Investigation of a Behavioral Substitute for Sunbathing

September 29, 2015 updated by: University of Massachusetts, Worcester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 PO: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them
Time Frame: Baseline and Focus Group
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)
Time Frame: Baseline, 2-, and 12-months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 SO: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes
Time Frame: Baseline and Focus Group
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.
Baseline and Focus Group
Phase II SO: Sunburn frequency in random beach goers at 2 and 12 months
Time Frame: Baseline, 2-, and 12-months
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.
Baseline, 2-, and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sherry L. Pagoto, PhD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000499830
  • R21CA109670 (U.S. NIH Grant/Contract)
  • UMASS-MCC-H-12102 (Other Identifier: University of Massachusetts Medical School)
  • UMASS-MCC-H-11924 (Other Identifier: University of Massachusetts Medical School)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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