The purpose of this study is to reduce melanoma mortality by improving early detection of melanoma with skin self-examination (SSE) among people who self-identify as being at risk and seek care for a concerning mole. Because women are more likely than men to perform SSE, women who are engaged in health promotion by having a recent screening mammogram are the focus of this research. Self-management of melanoma detection with SSE depends on ready access to dermatologists when a concerning mole is detected. In March 2020, the Illinois stay at home order (COVID-19) prohibited non-essential health care, including screening mammography and dermatology office-based care, and both are expected to remain limited until fall 2020. This submission explores a) the effectiveness of targeted melanoma detection (TMD) among women, who identify their risk of having a melanoma, learn to perform SSE, and perform SSE, and b) the effectiveness of adhesive patch-based home sample collection for genomic analysis to rule out melanoma in moles identified by women (who received the intervention) as concerning will be explored.
The proposed work will assess the effectiveness of targeted melanoma detection (TMD) with SSE
education delivered remotely to women who had a screening mammogram. The effect of TMD with
SSE education will be assessed with a randomized control trial among women served by
Northwestern Medicine in rural, suburban and metropolitan communities. Women who identify
concerning moles will choose among three options: a) watch the mole to see if the border,
color or diameter of the mole changes b) send a picture of the mole to the PI for
consideration of mole self-sampling, or c) make an appointment with my healthcare provider to
check the mole. As required a physician will supervise women, who will perform non-invasive
mole self-sampling with non-invasive adhesive patches for genomic analysis of the concerning
pigmented lesion (mole). If the genomic analysis suggests that the concerning mole may be a
melanoma, then the recommendation will be to have the mole biopsied.The effectiveness of
acquired samples suggestive of melanoma will be examined by the obtaining the pathology
reports of biopsied moles. Health care providers' (HCPs) clinical/pathologic assessment of
concerning moles will be identified in the Northwestern Medicine electronic health record
(EHR) system.
Behavioral: SSE educational intervention
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
Behavioral: Active control:Healthy Living
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Inclusion Criteria:
- Adult women (aged 18 and older) with no upper age limit, who had a screening mammogram
from January 1, 2019 to February 28, 2020.
- Able to read English
- Vision enough to read a newspaper
- Self-perception of their potential melanoma risk
- Willing to perform SSE either alone or with a skin check partner
- Willing to complete monthly surveys for 3 months and receive monthly text messages to
personal mobile phone
- Have home Internet access and phone with ability to take a picture of a mole
- Have access to Federal Express or US Postal Service Express Mail to send mole
self-sampling kits
- Willing to allow the research team access to their electronic health record to
abstract physician assessment of concerning moles, biopsy results and treatment
- Willing to provide up-to-date email address, mailing address and telephone number
Inclusion criteria of skin check partner, who may be a man or a woman, to have mole
self-sampled
- Male or female over the age of 18 years
- Able to read English
- Vision enough to read a newspaper
Exclusion Criteria:
- Male
- Female under the age of 18
- Unable to read English
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, United States
June K Robinson, MD, Principal Investigator
Northwestern University Feinberg School of Medicine