Melanoma
Conditions
Keywords
Melanoma, Skin self-examination, mammogram
Brief summary
The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.
Detailed description
The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.
Interventions
Women view an educational poster in changing room, and they receive a brochure.
Women view an educational poster in changing room, and they receive a brochure.
Sponsors
Study design
Masking description
study arm not disclosed
Eligibility
Inclusion criteria
* Women 18 years of age or older * Waiting to have a mammogram
Exclusion criteria
* Male
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Performed a Skin Self-Examination at 3-months | 3-months | The percentage of participants that performed skin self-examination at the 3-month time interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion | 7-months | The total number of melanomas identified by a dermatologist in women who found a concerning mole |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intensive Intervention Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE.
Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure. | 195 |
| Minimal Intervention Participants receive brochure, card advising how to make an appointment with dermatology.
Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure. | 225 |
| Total | 420 |
Baseline characteristics
| Characteristic | Intensive Intervention | Minimal Intervention | Total |
|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 9.9 | 53.1 years STANDARD_DEVIATION 9.9 | 52.4 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 15 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 173 Participants | 210 Participants | 383 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of participants who had ever conducted skin self-examination prior to study participation | 55 Participants | 70 Participants | 125 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 43 Participants | 73 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 9 Participants | 21 Participants |
| Race (NIH/OMB) White | 140 Participants | 162 Participants | 302 Participants |
| Region of Enrollment United States | 195 Participants | 225 Participants | 420 Participants |
| Sex: Female, Male Female | 195 Participants | 225 Participants | 420 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 195 | 0 / 225 |
| other Total, other adverse events | 0 / 195 | 0 / 225 |
| serious Total, serious adverse events | 0 / 195 | 0 / 225 |
Outcome results
Number of Participants That Performed a Skin Self-Examination at 3-months
The percentage of participants that performed skin self-examination at the 3-month time interval.
Time frame: 3-months
Population: Women performing skin self-examination as reported 3 months after the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intensive Intervention | Number of Participants That Performed a Skin Self-Examination at 3-months | 161 Participants |
| Educational Intervention | Number of Participants That Performed a Skin Self-Examination at 3-months | 185 Participants |
Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion
The total number of melanomas identified by a dermatologist in women who found a concerning mole
Time frame: 7-months
Population: Women who found a concerning mole at month 1 and month 3 and proceeded to have a skin examination by a dermatologist
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Intervention | Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion | 2 Melanomas |
| Educational Intervention | Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion | 5 Melanomas |