Trial Outcomes & Findings for Skin Self-Examination Education During Mammography (NCT NCT03512457)
NCT ID: NCT03512457
Last Updated: 2021-04-13
Results Overview
The percentage of participants that performed skin self-examination at the 3-month time interval.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
420 participants
Primary outcome timeframe
3-months
Results posted on
2021-04-13
Participant Flow
Participant milestones
| Measure |
Intensive Intervention
Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.
Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure.
|
Minimal Intervention
Participants receive brochure, card advising how to make an appointment with dermatology.
Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure.
|
|---|---|---|
|
Overall Study
STARTED
|
195
|
225
|
|
Overall Study
COMPLETED
|
161
|
185
|
|
Overall Study
NOT COMPLETED
|
34
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Skin Self-Examination Education During Mammography
Baseline characteristics by cohort
| Measure |
Intensive Intervention
n=195 Participants
Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.
Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure.
|
Minimal Intervention
n=225 Participants
Participants receive brochure, card advising how to make an appointment with dermatology.
Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
53.1 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
52.4 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=99 Participants
|
225 Participants
n=107 Participants
|
420 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
173 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
383 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
302 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
195 Participants
n=99 Participants
|
225 Participants
n=107 Participants
|
420 Participants
n=206 Participants
|
|
Number of participants who had ever conducted skin self-examination prior to study participation
|
55 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3-monthsPopulation: Women performing skin self-examination as reported 3 months after the intervention
The percentage of participants that performed skin self-examination at the 3-month time interval.
Outcome measures
| Measure |
Intensive Intervention
n=195 Participants
Women who received an educational brochure and a 1-week reminder call or email to complete SSE
|
Educational Intervention
n=225 Participants
Women who only received a brochure.
|
|---|---|---|
|
Number of Participants That Performed a Skin Self-Examination at 3-months
|
161 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: 7-monthsPopulation: Women who found a concerning mole at month 1 and month 3 and proceeded to have a skin examination by a dermatologist
The total number of melanomas identified by a dermatologist in women who found a concerning mole
Outcome measures
| Measure |
Intensive Intervention
n=20 Participants
Women who received an educational brochure and a 1-week reminder call or email to complete SSE
|
Educational Intervention
n=23 Participants
Women who only received a brochure.
|
|---|---|---|
|
Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion
|
2 Melanomas
|
5 Melanomas
|
Adverse Events
Intensive Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Minimal Intervention
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