Skin Cancer PreventionNCT00709306

The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention

A study testing UV-Detect Photos, Motivational Interviewing and Education in people with Skin Cancer Prevention, run by Fox Chase Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Skin Cancer Prevention
What is being tested?: UV-Detect Photos, Motivational Interviewing and Education
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 197 participants
Where: 1 siteUnited States
Study dates: Mar 2006to Jun 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18 or older

Who cannot join

Visual impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19012

Other trials in United States

About this study

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.

Read the 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.

Conditions: Skin Cancer Prevention
Being tested: UV-Detect Photos, Motivational Interviewing, Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UV-Detect PhotosDevice
UV-Detect Photos
Motivational InterviewingBehavioural
Motivational Interviewing
EducationBehavioural
Education

Study groups in NCT00709306
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: UV-Detect Photos; Behavioral: Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Jun 2010

First posted3 Jul 2008 (estimated)
Study startMar 2006
Primary completionJun 2008
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin Cancer PreventionStudies of the same condition, open and under way.
More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00709306
Sponsor's protocol ID: K07CA108685
Other IDs: K07CA108685
Status last verified: Jul 2018
First submitted: 1 Jul 2008
Last updated: 31 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Skin Cancer Prevention trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention
ClinicalTrials.gov ID: NCT00709306
Acronym / sponsor ID: K07CA108685
Conditions: Skin Cancer Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Fox Chase Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Mar 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2010 (actual)
First posted: 3 Jul 2008 (estimated)
Results: Posted 22 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Education	Placebo comparator	Behavioral: EducationParticipants 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 comparator	Behavioral: Motivational InterviewingParticipants 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 comparator	Device: UV-Detect PhotosParticipants 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	Experimental	Device: UV-Detect Photos, Behavioral: Motivational InterviewingParticipants 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.

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

18 or older

Key exclusion criteria (1 listed)

Visual impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UV-Detect PhotosUV-Detect Photos	Device	UV-detect photos, UV-detect photos & MI
Motivational InterviewingMotivational Interviewing	Behavioural	Motivational Interviewing, UV-detect photos & MI
EducationEducation	Behavioural	Education

Primary outcome

Sun Stage of Change at 3 Months
Time frame: 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).
Sun Stage of Change at 12 Months
Time frame: 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).

Results and safety

Results posted to the registry on 22 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Education Control	48	39
Motivational Interviewing	44	30
UV-detect Photos	58	48
UV-detect Photos and Motivational Interviewing	47	37

Primary outcome: Sun Stage of Change at 3 Months

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Education Control n = 44	Motivational Interviewing n = 38	UV-detect Photos n = 50	UV-detect Photos and Motivational Interviewing n = 43
Precontemplation	17	5	10	12
Contemplation	2	1	3	2
Preparation	7	15	15	15
Action	3	7	8	4
Maintenance	15	10	14	10

Primary outcome: Sun Stage of Change at 12 Months

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Education Control n = 39	Motivational Interviewing n = 30	UV-detect Photos n = 48	UV-detect Photos and Motivational Interviewing n = 37
Precontemplation	10	4	11	7
Contemplation	2	3	2	0
Preparation	7	5	11	20
Action	6	3	7	5
Maintenance	14	15	17	5

Adverse events

Time frame: Because this protocol involves low risk assessments and interventions (e.g., survey, brochure, UV picture, MI counseling, spectrophotometry), adverse event data were not collected. Because discussing cancer risk and looking at photos of UV damage may be upsetting, participants were monitored for distress at the time of baseline/intervention and any participants, however, no participants exhibited undue anxiety or concern during their participation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Education Control	0 of 0	0 of 0	Not reported
Motivational Interviewing	0 of 0	0 of 0	Not reported
UV-detect Photos	0 of 0	0 of 0	Not reported
UV-detect Photos and Motivational Interviewing	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Skin Cancer Prevention

Not yet recruitingPhase 2
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Breast Cancer
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
Not yet recruitingObservational study
An Overview of Vaccination Coverage Among Patients Receiving Treatment for Breast Cancer at the ICO: Identifying Factors Associated With Vaccination Uptake and Improved Prevention
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carolyn Heckman, PhD principal investigator

Fox Chase Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing UV-Detect Photos, Motivational Interviewing and Education in people with Skin Cancer Prevention, run by Fox Chase Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sun Stage of Change at 3 Months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00709306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.