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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| ABCDEs of Melanoma | Active Comparator | A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABCDEs of Melanoma Skin Cancer | Behavioral | Modified melanoma educational intervention that is targeted towards people of color. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roopal V Kundu, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24485530 | Background | 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. | |
| 17000949 |
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Participants were consecutive patients seen for care at Northwestern Medicine's dermatology clinic in Chicago, IL between May and July 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color. |
| FG001 | ABCDEs of Melanoma | A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation. ABCDEs of Melanoma: Conventional melanoma educational intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 2 months post-intervention |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roopal Kundu | Northwestern Univeristy | 312-926-4926 | rkundu@nm.org |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ABCDEs of Melanoma | Behavioral | Conventional melanoma educational intervention. |
|
| 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. |
| 15061597 | Background | 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. |
| 20219266 | Background | 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. |
| 20878831 | Background | 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. |
| 28035649 | Derived | 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. |
| BG001 | ABCDEs of Melanoma | A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation. ABCDEs of Melanoma: Conventional melanoma educational intervention. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Education | Number | participants |
|
| Personal history of skin cancer | Number | participants |
|
| Family history of skin cancer | Number | participants |
|
| Skin reaction to the sun | Number | participants |
|
| OG001 | ABCDEs of Melanoma | A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation. ABCDEs of Melanoma: Conventional melanoma educational intervention. |
|
|
|
| Primary | 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. | Posted | Number | participants | 2 months post-intervention |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | ABCDEs of Melanoma | A conventional melanoma educational intervention using the "ABCDEs of Melanoma" pamphlet from the Skin Cancer Foundation. ABCDEs of Melanoma: Conventional melanoma educational intervention. | 0 | 50 | 0 | 50 |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Pre-I: Sun exposure is linked to melanoma |
|
| 2MF: Sun exposure is linked to melanoma |
|
| Pre-I: Knows the warning signs of melanoma |
|
| 2MF: Knows the warning signs of melanoma |
|