Behavioral Intervention in Reducing Indoor Tanning

• Sponsor: Jerod L Stapleton, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03448224
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 54
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.7
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subject	Other: Questionnaire Administration; Other: Internet-Based Intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Development and Evaluation of a Behavioral Intervention to Reduce Indoor Tanning
• Actual Study Start Date: Apr 11, 2018
• Actual Primary Completion Date: Feb 6, 2019
• Actual Study Completion Date: Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Questionnaire Administration; Questionnaire; Other: Internet-Based Intervention; Intervention
Active Comparator: Group II (wait-list) Participants are placed on wait-list and may receive full intervention after follow-up.	Other: Questionnaire Administration; Questionnaire

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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").

2. 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.

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Use of IT at least 25 times in the past year

• Women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• Jerod L Stapleton, PhD
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jerod Stapleton, PhD, University of Kentucky

Study Documents (Full-Text)

• Informed Consent Form - Jan 25, 2019
• Study Protocol and Statistical Analysis Plan - Jan 25, 2019

More Information

Publications

None provided.

• Responsible Party: Jerod L Stapleton, PhD, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT03448224
• Other Study ID Numbers: 131315; NCI-2018-00063; Pro2013003349; 131315; K07CA175115; P30CA072720
• First Posted: Feb 28, 2018
• Last Update Posted: Oct 22, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

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 Detail	One participant removed after assignment because of failed quality check with baseline data.

Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)	Group II (Wait-list)
Arm/Group Description	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	Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire
Period Title: Overall Study
STARTED	28	26
COMPLETED	27	26
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)	Group II (Wait-list)	Total
Arm/Group Description	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	Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire	Total of all reporting groups
Overall Participants	27	26	53
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	27 100%	26 100%	53 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.88 (1.66)	22.29 (2.05)	22.60 (1.86)
Sex: Female, Male (Count of Participants)
Female	27 100%	26 100%	53 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 18.5%	3 11.5%	8 15.1%
Not Hispanic or Latino	22 81.5%	23 88.5%	45 84.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Causasian/White	24 88.9%	21 80.8%	45 84.9%
Black or African American	1 3.7%	2 7.7%	3 5.7%
Other	2 7.4%	3 11.5%	5 9.4%

Outcome Measures

1. Primary Outcome

Title	Number of Prior 2-Month Indoor Tanning Sessions Reported by Participants on a Follow-up Survey
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)	Group II (Wait-list)
Arm/Group Description	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	Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire
Measure Participants	27	26
Mean (Standard Deviation) [indoor tanning sessions]	11.5 (2.1)	7.9 (2.1)

2. Secondary Outcome

Title	Perceived Difficulty (Self-efficacy) in Quitting Tanning
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)	Group II (Wait-list)
Arm/Group Description	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	Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire
Measure Participants	27	26
Mean (Standard Deviation) [score on a scale]	5.0 (0.6)	5.0 (0.6)

3. Secondary Outcome

Title	Sunburns
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)	Group II (Wait-list)
Arm/Group Description	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	Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire
Measure Participants	27	26
Mean (Standard Deviation) [sunburns]	1.9 (0.4)	1.1 (0.4)

4. Secondary Outcome

Title	Intentions to Use Indoor Tanning
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)	Group II (Wait-list)
Arm/Group Description	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	Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire
Measure Participants	27	26
Mean (Standard Deviation) [score on a scale]	5.0 (0.3)	4.8 (0.3)

5. Secondary Outcome

Title	Number of Participants Expressing Positive Interest in Changing Tanning
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)	Group II (Wait-list)
Arm/Group Description	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	Participants are placed on wait-list and receive full intervention after follow-up. Questionnaire Administration: Questionnaire
Measure Participants	27	26
Count of Participants [Participants]	18 66.7%	12 46.2%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	The definition does not differ.
Arm/Group Title	Group I (Web-based Indoor Tanning Intervention)		Group II (Wait-list)
Arm/Group Description	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		Participants are placed on wait-list and may receive full intervention after follow-up. Questionnaire Administration: Questionnaire
All Cause Mortality
	Group I (Web-based Indoor Tanning Intervention)		Group II (Wait-list)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)
Serious Adverse Events
	Group I (Web-based Indoor Tanning Intervention)		Group II (Wait-list)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Group I (Web-based Indoor Tanning Intervention)		Group II (Wait-list)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.