Melanoma
Conditions
Keywords
Melanoma, People of Color
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.
Interventions
BEHAVIORALABCDEs of Melanoma Skin Cancer
Modified melanoma educational intervention that is targeted towards people of color.
BEHAVIORALABCDEs of Melanoma
Conventional melanoma educational intervention.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Performed Regular Self-Skin Examinations | 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. |
| Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were consecutive patients seen for care at Northwestern Medicine's dermatology clinic in Chicago, IL between May and July 2015.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 12 |
Baseline characteristics
| Characteristic | ABCDEs of Melanoma Skin Cancer | ABCDEs of Melanoma | Total |
|---|---|---|---|
| Age, Customized 18-25 | 3 participants | 5 participants | 8 participants |
| Age, Customized 26-50 | 26 participants | 29 participants | 55 participants |
| Age, Customized 51-75 | 21 participants | 14 participants | 35 participants |
| Age, Customized 76+ | 0 participants | 2 participants | 2 participants |
| Education <12 years | 1 participants | 1 participants | 2 participants |
| Education College graduate | 14 participants | 17 participants | 31 participants |
| Education Graduate/professional | 21 participants | 17 participants | 38 participants |
| Education High school | 2 participants | 4 participants | 6 participants |
| Education Some college/technical school | 12 participants | 11 participants | 23 participants |
| Family history of skin cancer No | 49 participants | 44 participants | 93 participants |
| Family history of skin cancer Yes | 1 participants | 6 participants | 7 participants |
| Gender Female | 42 Participants | 43 Participants | 85 Participants |
| Gender Male | 8 Participants | 7 Participants | 15 Participants |
| Personal history of skin cancer No | 49 participants | 49 participants | 98 participants |
| Personal history of skin cancer Yes | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized African American | 39 participants | 39 participants | 78 participants |
| Race/Ethnicity, Customized American Indian and Alaskan Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 5 participants | 6 participants | 11 participants |
| Race/Ethnicity, Customized Hispanic | 6 participants | 5 participants | 11 participants |
| Skin reaction to the sun Always burn/never tan | 3 participants | 1 participants | 4 participants |
| Skin reaction to the sun Never burn/always tan | 17 participants | 19 participants | 36 participants |
| Skin reaction to the sun None of these | 9 participants | 5 participants | 14 participants |
| Skin reaction to the sun Rarely burn/usually tan | 18 participants | 24 participants | 42 participants |
| Skin reaction to the sun Usually burn/rarely tan | 3 participants | 1 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: 2 months post-intervention
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCDEs of Melanoma Skin Cancer | Number of Participants That Performed Regular Self-Skin Examinations | Pre-I: perform skin self-exam | 8 participants |
| ABCDEs of Melanoma Skin Cancer | Number of Participants That Performed Regular Self-Skin Examinations | 2MF: performed skin self-exam | 23 participants |
| ABCDEs of Melanoma | Number of Participants That Performed Regular Self-Skin Examinations | Pre-I: perform skin self-exam | 16 participants |
| ABCDEs of Melanoma | Number of Participants That Performed Regular Self-Skin Examinations | 2MF: performed skin self-exam | 25 participants |
p-value: 0.048McNemar
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.
Time frame: 2 months post-intervention
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCDEs of Melanoma Skin Cancer | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | Pre-I: Melanoma is a type of skin cancer | 27 participants |
| ABCDEs of Melanoma Skin Cancer | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | 2MF: Melanoma is a type of skin cancer | 31 participants |
| ABCDEs of Melanoma Skin Cancer | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | Pre-I: Sun exposure is linked to melanoma | 23 participants |
| ABCDEs of Melanoma Skin Cancer | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | 2MF: Sun exposure is linked to melanoma | 30 participants |
| ABCDEs of Melanoma Skin Cancer | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | Pre-I: Knows the warning signs of melanoma | 24 participants |
| ABCDEs of Melanoma Skin Cancer | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | 2MF: Knows the warning signs of melanoma | 30 participants |
| ABCDEs of Melanoma | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | Pre-I: Knows the warning signs of melanoma | 23 participants |
| ABCDEs of Melanoma | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | Pre-I: Melanoma is a type of skin cancer | 28 participants |
| ABCDEs of Melanoma | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | 2MF: Sun exposure is linked to melanoma | 36 participants |
| ABCDEs of Melanoma | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | 2MF: Melanoma is a type of skin cancer | 36 participants |
| ABCDEs of Melanoma | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | 2MF: Knows the warning signs of melanoma | 33 participants |
| ABCDEs of Melanoma | Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention | Pre-I: Sun exposure is linked to melanoma | 29 participants |
p-value: >0.5McNemar