Trial Outcomes & Findings for Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma (NCT NCT03028948)
NCT ID: NCT03028948
Last Updated: 2026-01-14
Results Overview
Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
COMPLETED
NA
485 participants
At 24 weeks
2026-01-14
Participant Flow
Of 485 consented participants, 441 completed baseline survey and were randomized to treatment.
Participant milestones
| Measure |
mySmartSkin
Of 485 enrolled individuals, 224 were randomized to MSS.
These individuals access MSS content and complete the three educational Cores. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.
|
Usual Care
Of the 485 enrolled individuals, 217 were randomized to the UC condition.
These participants received the usual clinical follow-up care. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.
|
|---|---|---|
|
8 Week Follow-up
STARTED
|
224
|
217
|
|
8 Week Follow-up
COMPLETED
|
198
|
215
|
|
8 Week Follow-up
NOT COMPLETED
|
26
|
2
|
|
24 Week Follow-up
STARTED
|
224
|
217
|
|
24 Week Follow-up
COMPLETED
|
189
|
207
|
|
24 Week Follow-up
NOT COMPLETED
|
35
|
10
|
|
48 Week Follow-up
STARTED
|
224
|
217
|
|
48 Week Follow-up
COMPLETED
|
180
|
202
|
|
48 Week Follow-up
NOT COMPLETED
|
44
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma
Baseline characteristics by cohort
| Measure |
mySmartSkin
n=224 Participants
Of 485 enrolled individuals, 224 were randomized to MSS.
These individuals access MSS content and complete the three educational Cores. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.
|
Usual Care
n=217 Participants
Of the 485 enrolled individuals, 217 were randomized to the UC condition.
These participants received the usual clinical follow-up care. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 12.9 • n=14 Participants
|
60.8 years
STANDARD_DEVIATION 13.7 • n=10 Participants
|
61.4 years
STANDARD_DEVIATION 13.3 • n=24 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=14 Participants
|
113 Participants
n=10 Participants
|
216 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=14 Participants
|
104 Participants
n=10 Participants
|
225 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
218 Participants
n=14 Participants
|
214 Participants
n=10 Participants
|
432 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Other
|
2 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=24 Participants
|
|
Level of Education
≤ High school graduate
|
32 Participants
n=14 Participants
|
22 Participants
n=10 Participants
|
54 Participants
n=24 Participants
|
|
Level of Education
Some college
|
42 Participants
n=14 Participants
|
45 Participants
n=10 Participants
|
87 Participants
n=24 Participants
|
|
Level of Education
College graduate
|
70 Participants
n=14 Participants
|
63 Participants
n=10 Participants
|
133 Participants
n=24 Participants
|
|
Level of Education
Graduate degree
|
80 Participants
n=14 Participants
|
87 Participants
n=10 Participants
|
167 Participants
n=24 Participants
|
|
Annual Household Income
≤ $59,999
|
37 Participants
n=14 Participants
|
26 Participants
n=10 Participants
|
63 Participants
n=24 Participants
|
|
Annual Household Income
$60,000 to $99,999
|
56 Participants
n=14 Participants
|
53 Participants
n=10 Participants
|
109 Participants
n=24 Participants
|
|
Annual Household Income
$100,000 to $149,999
|
45 Participants
n=14 Participants
|
39 Participants
n=10 Participants
|
84 Participants
n=24 Participants
|
|
Annual Household Income
≥ $150,000
|
68 Participants
n=14 Participants
|
68 Participants
n=10 Participants
|
136 Participants
n=24 Participants
|
|
Annual Household Income
Unknown
|
18 Participants
n=14 Participants
|
31 Participants
n=10 Participants
|
49 Participants
n=24 Participants
|
|
Marital Status
