Investigation of a Behavioral Substitute for Sunbathing
Condition: Melanoma (Skin); Skin Cancer
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: melanoma; basal cell carcinoma of the skin; squamous cell carcinoma of the skin