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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00063 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro2013003349 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| 131315 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| K07CA175115 | U.S. NIH Grant/Contract | View source | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (web-based Indoor Tanning intervention) | Experimental | 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 (wait-list) | Active Comparator | Participants are placed on wait-list and may receive full intervention after follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | At 3 months post-intervention |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerod Stapleton, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33353412 | Derived | Stapleton JL, Ray AE, Glenn SD, McLouth LE, Parmar V, Manne SL. A randomized controlled trial of a web-based personalized feedback intervention targeting frequent indoor tanning bed users: Engagement, acceptability, and preliminary behavioral outcomes. J Health Psychol. 2022 Mar;27(4):923-935. doi: 10.1177/1359105320982038. Epub 2020 Dec 22. |
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One participant removed after assignment because of failed quality check with baseline data.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Group II (Wait-list) | Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | indoor tanning sessions | Up to 3 months |
|
The time frame from over which potential adverse events data were collected was during the intervention (duration of four weeks) through the time until follow-up data was collected (3 months post intervention) for a total of 4 months of observation for adverse events for each participant.
The definition does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerod Stapleton | University of Kentucky | 859.562.2802 | jerod.stapleton@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2019 | Aug 12, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2019 | Sep 14, 2020 | Prot_SAP_001.pdf |
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| Internet-Based Intervention | Other | Intervention |
|
| 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. | Up to 3 months |
| 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 | Up to 3 months |
| 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 | 3 months |
| Group II (Wait-list) |
Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire |
|
|
| 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"). | Posted | Mean | Standard Deviation | score on a scale | At 3 months post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | sunburns | Up to 3 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Up to 3 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Group II (Wait-list) | Participants are placed on wait-list and may receive full intervention after follow-up. Questionnaire Administration: Questionnaire | 0 | 26 | 0 | 26 | 0 | 26 |
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