Investigation of a Behavioral Substitute for Sunbathing

University of Massachusetts, Worcester

Status and phase: Completed; Phase 2; Phase 1

Conditions: Melanoma (Skin); Skin Cancer

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00403377

UMASS-MCC-H-12102 (Other Identifier)

UMASS-MCC-H-11924 (Other Identifier)

R21CA109670 (U.S. NIH Grant/Contract)

CDR0000499830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 307 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

307 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention

Control

No Intervention group

Description:

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.