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Melanoma Perception and Health Literacy in People of Color

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABCDEs of Melanoma Skin Cancer
ABCDEs of Melanoma
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma focused on measuring Melanoma, People of Color

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English-speaking
  • Self-identifies with one of the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic

Exclusion Criteria:

  • Not proficient in English
  • Unable to give informed consent
  • Does not self-identify with the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic

Sites / Locations

  • Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABCDEs of Melanoma Skin Cancer

ABCDEs of Melanoma

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of Participants That Performed Regular Self-Skin Examinations
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.
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2015
Last Updated
November 30, 2016
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02437305
Brief Title
Melanoma Perception and Health Literacy in People of Color
Official Title
Melanoma Perception and Health Literacy in People of Color: A Targeted Educational Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine the effectiveness of a targeted, health literate educational intervention for people of color compared to a standard melanoma education pamphlet for increasing knowledge and promoting early melanoma detection. It is hypothesized that people of color are less aware of their risk for developing melanoma and that a targeted educational intervention will help increase knowledge and promote early melanoma detection especially in individuals with low health literacy.
Detailed Description
This targeted educational intervention will compare a standard melanoma education pamphlet with one that has been modified to target people of color. Both pamphlets will include the ABCDEs of melanoma, risk factors, prevention and treatment. In addition, the targeted pamphlet will incorporate the recommendations made by people of color in previous studies. The pamphlets will be randomized to subjects at a study visit along with a health literacy test and a questionnaire aimed at determining subjects' baseline melanoma knowledge and current melanoma prevention practices. 2 months post-intervention, a follow-up phone call will be made to assess subject knowledge retention and behavior change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, People of Color

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABCDEs of Melanoma Skin Cancer
Arm Type
Experimental
Arm 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.
Arm Title
ABCDEs of Melanoma
Arm Type
Active Comparator
Arm Description
A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.
Intervention Type
Behavioral
Intervention Name(s)
ABCDEs of Melanoma Skin Cancer
Intervention Description
Modified melanoma educational intervention that is targeted towards people of color.
Intervention Type
Behavioral
Intervention Name(s)
ABCDEs of Melanoma
Intervention Description
Conventional melanoma educational intervention.
Primary Outcome Measure Information:
Title
Number of Participants That Performed Regular Self-Skin Examinations
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
Title
Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-speaking Self-identifies with one of the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic Exclusion Criteria: Not proficient in English Unable to give informed consent Does not self-identify with the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roopal V Kundu, M.D.
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24485530
Citation
Agbai ON, Buster K, Sanchez M, Hernandez C, Kundu RV, Chiu M, Roberts WE, Draelos ZD, Bhushan R, Taylor SC, Lim HW. Skin cancer and photoprotection in people of color: a review and recommendations for physicians and the public. J Am Acad Dermatol. 2014 Apr;70(4):748-762. doi: 10.1016/j.jaad.2013.11.038. Epub 2014 Jan 28.
Results Reference
background
PubMed Identifier
17000949
Citation
Cormier JN, Xing Y, Ding M, Lee JE, Mansfield PF, Gershenwald JE, Ross MI, Du XL. Ethnic differences among patients with cutaneous melanoma. Arch Intern Med. 2006 Sep 25;166(17):1907-14. doi: 10.1001/archinte.166.17.1907.
Results Reference
background
PubMed Identifier
15061597
Citation
Freeman HP. Poverty, culture, and social injustice: determinants of cancer disparities. CA Cancer J Clin. 2004 Mar-Apr;54(2):72-7. doi: 10.3322/canjclin.54.2.72. No abstract available.
Results Reference
background
PubMed Identifier
20219266
Citation
Kundu RV, Kamaria M, Ortiz S, West DP, Rademaker AW, Robinson JK. Effectiveness of a knowledge-based intervention for melanoma among those with ethnic skin. J Am Acad Dermatol. 2010 May;62(5):777-84. doi: 10.1016/j.jaad.2009.08.047. Epub 2010 Mar 9.
Results Reference
background
PubMed Identifier
20878831
Citation
Robinson JK, Joshi KM, Ortiz S, Kundu RV. Melanoma knowledge, perception, and awareness in ethnic minorities in Chicago: recommendations regarding education. Psychooncology. 2011 Mar;20(3):313-20. doi: 10.1002/pon.1736.
Results Reference
background
PubMed Identifier
28035649
Citation
Chao LX, Patterson SSL, Rademaker AW, Liu D, Kundu RV. Melanoma Perception in People of Color: A Targeted Educational Intervention. Am J Clin Dermatol. 2017 Jun;18(3):419-427. doi: 10.1007/s40257-016-0244-y.
Results Reference
derived

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Melanoma Perception and Health Literacy in People of Color

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