NCT00709306

Brief Summary

The purpose of the proposed project is to investigate the efficacy and longevity of two novel approaches to changing skin protection behaviors: 1) UV-detect photos that reveal currently existing skin damage and 2) motivational interviewing (MI), a person-centered, yet directive counseling style used to enhance internal motivation to change health behaviors. The proposed investigations include a pilot study to refine the methodology; a small formal randomized controlled efficacy trial; and a dismantling study. These studies will also expand current knowledge and research in several major ways: 1) the use of UV-detect photos will enable highly salient and personalized feedback, 2) MI will be used in a previously untried health domain (skin cancer prevention), 3) objective skin color changes will be measured using state-of-the-art skin reflectance spectrophotometry, and 4) the proposed studies will test aspects of several major psychological theories (e.g., Transtheoretical Model, Prototype/Willingness Model) to identify moderators/mediators of outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

February 22, 2018

Completed
Last Updated

August 31, 2018

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

July 1, 2008

Results QC Date

November 10, 2017

Last Update Submit

July 31, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sun Stage of Change at 3 Months

    The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).

    3 months

  • Sun Stage of Change at 12 Months

    The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).

    12 months

Study Arms (4)

Education

PLACEBO COMPARATOR

Participants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.

Behavioral: Education

Motivational Interviewing

ACTIVE COMPARATOR

Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. These sessions took about 22 minutes.

Behavioral: Motivational Interviewing

UV-detect photos

ACTIVE COMPARATOR

Participants were shown a regular black and white photo and a black and white UV-filtered photo of their face. Participants were told that "Any dark, spotted, freckled, wrinkled, uneven, or pitted areas indicate existing underlying skin damage that is difficult to reverse. However, protecting the skin from UV radiation can prevent future damage." Participants were asked what they noticed about the photos, what their reactions were, and how this might affect their behavior. These sessions took 12 minutes on average.

Device: UV-Detect Photos

UV-detect photos & MI

EXPERIMENTAL

Participants met with a trained counselor who reviewed any personalized feedback of risk derived from the baseline assessments (e.g., history of sunburns, self-reported UV exposure, protective behaviors). Counselors utilized the basic motivational interviewing skills of open-ended questions, reflection of participant statements, affirmations/positive feedback, and summation of major points throughout the discussion. In addition to baseline feedback, participants were also interviewed about the black \& white and UV-filtered photos of their faces. These sessions took about 25 minutes.

Device: UV-Detect PhotosBehavioral: Motivational Interviewing

Interventions

UV-Detect Photos

UV-detect photosUV-detect photos & MI

Motivational Interviewing

Motivational InterviewingUV-detect photos & MI
EducationBEHAVIORAL

Education

Education

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • or older

You may not qualify if:

  • Visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19012, United States

Location

MeSH Terms

Interventions

Motivational InterviewingEducational Status

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Carolyn Heckman, PhD
Organization
Fox Chase Cancer Center

Study Officials

  • Carolyn Heckman, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

March 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2010

Last Updated

August 31, 2018

Results First Posted

February 22, 2018

Record last verified: 2018-07

Locations