Clinical trial NCT04420273: Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access
Official title: Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Completed SSE at Specified Time Points
timeFrame: 90 days
measure: Number of Participants Who Identified Concerning Moles at Specified Time Points
timeFrame: 90 days
Secondary outcomes:
measure: Participants' Reported Skin Self-examination Anxiety
timeFrame: 90 days
measure: Participants' Confidence Performing Mole Checks
timeFrame: 90 days
measure: Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles
timeFrame: 5 months
measure: Pathologic Diagnosis of Concerning Moles
timeFrame: 5 months
measure: Biopsy Performed
timeFrame: 5 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: June K Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson JK, Reavy R, Mallett KA, Turrisi R. Remote partner assisted skin self-examination skills training of melanoma survivors and their partners. Australas J Dermatol. 2019 Feb;60(1):e80-e82. doi: 10.1111/ajd.12877. Epub 2018 Jul 10. No abstract available.
citation: Robinson JK, Wayne JD, Martini MC, Hultgren BA, Mallett KA, Turrisi R. Early Detection of New Melanomas by Patients With Melanoma and Their Partners Using a Structured Skin Self-examination Skills Training Intervention: A Randomized Clinical Trial. JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985.