Sunless Tanning Products as a Substitute for Sunbathing in Healthy Participants
RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help doctors plan effective ways to prevent skin cancer caused by sunbathing.
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.
Non-melanomatous Skin Cancer
Drug: sunless tanning lotion
Drug: sunscreen lotion
Other: counseling intervention
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Investigation of a Behavioral Substitute for Sunbathing|
- Aim 1: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them (Phase I) [ Time Frame: December 2005 - May 2006 ] [ Designated as safety issue: No ]The goal of the initial developmental phase of the present study is to determine the acceptability of sunless tanning as a substitute for sunbathing. Using focus groups comprised of sunbathers given the opportunity to sample sunless tanning products, we will identify perceived barriers and benefits of sunless tanning products, develop motivational messages encouraging the use of sunless tanning products, and preview intervention materials.
- Aim 2: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes (Phase I) [ Time Frame: March 2006 - May 2006 ] [ Designated as safety issue: No ]To achieve this aim, psychometric analyses including inter-item analyses, autocorrelations, internal consistency, convergent and divergent validity will be conducted, and survey items will be added/revised (if necessary) based on content of focus group discussions.
- Aim 3: Effectiveness of a beach-based pilot intervention (sun exposure at 2-, and 12- months follow-up)(Phase II) [ Time Frame: Aug-Sept 2006 & Jul-Aug 2007 ] [ Designated as safety issue: No ]The intervention will include sun damage imaging, sun safety and sunless tanning education/instruction, and the provision of samples of both sunscreen and sunless tanning products. Feasibility of the intervention, measures, and follow-up procedures will be assessed. The primary outcome for effectiveness will be sun exposure at 2-, and 12- months follow-up and a questionnaire only control group will be employed for comparison.
- Aim 3: Sunburn frequency in random beach goers at 2 and 12 months (Phase II) [ Time Frame: Aug-Sept 2006 & Jul-Aug 2007 ] [ Designated as safety issue: No ]The intervention will include sun damage imaging, sun safety and sunless tanning education/instruction, and the provision of samples of both sunscreen and sunless tanning products. Feasibility of the intervention, measures, and follow-up procedures will be assessed. Secondary outcomes will include frequency of sunburns, use of sunless tanning products, sun protection behavior, and perceived benefits/barriers to sunbathing/sun protection.
|Study Start Date:||April 2006|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: sunless tanning lotion
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403377
|United States, Massachusetts|
|UMASS Memorial Cancer Center - University Campus|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Sherry L. Pagoto, PhD||University of Massachusetts, Worcester|