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

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Behavioral: SSE educational intervention; Behavioral: Active control:Healthy Living

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: June K Robinson, MD, Northwestern University Feinberg School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: STU00212165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No