Trial Outcomes & Findings for Partner Assistance in Learning and Performing Skin Self-Examination (NCT NCT01013844)
NCT ID: NCT01013844
Last Updated: 2014-10-02
Results Overview
Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
4 months
Results posted on
2014-10-02
Participant Flow
Participants were recruited from hospital registries of patients who were diagnosed as having cutaneous melanoma (CM) and were being seen at least annually by physicians for their skin conditions.
Participant milestones
| Measure |
Solo Learning
Participant learning alone (without partner).
|
Dyadic Learning
Participant and partner learning together.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partner Assistance in Learning and Performing Skin Self-Examination
Baseline characteristics by cohort
| Measure |
Solo Learning
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning
n=65 Participants
Participant and partner learning together.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age, Customized
Between 18 and 69 years
|
54 participants
n=99 Participants
|
61 participants
n=107 Participants
|
115 participants
n=206 Participants
|
|
Age, Customized
>=70 years
|
11 participants
n=99 Participants
|
4 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=99 Participants
|
65 participants
n=107 Participants
|
130 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 monthsBehavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.
Outcome measures
| Measure |
Solo Learning Baseline
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning Baseline
n=65 Participants
Participant and partner learning together.
|
Solo Learning Immediate Follow-up
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning Immediate Follow-up
n=65 Participants
Participant and partner learning together.
|
Solo Learning 4-Month Follow-up
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning 4-Month Follow-up
n=65 Participants
Participant and partner learning together.
|
|---|---|---|---|---|---|---|
|
Mean Number of Skin Examinations Without Partner Over 4 Months
|
0.02 Times examined skin by self
Standard Deviation 0.12
|
0.00 Times examined skin by self
Standard Deviation 0.00
|
0.02 Times examined skin by self
Standard Deviation 0.12
|
0.00 Times examined skin by self
Standard Deviation 0.00
|
0.23 Times examined skin by self
Standard Deviation 0.42
|
0.80 Times examined skin by self
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: 4 monthsBehavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.
Outcome measures
| Measure |
Solo Learning Baseline
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning Baseline
n=65 Participants
Participant and partner learning together.
|
Solo Learning Immediate Follow-up
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning Immediate Follow-up
n=65 Participants
Participant and partner learning together.
|
Solo Learning 4-Month Follow-up
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning 4-Month Follow-up
n=65 Participants
Participant and partner learning together.
|
|---|---|---|---|---|---|---|
|
Mean Number of Skin Examinations With Partner Over 4 Months
|
0.0 Times examined skin with a partner
Standard Deviation 0.0
|
0.0 Times examined skin with a partner
Standard Deviation 0.0
|
0.0 Times examined skin with a partner
Standard Deviation 0.0
|
0.0 Times examined skin with a partner
Standard Deviation 0.0
|
0.23 Times examined skin with a partner
Standard Deviation 0.42
|
0.81 Times examined skin with a partner
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: 4 monthsBehavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.
Outcome measures
| Measure |
Solo Learning Baseline
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning Baseline
n=65 Participants
Participant and partner learning together.
|
Solo Learning Immediate Follow-up
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning Immediate Follow-up
n=65 Participants
Participant and partner learning together.
|
Solo Learning 4-Month Follow-up
n=65 Participants
Participant learning alone (without partner).
|
Dyadic Learning 4-Month Follow-up
n=65 Participants
Participant and partner learning together.
|
|---|---|---|---|---|---|---|
|
Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months
|
.03 Number of times reviewed SSE guidelines
Standard Deviation 0.17
|
0.0 Number of times reviewed SSE guidelines
Standard Deviation 0.0
|
0.08 Number of times reviewed SSE guidelines
Standard Deviation 0.27
|
0.0 Number of times reviewed SSE guidelines
Standard Deviation 0.0
|
0.55 Number of times reviewed SSE guidelines
Standard Deviation 0.53
|
0.91 Number of times reviewed SSE guidelines
Standard Deviation 0.68
|
Adverse Events
Solo Learning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dyadic Learning
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
June Robinson, MD
Northwestern University Department of Dermatology
Phone: 312-695-6624
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place