Investigation of a Behavioral Substitute for Sunbathing

Melanoma (Skin) Clinical Trial

Official title:

Investigation of a Behavioral Substitute for Sunbathing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403377
• Other study ID #: CDR0000499830
• Secondary ID: R21CA109670UMASS
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 21, 2006
• Last updated: September 29, 2015
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: September 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Melanoma (Skin)
• Skin Cancer

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 PO: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them	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.	Baseline and Focus Group	No
Primary	Phase II PO: Effectiveness of a beach-based pilot intervention (sun exposure at 2-, and 12- months follow-up)	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.	Baseline, 2-, and 12-months	No
Secondary	Phase 1 SO: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes	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.	Baseline and Focus Group	No
Secondary	Phase II SO: Sunburn frequency in random beach goers at 2 and 12 months	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.	Baseline, 2-, and 12-months	No