Married/partnered
|
179 Participants
n=14 Participants
|
172 Participants
n=10 Participants
|
351 Participants
n=24 Participants
|
|
Marital Status
Not married/partnered
|
45 Participants
n=14 Participants
|
45 Participants
n=10 Participants
|
90 Participants
n=24 Participants
|
|
Frequency of using the Internet
2 or fewer days/week
|
13 Participants
n=14 Participants
|
13 Participants
n=10 Participants
|
26 Participants
n=24 Participants
|
|
Frequency of using the Internet
3 to 5 days/week
|
13 Participants
n=14 Participants
|
12 Participants
n=10 Participants
|
25 Participants
n=24 Participants
|
|
Frequency of using the Internet
Once a day
|
40 Participants
n=14 Participants
|
23 Participants
n=10 Participants
|
63 Participants
n=24 Participants
|
|
Frequency of using the Internet
2 to 3 times/day
|
53 Participants
n=14 Participants
|
65 Participants
n=10 Participants
|
118 Participants
n=24 Participants
|
|
Frequency of using the Internet
4 or more times/day
|
98 Participants
n=14 Participants
|
101 Participants
n=10 Participants
|
199 Participants
n=24 Participants
|
|
Frequency of using the Internet
Unknown
|
7 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
10 Participants
n=24 Participants
|
|
Level of comfort using the Internet
Very uncomfortable
|
10 Participants
n=14 Participants
|
9 Participants
n=10 Participants
|
19 Participants
n=24 Participants
|
|
Level of comfort using the Internet
Somewhat uncomfortable
|
15 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
23 Participants
n=24 Participants
|
|
Level of comfort using the Internet
Neither comfortable nor uncomfortable
|
16 Participants
n=14 Participants
|
11 Participants
n=10 Participants
|
27 Participants
n=24 Participants
|
|
Level of comfort using the Internet
Somewhat comfortable
|
50 Participants
n=14 Participants
|
49 Participants
n=10 Participants
|
99 Participants
n=24 Participants
|
|
Level of comfort using the Internet
Very comfortable
|
126 Participants
n=14 Participants
|
137 Participants
n=10 Participants
|
263 Participants
n=24 Participants
|
|
Level of comfort using the Internet
Unknown
|
7 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
10 Participants
n=24 Participants
|
|
Number of melanoma risk factors (range 0-8)
|
4.3 risk factors
STANDARD_DEVIATION 1.7 • n=14 Participants
|
4.4 risk factors
STANDARD_DEVIATION 1.6 • n=10 Participants
|
4.4 risk factors
STANDARD_DEVIATION 1.6 • n=24 Participants
|
|
Time since melanoma surgery
3 to < 14 months
|
108 Participants
n=14 Participants
|
116 Participants
n=10 Participants
|
224 Participants
n=24 Participants
|
|
Time since melanoma surgery
14 to 24 months
|
116 Participants
n=14 Participants
|
101 Participants
n=10 Participants
|
217 Participants
n=24 Participants
|
|
Disease stage
0
|
67 Participants
n=14 Participants
|
69 Participants
n=10 Participants
|
136 Participants
n=24 Participants
|
|
Disease stage
I
|
126 Participants
n=14 Participants
|
119 Participants
n=10 Participants
|
245 Participants
n=24 Participants
|
|
Disease stage
II
|
18 Participants
n=14 Participants
|
16 Participants
n=10 Participants
|
34 Participants
n=24 Participants
|
|
Disease stage
III
|
13 Participants
n=14 Participants
|
13 Participants
n=10 Participants
|
26 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At 24 weeksParticipants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Outcome measures
| Measure |
mySmartSkin
n=189 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
n=207 Participants
Did not complete.
|
|---|---|---|
|
Sun Protection Behavior Index
|
3.54 scores on a scale
Standard Deviation 0.74
|
3.37 scores on a scale
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: 8 weeksDefined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.
