
It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities.
Participants will also complete 4 airbrush tan sessions, once every two weeks, over the course of 2 months.
Additionally, they may choose 8 sessions, 1 per week, of the following activities at no cost: massage, pedicure, yoga class, or dance class.
These activities are being given as healthy alternatives to the relaxation sensation of indoor tanning.
|
The American Academy of Dermatology Sun Smart pamphlet will be given at the baseline session.
It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities.
Participants will complete 4 airbrush tan sessions, once every two weeks, over the course of 2 months.
Additionally, they may choose 8 sessions, 1 per week, of the following activities at no cost: massage, pedicure, yoga class, or dance class.
|
|
Active Comparator: Delayed Airbrush Plus
Participants will receive the American Academy of Dermatology Sun Smart pamphlet at the baseline session.
It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities.
Participants will also receive access to one of each of the following after the 6-month assessment at no cost: airbrush tan, massage, pedicure, yoga class, and dance class.
|
The American Academy of Dermatology Sun Smart pamphlet will be given at the baseline session.
It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities.
Participants will receive access to one of each of the following after the 6-month assessment at no cost: airbrush tan, massage, pedicure, yoga class, and dance class
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction
Time Frame: up to 12 months
|
A measure of satisfaction will be assessed for each alternative visit on a scale of 1-10 immediately after each activity is completed.
Visits occur between baseline and 12 months of participation.
Timing of visits depend on which condition is assigned.
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up to 12 months
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Effort of alternatives
Time Frame: 6-month follow-up
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Perceived effort of alternatives will be discussed in a focus group setting.
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6-month follow-up
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Recruitment rate
Time Frame: baseline
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Total randomized and total screened out.
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baseline
|
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Retention
Time Frame: 12 month follow-up
|
% sessions complete and total withdrawn from study
|
12 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
abstinence
Time Frame: 2-month follow-up
|
the percent of participants who abstained from indoor tanning.
|
2-month follow-up
|
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abstinence
Time Frame: 3-month follow-up
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the percent of participants who abstained from indoor tanning.
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3-month follow-up
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abstinence
Time Frame: 6-month follow-up
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the percent of participants who abstained from indoor tanning.
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6-month follow-up
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abstinence
Time Frame: 12-month follow-up
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the percent of participants who abstained from indoor tanning.
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12-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost of indoor tanning
Time Frame: 2-month follow-up
|
Total amount spent on tanning since the previous assessment.
|
2-month follow-up
|
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Cost of indoor tanning
Time Frame: 3-month follow-up
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Total amount spent on tanning since the previous assessment.
|
3-month follow-up
|
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Cost of indoor tanning
Time Frame: 6-month follow-up
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Total amount spent on tanning since the previous assessment.
|
6-month follow-up
|
|
Cost of indoor tanning
Time Frame: 12-month follow-up
|
Total amount spent on tanning since the previous assessment.
|
12-month follow-up
|
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Stress Level
Time Frame: 2-month follow-up
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Perceived Stress Scale
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2-month follow-up
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Stress Level
Time Frame: 3-month follow-up
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Perceived Stress Scale
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3-month follow-up
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Stress Level
Time Frame: 6-month follow-up
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Perceived Stress Scale
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6-month follow-up
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Stress Level
Time Frame: 12-month follow-up
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Perceived Stress Scale
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12-month follow-up
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Attitudes
Time Frame: 3-month follow-up
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Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
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3-month follow-up
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Attitudes
Time Frame: 6-month follow-up
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Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
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6-month follow-up
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Attitudes
Time Frame: 12-month follow-up
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Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
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12-month follow-up
|
|
Tanning Dependence
Time Frame: 2-month follow-up
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modified CAGE
|
2-month follow-up
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Tanning Dependence
Time Frame: 3-month follow-up
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modified CAGE
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3-month follow-up
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Tanning Dependence
Time Frame: 6-month follow-up
|
modified CAGE
|
6-month follow-up
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Tanning Dependence
Time Frame: 12-month follow-up
|
modified CAGE
|
12-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sherry Pagoto, PhD, University of Massachusetts, Worcester
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
April 1, 2012
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
June 9, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 17, 2014
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21CA161576-01A1 (U.S. NIH Grant/Contract)
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.