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Melanoma Perception and Health Literacy in People of Color

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ClinicalTrials.gov Identifier: NCT02437305
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : November 3, 2016
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Roopal Kundu, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Melanoma
Interventions Behavioral: ABCDEs of Melanoma Skin Cancer
Behavioral: ABCDEs of Melanoma
Enrollment 100
Recruitment Details Participants were consecutive patients seen for care at Northwestern Medicine's dermatology clinic in Chicago, IL between May and July 2015.
Pre-assignment Details  
Arm/Group Title ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma
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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.

A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.

ABCDEs of Melanoma: Conventional melanoma educational intervention.

Period Title: Overall Study
Started 50 50
Completed 32 38
Not Completed 18 12
Reason Not Completed
Lost to Follow-up             18             12
Arm/Group Title ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma Total
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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.

A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.

ABCDEs of Melanoma: Conventional melanoma educational intervention.

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
18-25 3 5 8
26-50 26 29 55
51-75 21 14 35
76+ 0 2 2
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
42
  84.0%
43
  86.0%
85
  85.0%
Male
8
  16.0%
7
  14.0%
15
  15.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
African American 39 39 78
Asian/Pacific Islander 5 6 11
American Indian and Alaskan Native 0 0 0
Hispanic 6 5 11
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<12 years 1 1 2
High school 2 4 6
Some college/technical school 12 11 23
College graduate 14 17 31
Graduate/professional 21 17 38
Personal history of skin cancer  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Yes 1 1 2
No 49 49 98
Family history of skin cancer  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Yes 1 6 7
No 49 44 93
Skin reaction to the sun  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Always burn/never tan 3 1 4
Usually burn/rarely tan 3 1 4
Rarely burn/usually tan 18 24 42
Never burn/always tan 17 19 36
None of these 9 5 14
1.Primary Outcome
Title Number of Participants That Performed Regular Self-Skin Examinations
Hide Description 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.
Time Frame 2 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma
Hide Arm/Group Description:

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.

A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.

ABCDEs of Melanoma: Conventional melanoma educational intervention.

Overall Number of Participants Analyzed 32 38
Measure Type: Number
Unit of Measure: participants
Pre-I: perform skin self-exam 8 16
2MF: performed skin self-exam 23 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABCDEs of Melanoma Skin Cancer, ABCDEs of Melanoma
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments P-value compares the increase in skin self-exams from pre-intervention to 2-months follow-up between the 2 groups.
Method McNemar
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
Hide Description The 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.
Time Frame 2 months post-intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma
Hide Arm/Group Description:

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.

A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.

ABCDEs of Melanoma: Conventional melanoma educational intervention.

Overall Number of Participants Analyzed 32 38
Measure Type: Number
Unit of Measure: participants
Pre-I: Melanoma is a type of skin cancer 27 28
2MF: Melanoma is a type of skin cancer 31 36
Pre-I: Sun exposure is linked to melanoma 23 29
2MF: Sun exposure is linked to melanoma 30 36
Pre-I: Knows the warning signs of melanoma 24 23
2MF: Knows the warning signs of melanoma 30 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABCDEs of Melanoma Skin Cancer, ABCDEs of Melanoma
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.50
Comments P-value compares the increase in knowledge from pre-intervention to 2-months follow-up between the 2 groups.
Method McNemar
Comments [Not Specified]
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma
Hide Arm/Group Description

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.

A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.

ABCDEs of Melanoma: Conventional melanoma educational intervention.

All-Cause Mortality
ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ABCDEs of Melanoma Skin Cancer ABCDEs of Melanoma
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Small sample size and high dropout rate; recruitment from dermatology clinic patients with a majority having college degrees or higher so the study results are less generalizable.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Roopal Kundu
Organization: Northwestern Univeristy
Phone: 312-926-4926
EMail: rkundu@nm.org
Responsible Party: Roopal Kundu, Northwestern University
ClinicalTrials.gov Identifier: NCT02437305     History of Changes
Other Study ID Numbers: STU00200459
First Submitted: April 16, 2015
First Posted: May 7, 2015
Results First Submitted: September 14, 2016
Results First Posted: November 3, 2016
Last Update Posted: January 27, 2017