Outcome measures
| Measure |
mySmartSkin
n=198 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
n=215 Participants
Did not complete.
|
|---|---|---|
|
Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months
Yes
|
59 Participants
|
16 Participants
|
|
Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months
No
|
139 Participants
|
199 Participants
|
SECONDARY outcome
Timeframe: At 24 weeksDefined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months
Outcome measures
| Measure |
mySmartSkin
n=189 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
n=207 Participants
Did not complete.
|
|---|---|---|
|
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
Yes
|
54 Participants
|
24 Participants
|
|
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
No
|
132 Participants
|
182 Participants
|
|
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
Unknown
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 48 weeksDefined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
Outcome measures
| Measure |
mySmartSkin
n=180 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
n=202 Participants
Did not complete.
|
|---|---|---|
|
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
Unknown
|
5 Participants
|
7 Participants
|
|
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
Yes
|
54 Participants
|
26 Participants
|
|
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
No
|
121 Participants
|
169 Participants
|
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksTotal number of SSEs performed (regardless of their thoroughness)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksTotal number of body areas examined during the most recent SSE in the last 2 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksUse of a mirror, having someone else help, or using a body mole map during the most recent SSE
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksFrequency (from 1 = never to 5 = always) of wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksTotal number of sunburns received
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksFrequency (from 1 = never to 5 = always) of wearing long pants
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksFrequency (from 1 = never to 5 = always) of wearing sunglasses
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 8, 24 and 48 weeksFrequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineParticipants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Outcome measures
| Measure |
mySmartSkin
n=224 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
n=217 Participants
Did not complete.
|
|---|---|---|
|
Sun Protection Behavior Index
|
3.25 scores on a scale
Standard Deviation .75
|
3.29 scores on a scale
Standard Deviation .76
|
SECONDARY outcome
Timeframe: At 8 weeksParticipants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Outcome measures
| Measure |
mySmartSkin
n=198 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
n=215 Participants
Did not complete.
|
|---|---|---|
|
Sun Protection Behavior Index
|
3.4 scores on a scale
Standard Deviation .78
|
3.31 scores on a scale
Standard Deviation .81
|
SECONDARY outcome
Timeframe: At 48 weeksParticipants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Outcome measures
| Measure |
mySmartSkin
n=179 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
n=202 Participants
Did not complete.
|
|---|---|---|
|
Sun Protection Behavior Index
|
3.65 scores on a scale
Standard Deviation .72
|
3.52 scores on a scale
Standard Deviation .79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8, 24 and 48 weeksLevel of distress (from 1 = not at all distressed to 10 = extremely distressed)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8, 24 and 48 weeksMean rating of four questions regarding worry about melanoma recurrence
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8, 24 and 48 weeksMean rating of four questions regarding perceived risk of melanoma recurrence
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 48 weeksNumber of biopsies conducted
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 48 weeksNumber of times indoor tanned in the past year
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 48 weeksWhether a new or recurrent skin cancer was diagnosed
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 48 weeksIneligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8, 24 and 48 weeksReceipt of a physician skin examination and the reason for the visit
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8 weeksPopulation: This survey was only conducted among those who were randomized to MSS
Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.
Outcome measures
| Measure |
mySmartSkin
n=198 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
Did not complete.
|
|---|---|---|
|
Impact and Effectiveness of the Interactive Tailored Website
|
4.1 scores on scale
Standard Deviation 0.72
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8, 24 and 48 weeksNumber of visits to the website, the number of monthly skin self-checks completed, the number of updates to the sun-safe action plan, and starting/completing the remaining sections of the website (Introduction; Getting Ready to Do a Skin Self-Check; Practice Sun-Safe Behaviors).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 8 weeksPopulation: Only the participants randomized to the intervention arm completed this survey
Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.
Outcome measures
| Measure |
mySmartSkin
n=198 Participants
At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).
|
Usual Care
Did not complete.
|
|---|---|---|
|
Evaluation and Utility of the Interactive Tailored Website
|
4.3 scores on a scale
Standard Deviation 0.65
|
—
|
Adverse Events
mySmartSkin
Usual Care
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