An interventional study of UV-Detect Photos and Motivational Interviewing in Skin Cancer Prevention, sponsored by Fox Chase Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-31.
Sponsored by Fox Chase Cancer Center · Not applicable, Interventional, and Prevention
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.
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.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 197 is above the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
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Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.
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Exclusion Criteria:
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
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
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
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 Photos · Behavioral: Motivational Interviewing
UV-Detect Photos
Motivational Interviewing
Education
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
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
| Milestone | Education Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing |
|---|---|---|---|---|
| Started | 48 | 44 | 58 | 47 |
| Completed | 39 | 30 | 48 | 37 |
| Not completed | 9 | 14 | 10 | 10 |
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).
| Participants | Education Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing |
|---|---|---|---|---|
| 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 |
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).
| Participants | Education Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing |
|---|---|---|---|---|
| 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 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Education Control | — | — | — |
| Motivational Interviewing | — | — | — |
| UV-detect Photos | — | — | — |
| UV-detect Photos and Motivational Interviewing | — | — | — |
| Age, Categorical(Participants) | Educational Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 44 | 58 | 47 | 197 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Educational Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing | Total |
|---|---|---|---|---|---|
| Mean | 20.29 ± 1.68 | 20.32 ± 1.41 | 20.43 ± 1.49 | 20.85 ± 1.67 | 20.47 ± 1.56 |
| Sex: Female, Male(Participants) | Educational Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing | Total |
|---|---|---|---|---|---|
| Female | 34 | 35 | 49 | 44 | 162 |
| Male | 14 | 9 | 9 | 3 | 35 |
| Race/Ethnicity, Customized(Participants) | Educational Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing | Total |
|---|---|---|---|---|---|
| African American/Black | 4 | 0 | 3 | 2 | 9 |
| Asian-American/Pacific Islander | 8 | 6 | 5 | 5 | 24 |
| Caucasian/White | 31 | 32 | 44 | 39 | 146 |
| Hispanic/Latino | 1 | 0 | 2 | 0 | 3 |
| Other/Mixed | 4 | 6 | 4 | 1 | 15 |
| Stage of Change Scale(Participants) | Educational Control | Motivational Interviewing | UV-detect Photos | UV-detect Photos and Motivational Interviewing | Total |
|---|---|---|---|---|---|
| Precontemplation | 17 | 15 | 24 | 15 | 71 |
| Contemplation | 5 | 4 | 4 | 4 | 17 |
| Preparation | 8 | 12 | 14 | 14 | 48 |
| Action | 5 | 3 | 6 | 2 | 16 |
| Maintenance | 13 | 10 | 9 | 10 | 42 |
| data missing | 0 | 0 | 1 | 2 | 3 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Fox Chase Cancer Center