The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention
1 other identifier
interventional
197
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
February 22, 2018
CompletedAugust 31, 2018
July 1, 2018
2.3 years
July 1, 2008
November 10, 2017
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 COMPARATORParticipants were given a packet of standard skin cancer prevention educational brochures and handouts from major professional organizations to review independently for 10-15 minutes.
Motivational Interviewing
ACTIVE COMPARATORParticipants 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.
UV-detect photos
ACTIVE COMPARATORParticipants 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.
UV-detect photos & MI
EXPERIMENTALParticipants 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.
Interventions
Motivational Interviewing
Eligibility Criteria
You may qualify if:
- or older
You may not qualify if:
- Visual impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fox Chase Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19012, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carolyn Heckman, PhD
- Organization
- Fox Chase Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Heckman, PhD
Fox Chase Cancer Center
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