Sunless Tanning Products as a Substitute for Sunbathing in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00403377
First received: November 21, 2006
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Non-melanomatous Skin Cancer
Drug: sunless tanning lotion
Drug: sunscreen lotion
Other: counseling intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Investigation of a Behavioral Substitute for Sunbathing

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Aim 1: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them (Phase I) [ Time Frame: December 2005 - May 2006 ] [ Designated as safety issue: No ]
    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.

  • Aim 2: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes (Phase I) [ Time Frame: March 2006 - May 2006 ] [ Designated as safety issue: No ]
    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.

  • Aim 3: Effectiveness of a beach-based pilot intervention (sun exposure at 2-, and 12- months follow-up)(Phase II) [ Time Frame: Aug-Sept 2006 & Jul-Aug 2007 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Aim 3: Sunburn frequency in random beach goers at 2 and 12 months (Phase II) [ Time Frame: Aug-Sept 2006 & Jul-Aug 2007 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 330
Study Start Date: April 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sunless tanning lotion
    Participants in completing the phase 1 focus groups will be given a sunless tanning product of their choice to use for 2 weeks. Participants in the phase 2 intervention condition will be given sunless tanning lotion.
    Drug: sunscreen lotion
    Participants in the phase 2 intervention condition will be given sunscreen.
    Other: counseling intervention
    Participants in the phase 2 intervention condition will receive education about skin cancer, sunless tanning, and sunblock.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

PRIOR CONCURRENT THERAPY:

  • No prior sunless tanning products (phase II)

    • Patients enrolled in phase I may or may not have used sunless tanning products
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403377

Locations
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Sherry L. Pagoto, PhD University of Massachusetts, Worcester
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sherry Pagoto, Ph.D., University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT00403377     History of Changes
Other Study ID Numbers: CDR0000499830, R21CA109670, UMASS-MCC-H-12102, UMASS-MCC-H-11924
Study First Received: November 21, 2006
Last Updated: August 2, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Massachusetts, Worcester:
melanoma
basal cell carcinoma of the skin
squamous cell carcinoma of the skin

Additional relevant MeSH terms:
Skin Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014