Trial Outcomes & Findings for Melanoma Perception and Health Literacy in People of Color (NCT NCT02437305)
NCT ID: NCT02437305
Last Updated: 2017-01-27
Results Overview
The subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 5 questions will assess whether or not the patient has completed skin-self examinations and knows which areas of the skin to pay attention to. The pre-intervention and 2 month post-intervention questionnaire will be evaluated to determine the number of participants that performed regular self-skin examinations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
2 months post-intervention
Results posted on
2017-01-27
Participant Flow
Participants were consecutive patients seen for care at Northwestern Medicine's dermatology clinic in Chicago, IL between May and July 2015.
Participant milestones
| Measure |
ABCDEs of Melanoma Skin Cancer
A modified melanoma educational intervention that uses the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature "melanoma skin cancer"; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color.
|
ABCDEs of Melanoma
A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
32
|
38
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
Reasons for withdrawal
| Measure |
ABCDEs of Melanoma Skin Cancer
A modified melanoma educational intervention that uses the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature "melanoma skin cancer"; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color.
|
ABCDEs of Melanoma
A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
18
|
12
|
Baseline Characteristics
Melanoma Perception and Health Literacy in People of Color
Baseline characteristics by cohort
| Measure |
ABCDEs of Melanoma Skin Cancer
n=50 Participants
A modified melanoma educational intervention that uses the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature "melanoma skin cancer"; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color.
|
ABCDEs of Melanoma
n=50 Participants
A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-25
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Age, Customized
26-50
|
26 participants
n=99 Participants
|
29 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Age, Customized
51-75
|
21 participants
n=99 Participants
|
14 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Age, Customized
76+
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Gender
Female
|
42 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Gender
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
39 participants
n=99 Participants
|
39 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian and Alaskan Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Education
<12 years
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Education
High school
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Education
Some college/technical school
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Education
College graduate
|
14 participants
n=99 Participants
|
17 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Education
Graduate/professional
|
21 participants
n=99 Participants
|
17 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Personal history of skin cancer
Yes
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Personal history of skin cancer
No
|
49 participants
n=99 Participants
|
49 participants
n=107 Participants
|
98 participants
n=206 Participants
|
|
Family history of skin cancer
Yes
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Family history of skin cancer
No
|
49 participants
n=99 Participants
|
44 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Skin reaction to the sun
Always burn/never tan
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Skin reaction to the sun
Usually burn/rarely tan
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Skin reaction to the sun
Rarely burn/usually tan
|
18 participants
n=99 Participants
|
24 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Skin reaction to the sun
Never burn/always tan
|
17 participants
n=99 Participants
|
19 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Skin reaction to the sun
None of these
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 months post-interventionThe subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 5 questions will assess whether or not the patient has completed skin-self examinations and knows which areas of the skin to pay attention to. The pre-intervention and 2 month post-intervention questionnaire will be evaluated to determine the number of participants that performed regular self-skin examinations.
Outcome measures
| Measure |
ABCDEs of Melanoma Skin Cancer
n=32 Participants
A modified melanoma educational intervention that uses the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature "melanoma skin cancer"; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color.
|
ABCDEs of Melanoma
n=38 Participants
A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention.
|
|---|---|---|
|
Number of Participants That Performed Regular Self-Skin Examinations
Pre-I: perform skin self-exam
|
8 participants
|
16 participants
|
|
Number of Participants That Performed Regular Self-Skin Examinations
2MF: performed skin self-exam
|
23 participants
|
25 participants
|
PRIMARY outcome
Timeframe: 2 months post-interventionThe subject will complete 3 questionnaires: one pre-intervention, one post-intervention, and one 2 months post-intervention. Several questions will assess the participants knowledge of general melanoma, what it looks like and what are its risk factors. To determine participant retention, the pre-intervention and 2 month post-intervention questionnaires will be evaluated.
Outcome measures
| Measure |
ABCDEs of Melanoma Skin Cancer
n=32 Participants
A modified melanoma educational intervention that uses the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature "melanoma skin cancer"; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.
ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color.
|
ABCDEs of Melanoma
n=38 Participants
A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.
ABCDEs of Melanoma: Conventional melanoma educational intervention.
|
|---|---|---|
|
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
2MF: Knows the warning signs of melanoma
|
30 participants
|
33 participants
|
|
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
Pre-I: Melanoma is a type of skin cancer
|
27 participants
|
28 participants
|
|
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
2MF: Melanoma is a type of skin cancer
|
31 participants
|
36 participants
|
|
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
Pre-I: Sun exposure is linked to melanoma
|
23 participants
|
29 participants
|
|
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
2MF: Sun exposure is linked to melanoma
|
30 participants
|
36 participants
|
|
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
Pre-I: Knows the warning signs of melanoma
|
24 participants
|
23 participants
|
Adverse Events
ABCDEs of Melanoma Skin Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ABCDEs of Melanoma
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