Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter

Conditions
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Melanoma

Intervention / Treatment
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* Behavioral: SSE educational intervention
* Behavioral: Active control:Healthy Living


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Clinical Trial Arm 1: SSE educational intervention with optional physician supervised non-invasive adhesive patch-based home sample collection of a concerning mole for genomic analysis Arm 2: Active control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSE educational intervention<br>Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. | Behavioral: SSE educational intervention<br>* Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.<br>|
| Active Comparator: Active control: Healthy Living<br>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. | Behavioral: Active control:Healthy Living<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed SSE at Specified Time Points | Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey | 90 days | 
| Number of Participants Who Identified Concerning Moles at Specified Time Points | Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' Reported Skin Self-examination Anxiety | Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome | 90 days | 
| Participants' Confidence Performing Mole Checks | Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome). | 90 days | 
| Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles | Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months | 5 months | 
| Pathologic Diagnosis of Concerning Moles | Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning | 5 months | 
| Biopsy Performed | EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed | 5 months |