Clinical trial NCT00403377: Investigation of a Behavioral Substitute for Sunbathing
Official title: Investigation of a Behavioral Substitute for Sunbathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Melanoma (Skin)
Skin Cancer
Keywords: melanoma
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-23
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Phase 1 PO: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them
timeFrame: Baseline and Focus Group
measure: Phase II PO: Effectiveness of a beach-based pilot intervention (sun exposure at 2-, and 12- months follow-up)
timeFrame: Baseline, 2-, and 12-months
Secondary outcomes:
measure: Phase 1 SO: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes
timeFrame: Baseline and Focus Group
measure: Phase II SO: Sunburn frequency in random beach goers at 2 and 12 months
timeFrame: Baseline, 2-, and 12-months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Sherry L. Pagoto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.