<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02192918</url>
  </required_header>
  <id_info>
    <org_study_id>1R21CA161576-01A1</org_study_id>
    <nct_id>NCT02192918</nct_id>
  </id_info>
  <brief_title>Pilot Investigation of Behavioral Alternatives to Indoor Tanning</brief_title>
  <official_title>Pilot Investigation of Behavioral Alternatives to Indoor Tanning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research is to develop and test the feasibility of an intervention that&#xD;
      stimulates uptake of healthy alternatives to tanning by providing free access to them for a&#xD;
      limited time. Free access gives participants a low-risk opportunity to try something new that&#xD;
      is consistent with their motivations. Free access also allows them to experience the&#xD;
      reinforcing properties of the alternatives which could prime continued use after the free&#xD;
      trial period. The objective of the present study is to determine the feasibility and&#xD;
      short-term efficacy of providing free alternatives to indoor tanners in an effort to &quot;nudge&quot;&#xD;
      them to switch from indoor tanning to healthy alternatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Melanoma is the second most common cancer diagnosed in young women and is responsible for&#xD;
      nearly 8,000 US deaths per year. Exposure to ultraviolet radiation (UVR) increases risk for&#xD;
      melanoma. The International Agency for Research on Cancer assigned indoor tanning (IT; use of&#xD;
      tanning beds or booths), as a class 1 carcinogen joining arsenic, asbestos, and mustard gas.&#xD;
      Unfortunately, interventions educating tanners about the risks have not been very effective.&#xD;
      Many tanners are more motivated by the immediate consequences of tanning than the delayed&#xD;
      consequence of possibly getting cancer. Research shows the primary motivation for indoor&#xD;
      tanning is to improve physical appearance, but a secondary motivation is stress reduction.&#xD;
      Behavioral economics theory suggests that the rate of a behavior depends on 1) the&#xD;
      reinforcing value of that behavior relative to alternatives, 2) the cost of engaging in the&#xD;
      behavior relative to alternatives, and 3) the availability of the behavior relative to&#xD;
      alternatives. The purpose of the present study is to determine whether exposure to healthy&#xD;
      alternatives changes the behavior of indoor tanners. The investigators will randomize tanners&#xD;
      to conditions differing in physical appearance and stress reduction alternatives to determine&#xD;
      whether they can get their motivational needs met in healthier ways.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction</measure>
    <time_frame>up to 12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effort of alternatives</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Perceived effort of alternatives will be discussed in a focus group setting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>baseline</time_frame>
    <description>Total randomized and total screened out.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>12 month follow-up</time_frame>
    <description>% sessions complete and total withdrawn from study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>abstinence</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>the percent of participants who abstained from indoor tanning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abstinence</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>the percent of participants who abstained from indoor tanning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abstinence</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>the percent of participants who abstained from indoor tanning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abstinence</measure>
    <time_frame>12-month follow-up</time_frame>
    <description>the percent of participants who abstained from indoor tanning.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost of indoor tanning</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>Total amount spent on tanning since the previous assessment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost of indoor tanning</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>Total amount spent on tanning since the previous assessment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost of indoor tanning</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Total amount spent on tanning since the previous assessment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost of indoor tanning</measure>
    <time_frame>12-month follow-up</time_frame>
    <description>Total amount spent on tanning since the previous assessment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress Level</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>Perceived Stress Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress Level</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>Perceived Stress Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress Level</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Perceived Stress Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress Level</measure>
    <time_frame>12-month follow-up</time_frame>
    <description>Perceived Stress Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Attitudes</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives</description>
  </other_outcome>
  <other_outcome>
    <measure>Attitudes</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives</description>
  </other_outcome>
  <other_outcome>
    <measure>Attitudes</measure>
    <time_frame>12-month follow-up</time_frame>
    <description>Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives</description>
  </other_outcome>
  <other_outcome>
    <measure>Tanning Dependence</measure>
    <time_frame>2-month follow-up</time_frame>
    <description>modified CAGE</description>
  </other_outcome>
  <other_outcome>
    <measure>Tanning Dependence</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>modified CAGE</description>
  </other_outcome>
  <other_outcome>
    <measure>Tanning Dependence</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>modified CAGE</description>
  </other_outcome>
  <other_outcome>
    <measure>Tanning Dependence</measure>
    <time_frame>12-month follow-up</time_frame>
    <description>modified CAGE</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Airbrush</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Airbrush Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Airbrush Plus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Airbrush</intervention_name>
    <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.</description>
    <arm_group_label>Airbrush</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Airbrush Plus</intervention_name>
    <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.</description>
    <arm_group_label>Airbrush Plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Delayed Airbrush</intervention_name>
    <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</description>
    <arm_group_label>Delayed Airbrush Plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Ages 16-65&#xD;
&#xD;
          -  Report minimum of 10 indoor tanning visits in the last year with intentions to&#xD;
             continue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ages &lt;16 or &gt;65&#xD;
&#xD;
          -  Pregnant, breastfeeding, or planning to become pregnant during the study period&#xD;
&#xD;
          -  Reporting less than 10 indoor tanning visits per year&#xD;
&#xD;
          -  No intention to continue indoor tanning&#xD;
&#xD;
          -  Using sunless tanning more than once in the last year and ever in the last 3 months&#xD;
&#xD;
          -  Physically limited to do yoga or dance classes&#xD;
&#xD;
          -  DHA allergy&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry Pagoto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Worcester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>June 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>May 5, 2015</last_update_submitted>
  <last_update_submitted_qc>May 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Sherry Pagoto</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02192918
org study id: 1R21CA161576-01A1
nct id: NCT02192918
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Satisfaction
time frame: up to 12 months
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.
measure: Effort of alternatives
time frame: 6-month follow-up
description: Perceived effort of alternatives will be discussed in a focus group setting.
measure: Recruitment rate
time frame: baseline
description: Total randomized and total screened out.
measure: Retention
time frame: 12 month follow-up
description: % sessions complete and total withdrawn from study
measure: abstinence
time frame: 2-month follow-up
description: the percent of participants who abstained from indoor tanning.
measure: abstinence
time frame: 3-month follow-up
description: the percent of participants who abstained from indoor tanning.
measure: abstinence
time frame: 6-month follow-up
description: the percent of participants who abstained from indoor tanning.
measure: abstinence
time frame: 12-month follow-up
description: the percent of participants who abstained from indoor tanning.
measure: Cost of indoor tanning
time frame: 2-month follow-up
description: Total amount spent on tanning since the previous assessment.
measure: Cost of indoor tanning
time frame: 3-month follow-up
description: Total amount spent on tanning since the previous assessment.
measure: Cost of indoor tanning
time frame: 6-month follow-up
description: Total amount spent on tanning since the previous assessment.
measure: Cost of indoor tanning
time frame: 12-month follow-up
description: Total amount spent on tanning since the previous assessment.
measure: Stress Level
time frame: 2-month follow-up
description: Perceived Stress Scale
measure: Stress Level
time frame: 3-month follow-up
description: Perceived Stress Scale
measure: Stress Level
time frame: 6-month follow-up
description: Perceived Stress Scale
measure: Stress Level
time frame: 12-month follow-up
description: Perceived Stress Scale
measure: Attitudes
time frame: 3-month follow-up
description: Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
measure: Attitudes
time frame: 6-month follow-up
description: Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
measure: Attitudes
time frame: 12-month follow-up
description: Indoor Tanning Attitude Scale and the same scale modified for each of the alternatives
measure: Tanning Dependence
time frame: 2-month follow-up
description: modified CAGE
measure: Tanning Dependence
time frame: 3-month follow-up
description: modified CAGE
measure: Tanning Dependence
time frame: 6-month follow-up
description: modified CAGE
measure: Tanning Dependence
time frame: 12-month follow-up
description: modified CAGE
arm group label: Airbrush
arm group type: Experimental
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 group label: Airbrush Plus
arm group type: Experimental
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 group label: Delayed Airbrush Plus
arm group type: Active Comparator
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: Airbrush
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.
arm group label: Airbrush
intervention type: Behavioral
intervention name: Airbrush Plus
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.
arm group label: Airbrush Plus
intervention type: Behavioral
intervention name: Delayed Airbrush
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
arm group label: Delayed Airbrush Plus
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sherry Pagoto, PhD
role: Principal Investigator
affiliation: University of Massachusetts, Worcester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Sherry Pagoto
investigator title: Associate Professor
mesh term: Skin Neoplasms