Investigation of a Behavioral Substitute for Sunbathing

NCT00403377 | Completed Phase 1

• 4 other identifiers: CDR0000499830R21CA109670UMASS-MCC-H-12102UMASS-MCC-H-11924
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin); Skin Cancer

Keywords

melanoma; basal cell carcinoma of the skin; squamous cell carcinoma of the skin

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Phase 1 SO: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes

  Baseline and Focus Group

• Phase II SO: Sunburn frequency in random beach goers at 2 and 12 months

  Baseline, 2-, and 12-months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Intervention

Control

NO INTERVENTION

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.

Interventions

Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• 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.

  PMID: 19196482 RESULT

• 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.

  PMID: 20855696 DERIVED

MeSH Terms

Conditions

Melanoma; Skin Neoplasms; Carcinoma, Basal Cell

Interventions

Methods

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sherry L. Pagoto, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

US (1)