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The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention

The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00709306
Enrollment
197
Registered
2008-07-03
Start date
2006-03-31
Completion date
2010-06-30
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer Prevention

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.

Detailed description

Teens and young adults are at high risk for overexposure to ultraviolet (UV) radiation, a leading factor in the development of skin cancer. The majority of these individuals continue to protect themselves minimally and tan intentionally, including significant increases in tanning booth use recently. Such care-free behaviors exist despite widespread education/awareness about UV radiation and skin cancer. 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. Therefore, the studies should provide useful information about process and outcome for skin cancer prevention researchers and clinicians.

Interventions

DEVICEUV-Detect Photos

UV-Detect Photos

BEHAVIORALMotivational Interviewing

Motivational Interviewing

BEHAVIORALEducation

Education

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fox Chase Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 or older

Exclusion criteria

* Visual impairment

Design outcomes

Primary

MeasureTime frameDescription
Sun Stage of Change at 3 Months3 monthsThe 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).
Sun Stage of Change at 12 Months12 monthsThe 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).

Countries

United States

Participant flow

Pre-assignment details

Participants were consented, baselined, and randomized upon arrival to the in-person session, thus no enrolled participants were excluded from the study before assignment to one of the four treatment conditions.

Participants by arm

ArmCount
Educational Control
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.
48
Motivational Interviewing
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.
44
UV-detect Photos
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.
58
UV-detect Photos and Motivational Interviewing
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.
47
Total197

Baseline characteristics

CharacteristicEducational ControlMotivational InterviewingUV-detect PhotosUV-detect Photos and Motivational InterviewingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
48 Participants44 Participants58 Participants47 Participants197 Participants
Age, Continuous20.29 years
STANDARD_DEVIATION 1.68
20.32 years
STANDARD_DEVIATION 1.41
20.43 years
STANDARD_DEVIATION 1.49
20.85 years
STANDARD_DEVIATION 1.67
20.47 years
STANDARD_DEVIATION 1.56
Race/Ethnicity, Customized
African American/Black
4 Participants0 Participants3 Participants2 Participants9 Participants
Race/Ethnicity, Customized
Asian-American/Pacific Islander
8 Participants6 Participants5 Participants5 Participants24 Participants
Race/Ethnicity, Customized
Caucasian/White
31 Participants32 Participants44 Participants39 Participants146 Participants
Race/Ethnicity, Customized
Hispanic/Latino
1 Participants0 Participants2 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Other/Mixed
4 Participants6 Participants4 Participants1 Participants15 Participants
Sex: Female, Male
Female
34 Participants35 Participants49 Participants44 Participants162 Participants
Sex: Female, Male
Male
14 Participants9 Participants9 Participants3 Participants35 Participants
Stage of Change Scale
Action
5 Participants3 Participants6 Participants2 Participants16 Participants
Stage of Change Scale
Contemplation
5 Participants4 Participants4 Participants4 Participants17 Participants
Stage of Change Scale
data missing
0 Participants0 Participants1 Participants2 Participants3 Participants
Stage of Change Scale
Maintenance
13 Participants10 Participants9 Participants10 Participants42 Participants
Stage of Change Scale
Precontemplation
17 Participants15 Participants24 Participants15 Participants71 Participants
Stage of Change Scale
Preparation
8 Participants12 Participants14 Participants14 Participants48 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

Primary

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).

Time frame: 12 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Education ControlSun Stage of Change at 12 MonthsContemplation2 Participants
Education ControlSun Stage of Change at 12 MonthsPrecontemplation10 Participants
Education ControlSun Stage of Change at 12 MonthsPreparation7 Participants
Education ControlSun Stage of Change at 12 MonthsMaintenance14 Participants
Education ControlSun Stage of Change at 12 MonthsAction6 Participants
Motivational InterviewingSun Stage of Change at 12 MonthsMaintenance15 Participants
Motivational InterviewingSun Stage of Change at 12 MonthsPrecontemplation4 Participants
Motivational InterviewingSun Stage of Change at 12 MonthsContemplation3 Participants
Motivational InterviewingSun Stage of Change at 12 MonthsPreparation5 Participants
Motivational InterviewingSun Stage of Change at 12 MonthsAction3 Participants
UV-detect PhotosSun Stage of Change at 12 MonthsContemplation2 Participants
UV-detect PhotosSun Stage of Change at 12 MonthsPreparation11 Participants
UV-detect PhotosSun Stage of Change at 12 MonthsAction7 Participants
UV-detect PhotosSun Stage of Change at 12 MonthsPrecontemplation11 Participants
UV-detect PhotosSun Stage of Change at 12 MonthsMaintenance17 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 12 MonthsContemplation0 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 12 MonthsAction5 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 12 MonthsPreparation20 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 12 MonthsPrecontemplation7 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 12 MonthsMaintenance5 Participants
Primary

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).

Time frame: 3 months

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Education ControlSun Stage of Change at 3 MonthsPreparation7 Participants
Education ControlSun Stage of Change at 3 MonthsMaintenance15 Participants
Education ControlSun Stage of Change at 3 MonthsPrecontemplation17 Participants
Education ControlSun Stage of Change at 3 MonthsAction3 Participants
Education ControlSun Stage of Change at 3 MonthsContemplation2 Participants
Motivational InterviewingSun Stage of Change at 3 MonthsPreparation15 Participants
Motivational InterviewingSun Stage of Change at 3 MonthsContemplation1 Participants
Motivational InterviewingSun Stage of Change at 3 MonthsMaintenance10 Participants
Motivational InterviewingSun Stage of Change at 3 MonthsPrecontemplation5 Participants
Motivational InterviewingSun Stage of Change at 3 MonthsAction7 Participants
UV-detect PhotosSun Stage of Change at 3 MonthsContemplation3 Participants
UV-detect PhotosSun Stage of Change at 3 MonthsMaintenance14 Participants
UV-detect PhotosSun Stage of Change at 3 MonthsAction8 Participants
UV-detect PhotosSun Stage of Change at 3 MonthsPreparation15 Participants
UV-detect PhotosSun Stage of Change at 3 MonthsPrecontemplation10 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 3 MonthsMaintenance10 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 3 MonthsPrecontemplation12 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 3 MonthsContemplation2 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 3 MonthsPreparation15 Participants
UV-detect Photos and Motivational InterviewingSun Stage of Change at 3 MonthsAction4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026