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Pilot Investigation of Behavioral Alternatives to Indoor Tanning

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Airbrush
Airbrush Plus
Delayed Airbrush
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Airbrush

Airbrush Plus

Delayed Airbrush Plus

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Satisfaction
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.
Effort of alternatives
Perceived effort of alternatives will be discussed in a focus group setting.
Recruitment rate
Total randomized and total screened out.
Retention
% sessions complete and total withdrawn from study

Secondary Outcome Measures

abstinence
the percent of participants who abstained from indoor tanning.
abstinence
the percent of participants who abstained from indoor tanning.
abstinence
the percent of participants who abstained from indoor tanning.
abstinence
the percent of participants who abstained from indoor tanning.

Full Information

First Posted
June 9, 2014
Last Updated
May 5, 2015
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT02192918
Brief Title
Pilot Investigation of Behavioral Alternatives to Indoor Tanning
Official Title
Pilot Investigation of Behavioral Alternatives to Indoor Tanning
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Airbrush
Arm Type
Experimental
Arm Description
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.
Arm Title
Airbrush Plus
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Airbrush Plus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Airbrush
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Airbrush Plus
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Delayed Airbrush
Intervention Description
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
Primary Outcome Measure Information:
Title
Satisfaction
Description
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.
Time Frame
up to 12 months
Title
Effort of alternatives
Description
Perceived effort of alternatives will be discussed in a focus group setting.
Time Frame
6-month follow-up
Title
Recruitment rate
Description
Total randomized and total screened out.
Time Frame
baseline
Title
Retention
Description
% sessions complete and total withdrawn from study
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
abstinence
Description
the percent of participants who abstained from indoor tanning.
Time Frame
2-month follow-up
Title
abstinence
Description
the percent of participants who abstained from indoor tanning.
Time Frame
3-month follow-up
Title
abstinence
Description
the percent of participants who abstained from indoor tanning.
Time Frame
6-month follow-up
Title
abstinence
Description
the percent of participants who abstained from indoor tanning.
Time Frame
12-month follow-up
Other Pre-specified Outcome Measures:
Title
Cost of indoor tanning
Description
Total amount spent on tanning since the previous assessment.
Time Frame
2-month follow-up
Title
Cost of indoor tanning
Description
Total amount spent on tanning since the previous assessment.
Time Frame
3-month follow-up
Title
Cost of indoor tanning
Description
Total amount spent on tanning since the previous assessment.
Time Frame
6-month follow-up
Title
Cost of indoor tanning
Description
Total amount spent on tanning since the previous assessment.
Time Frame
12-month follow-up
Title
Stress Level
Description
Perceived Stress Scale
Time Frame
2-month follow-up
Title
Stress Level
Description
Perceived Stress Scale
Time Frame
3-month follow-up
Title
Stress Level
Description
Perceived Stress Scale
Time Frame
6-month follow-up
Title
Stress Level
Description
Perceived Stress Scale
Time Frame
12-month follow-up
Title
Attitudes
Description
Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
Time Frame
3-month follow-up
Title
Attitudes
Description
Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
Time Frame
6-month follow-up
Title
Attitudes
Description
Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
Time Frame
12-month follow-up
Title
Tanning Dependence
Description
modified CAGE
Time Frame
2-month follow-up
Title
Tanning Dependence
Description
modified CAGE
Time Frame
3-month follow-up
Title
Tanning Dependence
Description
modified CAGE
Time Frame
6-month follow-up
Title
Tanning Dependence
Description
modified CAGE
Time Frame
12-month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry Pagoto, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

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Pilot Investigation of Behavioral Alternatives to Indoor Tanning

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