Melanoma Perception and Health Literacy in People of Color

Melanoma Clinical Trial

Official title:

Melanoma Perception and Health Literacy in People of Color: A Targeted Educational Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437305
• Other study ID #: STU00200459
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: March 16, 2016
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Melanoma

Intervention

Behavioral:
• ABCDEs of Melanoma Skin Cancer
Modified melanoma educational intervention that is targeted towards people of color.
• ABCDEs of Melanoma
Conventional melanoma educational intervention.

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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):748-62. doi: 10.1016/j.jaad.2013.11.038. Epub 2014 Jan 28. Review. — View 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. — View Citation

Freeman HP. Poverty, culture, and social injustice: determinants of cancer disparities. CA Cancer J Clin. 2004 Mar-Apr;54(2):72-7. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased regular self-skin examinations and full head-to-toe skin examinations at a physician's office	The subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 6 questions will assess whether or not the patient has completed skin-self examinations, knows which areas of the skin to pay attention to and whether or not the patient will see a physician for a skin exam.	2 months post-intervention	No
Primary	Melanoma knowledge retention	The questionnaires will also include 6 general melanoma questions that assess the subject's understanding of what melanoma is, what it looks like and what are its risk factors.	2 months post-intervention	No