Healthy Subject
Conditions
Brief summary
This randomized clinical trial tests the efficacy of a behavioral intervention works in reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of developing skin cancers. Behavioral interventions use techniques to help participants change the way they react to environmental triggers that may cause a negative reaction.
Detailed description
PRIMARY OBJECTIVE: To develop and evaluate an online tailored indoor tanning (IT) intervention based on findings from phase 1. OUTLINE: INTERVENTION: Participants are randomized to 1 of 2 groups. GROUP I: Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks. GROUP II: Participants are placed on wait-list and may receive full intervention after follow-up. After completion of study, patients are followed up at 3 months.
Interventions
OTHERQuestionnaire Administration
Questionnaire
OTHERInternet-Based Intervention
Intervention
Sponsors
National Cancer Institute (NCI)
Jerod L Stapleton, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Use of IT at least 25 times in the past year * Women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey | Up to 3 months | On the follow-up assessment administered 3 months after the baseline assessment, participants will estimate the number of times they used a tanning bed or booth with tanning lamps in the past 2 months with an open-ended response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Difficulty (Self-efficacy) in Quitting Tanning | At 3 months post-intervention | Measured at post-intervention data collection (3 months post intervention) using single item assessment: How hard would it be for you to stop using tanning beds/booths? (Please answer on a scale for 0-10, where 0 is Not at all hard, 10 is Extremely hard). |
| Sunburns | Up to 3 months | On the follow-up assessment administered 3 months after the baseline assessment, participants will estimate the number of times they had a sunburn in the past 2 months with an open-ended response. |
| Intentions to Use Indoor Tanning | Up to 3 months | For tanning intentions, participants indicated how likely they were to use an indoor tanning bed in the next year on a 6-point response scale anchored with 1 = Extremely unlikely and 6 = Extremely likely |
| Number of Participants Expressing Positive Interest in Changing Tanning | 3 months | Interest in changing tanning was assessed using a single item: Would you like to reduce or quit indoor tanning if you could do so easily? Responses coded as 0 = no and 1 = yes |
Countries
United States
Participant flow
Recruitment details
Qualtrics Sample Providers emailed advertisements for an online screening survey to members of internet panels and posted online advertisements. Recruitment flyers with contact information were posted on campus and in classrooms and on internet ads on social media and Craigslist. Baseline assessments were completed between April and November 2018
Pre-assignment details
One participant removed after assignment because of failed quality check with baseline data.
Participants by arm
| Arm | Count |
|---|---|
| Group I (Web-based Indoor Tanning Intervention) Participants receive intervention, weekly text messages about IT reduction, and personalized booster intervention. Participants then receive text messages twice weekly for 4 weeks.
Questionnaire Administration: Questionnaire
Internet-Based Intervention: Intervention | 27 |
| Group II (Wait-list) Participants are placed on wait-list and receive full intervention after follow-up.
Questionnaire Administration: Questionnaire | 26 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Provided same answer to every question | 1 | 0 |
Baseline characteristics
| Characteristic | Group I (Web-based Indoor Tanning Intervention) | Group II (Wait-list) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 26 Participants | 53 Participants |
| Age, Continuous | 22.88 years STANDARD_DEVIATION 1.66 | 22.29 years STANDARD_DEVIATION 2.05 | 22.60 years STANDARD_DEVIATION 1.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 23 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race: Customized Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race: Customized Causasian/White | 24 Participants | 21 Participants | 45 Participants |
| Race/Ethnicity, Customized Race: Customized Other | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
Primary
Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey
On the follow-up assessment administered 3 months after the baseline assessment, participants will estimate the number of times they used a tanning bed or booth with tanning lamps in the past 2 months with an open-ended response.
Time frame: Up to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Web-based Indoor Tanning Intervention) | Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey | 11.5 indoor tanning sessions | Standard Deviation 2.1 |
| Group II (Wait-list) | Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey | 7.9 indoor tanning sessions | Standard Deviation 2.1 |
Secondary
Intentions to Use Indoor Tanning
For tanning intentions, participants indicated how likely they were to use an indoor tanning bed in the next year on a 6-point response scale anchored with 1 = Extremely unlikely and 6 = Extremely likely
Time frame: Up to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Web-based Indoor Tanning Intervention) | Intentions to Use Indoor Tanning | 5.0 score on a scale | Standard Deviation 0.3 |
| Group II (Wait-list) | Intentions to Use Indoor Tanning | 4.8 score on a scale | Standard Deviation 0.3 |
Secondary
Number of Participants Expressing Positive Interest in Changing Tanning
Interest in changing tanning was assessed using a single item: Would you like to reduce or quit indoor tanning if you could do so easily? Responses coded as 0 = no and 1 = yes
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group I (Web-based Indoor Tanning Intervention) | Number of Participants Expressing Positive Interest in Changing Tanning | 18 Participants |
| Group II (Wait-list) | Number of Participants Expressing Positive Interest in Changing Tanning | 12 Participants |
Secondary
Perceived Difficulty (Self-efficacy) in Quitting Tanning
Measured at post-intervention data collection (3 months post intervention) using single item assessment: How hard would it be for you to stop using tanning beds/booths? (Please answer on a scale for 0-10, where 0 is Not at all hard, 10 is Extremely hard).
Time frame: At 3 months post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Web-based Indoor Tanning Intervention) | Perceived Difficulty (Self-efficacy) in Quitting Tanning | 5.0 score on a scale | Standard Deviation 0.6 |
| Group II (Wait-list) | Perceived Difficulty (Self-efficacy) in Quitting Tanning | 5.0 score on a scale | Standard Deviation 0.6 |
Secondary
Sunburns
On the follow-up assessment administered 3 months after the baseline assessment, participants will estimate the number of times they had a sunburn in the past 2 months with an open-ended response.
Time frame: Up to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Web-based Indoor Tanning Intervention) | Sunburns | 1.9 sunburns | Standard Deviation 0.4 |
| Group II (Wait-list) | Sunburns | 1.1 sunburns | Standard Deviation 0.4 |