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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

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.

Condition or disease Intervention/treatment Phase
Melanoma Behavioral: ABCDEs of Melanoma Skin Cancer Behavioral: ABCDEs of Melanoma Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Melanoma Perception and Health Literacy in People of Color: A Targeted Educational Intervention
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Behavioral: ABCDEs of Melanoma Skin Cancer
Modified melanoma educational intervention that is targeted towards people of color.
Active Comparator: ABCDEs of Melanoma
A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation.
Behavioral: ABCDEs of Melanoma
Conventional melanoma educational intervention.



Primary Outcome Measures :
  1. Number of Participants That Performed Regular Self-Skin Examinations [ Time Frame: 2 months post-intervention ]
    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.

  2. Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437305


Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Roopal V Kundu, M.D. Northwestern University Feinberg School of Medicine

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roopal Kundu, Associate Professor in Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT02437305     History of Changes
Other Study ID Numbers: STU00200459
First Posted: May 7, 2015    Key Record Dates
Results First Posted: November 3, 2016
Last Update Posted: January 27, 2017
Last Verified: November 2016

Keywords provided by Roopal Kundu, Northwestern University:
Melanoma
People of Color

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas