Pilot Investigation of Behavioral Alternatives to Indoor Tanning

Skin Cancer Clinical Trial

Official title:

Pilot Investigation of Behavioral Alternatives to Indoor Tanning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192918
• Other study ID #: 1R21CA161576-01A1
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: May 5, 2015
• Start date: April 2012
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Skin Cancer

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of indoor tanning	Total amount spent on tanning since the previous assessment.	2-month follow-up	No
Other	Cost of indoor tanning	Total amount spent on tanning since the previous assessment.	3-month follow-up	No
Other	Cost of indoor tanning	Total amount spent on tanning since the previous assessment.	6-month follow-up	No
Other	Cost of indoor tanning	Total amount spent on tanning since the previous assessment.	12-month follow-up	No
Other	Stress Level	Perceived Stress Scale	2-month follow-up	No
Other	Stress Level	Perceived Stress Scale	3-month follow-up	No
Other	Stress Level	Perceived Stress Scale	6-month follow-up	No
Other	Stress Level	Perceived Stress Scale	12-month follow-up	No
Other	Attitudes	Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives	3-month follow-up	No
Other	Attitudes	Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives	6-month follow-up	No
Other	Attitudes	Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives	12-month follow-up	No
Other	Tanning Dependence	modified CAGE	2-month follow-up	No
Other	Tanning Dependence	modified CAGE	3-month follow-up	No
Other	Tanning Dependence	modified CAGE	6-month follow-up	No
Other	Tanning Dependence	modified CAGE	12-month follow-up	No
Primary	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.	up to 12 months	No
Primary	Effort of alternatives	Perceived effort of alternatives will be discussed in a focus group setting.	6-month follow-up	No
Primary	Recruitment rate	Total randomized and total screened out.	baseline	No
Primary	Retention	% sessions complete and total withdrawn from study	12 month follow-up	No
Secondary	abstinence	the percent of participants who abstained from indoor tanning.	2-month follow-up	No
Secondary	abstinence	the percent of participants who abstained from indoor tanning.	3-month follow-up	No
Secondary	abstinence	the percent of participants who abstained from indoor tanning.	6-month follow-up	No
Secondary	abstinence	the percent of participants who abstained from indoor tanning.	12-month follow-up	No