Investigation of a Behavioral Substitute for Sunbathing
NCT ID: NCT00403377
Last Updated: 2015-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
307 participants
INTERVENTIONAL
2006-04-30
2007-12-31
Brief Summary
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PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning products and how well sunless tanning products work as a substitute for sunbathing in healthy participants.
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Detailed Description
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Primary
* Determine participants' attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them. (Phase I)
* Determine participants' opinions, suggestions, and preferences regarding use of sunless tanning products. (Phase I)
* Determine the validity and reliability of the Sunless Tanning Attitudes Survey.
* Determine time spent sunbathing in random beach-goers. (Phase II)
Secondary
* Determine sunburn frequency in random beach-goers. (Phase II)
* Determine the use of a sunless tanner in these participants. (Phase II)
* Determine sun protection use in these participants. (Phase II)
* Determine perceptions of sun protection, susceptibility to photoaging, benefits of sunbathing, and severity of photoaging. (Phase II)
OUTLINE: This is an open-label phase I study followed by a pilot, randomized, controlled phase II study.
* Phase I (focus group): Participants complete the Sunless Tanning Attitudes (STA) survey, Sun Behavior (SB) survey, and the Decisional Balance for Sun Exposure and Sun Protection Questionnaire. Participants who have used a sunless tanner in the past also complete the Sunless Tanner Users (STU) survey. Participants receive sunless tanning lotion and instructions for its use. Participants are instructed to use the sunless tanner for 2 weeks (≥ 3 applications). Participants then complete the STA, SB, and STU surveys and participate in a focus group.
* Phase II:Participants are stratified by beach location and randomized to 1 of 2 intervention arms.
* Arm I: Participants complete surveys as in phase I. Photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
* Arm II: Participants complete surveys as in phase I. A souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study.
In both arms, participants complete surveys again at 2 and 12 months.
PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Intervention
Phase II include two arms. In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
Intervention
In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
Control
Phase II include two arms. In the control arm, a souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study.
No interventions assigned to this group
Interventions
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Intervention
In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
Eligibility Criteria
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Inclusion Criteria
* Self-described sun bather (phase I)
* Intentional sun exposure lasting ≥ 1 hour to get a tan (outside or via tanning salon) at least twice a month during the months of June to August of the prior year
* Intends to continue tanning during the coming summer months
* Random beach-goer (phase II)
PATIENT CHARACTERISTICS:
* Female
* Must speak English
* Must be able to read at the 6th grade level
* No prior sunless tanning products (phase I)
18 Years
120 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Massachusetts, Worcester
OTHER
Responsible Party
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Principal Investigators
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Sherry L. Pagoto, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
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University of Massachusetts Medical School
Worcester, Massachusetts, United States
Countries
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References
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Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Merriam P, Ma Y. Design and methods for a cluster randomized trial of the Sunless Study: a skin cancer prevention intervention promoting sunless tanning among beach visitors. BMC Public Health. 2009 Feb 5;9:50. doi: 10.1186/1471-2458-9-50.
Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Ma Y. The sunless study: a beach randomized trial of a skin cancer prevention intervention promoting sunless tanning. Arch Dermatol. 2010 Sep;146(9):979-84. doi: 10.1001/archdermatol.2010.203.
Other Identifiers
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UMASS-MCC-H-12102
Identifier Type: OTHER
Identifier Source: secondary_id
UMASS-MCC-H-11924
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000499830
Identifier Type: -
Identifier Source: org_study_id
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