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

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.

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

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.
74

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
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

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

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

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: 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.
Behavioral: Airbrush
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.
Behavioral: Airbrush Plus
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.
Behavioral: Delayed Airbrush
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

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
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.
up to 12 months
Effort of alternatives
Time Frame: 6-month follow-up
Perceived effort of alternatives will be discussed in a focus group setting.
6-month follow-up
Recruitment rate
Time Frame: baseline
Total randomized and total screened out.
baseline
Retention
Time Frame: 12 month follow-up
% sessions complete and total withdrawn from study
12 month follow-up

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
abstinence
Time Frame: 2-month follow-up
the percent of participants who abstained from indoor tanning.
2-month follow-up
abstinence
Time Frame: 3-month follow-up
the percent of participants who abstained from indoor tanning.
3-month follow-up
abstinence
Time Frame: 6-month follow-up
the percent of participants who abstained from indoor tanning.
6-month follow-up
abstinence
Time Frame: 12-month follow-up
the percent of participants who abstained from indoor tanning.
12-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
Cost of indoor tanning
Time Frame: 3-month follow-up
Total amount spent on tanning since the previous assessment.
3-month follow-up
Cost of indoor tanning
Time Frame: 6-month follow-up
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
Stress Level
Time Frame: 2-month follow-up
Perceived Stress Scale
2-month follow-up
Stress Level
Time Frame: 3-month follow-up
Perceived Stress Scale
3-month follow-up
Stress Level
Time Frame: 6-month follow-up
Perceived Stress Scale
6-month follow-up
Stress Level
Time Frame: 12-month follow-up
Perceived Stress Scale
12-month follow-up
Attitudes
Time Frame: 3-month follow-up
Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
3-month follow-up
Attitudes
Time Frame: 6-month follow-up
Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
6-month follow-up
Attitudes
Time Frame: 12-month follow-up
Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
12-month follow-up
Tanning Dependence
Time Frame: 2-month follow-up
modified CAGE
2-month follow-up
Tanning Dependence
Time Frame: 3-month follow-up
modified CAGE
3-month follow-up
Tanning Dependence
Time Frame: 6-month follow-up
modified CAGE
6-month follow-up
Tanning Dependence
Time Frame: 12-month follow-up
modified CAGE
12-month follow-up

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 Massachusetts, Worcester

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: 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

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.
April 1, 2012

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.
April 1, 2015

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.
April 1, 2015

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 9, 2014

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.
July 16, 2014

First Posted (Estimate)

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.
July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
May 6, 2015

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.
May 5, 2015

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.
May 1, 2015

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.
  • 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.

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