NCT02437305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 3, 2016

Completed
Last Updated

January 27, 2017

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

April 16, 2015

Results QC Date

September 14, 2016

Last Update Submit

November 30, 2016

Conditions

Melanoma

Keywords

MelanomaPeople of Color

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 months post-intervention

  • 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.

    2 months post-intervention

Study Arms (2)

ABCDEs of Melanoma Skin Cancer

EXPERIMENTAL

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

ABCDEs of Melanoma

ACTIVE COMPARATOR

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

Behavioral: ABCDEs of Melanoma

Interventions

ABCDEs of Melanoma Skin CancerBEHAVIORAL

Modified melanoma educational intervention that is targeted towards people of color.

ABCDEs of Melanoma Skin Cancer
ABCDEs of MelanomaBEHAVIORAL

Conventional melanoma educational intervention.

ABCDEs of Melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

  • 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.

    PMID: 24485530BACKGROUND

  • 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.

    PMID: 17000949BACKGROUND

  • 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.

    PMID: 15061597BACKGROUND

  • 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.

    PMID: 20219266BACKGROUND

  • 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.

    PMID: 20878831BACKGROUND

  • 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.

    PMID: 28035649DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Roopal Kundu
Organization
Northwestern Univeristy
rkundu@nm.org
312-926-4926

Study Officials

  • Roopal V Kundu, M.D.

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Dermatology

Study Record Dates

First Submitted

April 16, 2015

First Posted

May 7, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 27, 2017

Results First Posted

November 3, 2016

Record last verified: 2016-11

Locations

US(1)