Trial Outcomes & Findings for The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention (NCT NCT00709306)
NCT ID: NCT00709306
Last Updated: 2018-08-31
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
3 months
Results posted on
2018-08-31
Participant Flow
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.
Participant milestones
| Measure |
Education 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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
44
|
58
|
47
|
|
Overall Study
COMPLETED
|
39
|
30
|
48
|
37
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Skin Savvy Study: A Behavioral Skin Cancer Prevention Intervention
Baseline characteristics by cohort
| Measure |
Educational Control
n=48 Participants
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.
|
Motivational Interviewing
n=44 Participants
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.
|
UV-detect Photos
n=58 Participants
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.
|
UV-detect Photos and Motivational Interviewing
n=47 Participants
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.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
197 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
20.29 years
STANDARD_DEVIATION 1.68 • n=5 Participants
|
20.32 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
20.43 years
STANDARD_DEVIATION 1.49 • n=5 Participants
|
20.85 years
STANDARD_DEVIATION 1.67 • n=4 Participants
|
20.47 years
STANDARD_DEVIATION 1.56 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian-American/Pacific Islander
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Stage of Change Scale
Precontemplation
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Stage of Change Scale
Contemplation
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Stage of Change Scale
Preparation
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Stage of Change Scale
Action
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Stage of Change Scale
Maintenance
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Stage of Change Scale
data missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 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).
Outcome measures
| Measure |
Education Control
n=44 Participants
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.
|
Motivational Interviewing
n=38 Participants
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.
|
UV-detect Photos
n=50 Participants
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.
|
UV-detect Photos and Motivational Interviewing
n=43 Participants
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.
|
|---|---|---|---|---|
|
Sun Stage of Change at 3 Months
Precontemplation
|
17 Participants
|
5 Participants
|
10 Participants
|
12 Participants
|
|
Sun Stage of Change at 3 Months
Contemplation
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Sun Stage of Change at 3 Months
Preparation
|
7 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Sun Stage of Change at 3 Months
Action
|
3 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Sun Stage of Change at 3 Months
Maintenance
|
15 Participants
|
10 Participants
|
14 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 12 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).
Outcome measures
| Measure |
Education Control
n=39 Participants
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.
|
Motivational Interviewing
n=30 Participants
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.
|
UV-detect Photos
n=48 Participants
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.
|
UV-detect Photos and Motivational Interviewing
n=37 Participants
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.
|
|---|---|---|---|---|
|
Sun Stage of Change at 12 Months
Maintenance
|
14 Participants
|
15 Participants
|
17 Participants
|
5 Participants
|
|
Sun Stage of Change at 12 Months
Precontemplation
|
10 Participants
|
4 Participants
|
11 Participants
|
7 Participants
|
|
Sun Stage of Change at 12 Months
Contemplation
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Sun Stage of Change at 12 Months
Preparation
|
7 Participants
|
5 Participants
|
11 Participants
|
20 Participants
|
|
Sun Stage of Change at 12 Months
Action
|
6 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
Education Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Interviewing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UV-detect Photos
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UV-detect Photos and Motivational Interviewing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place