- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04420273
Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access (TMD)
November 19, 2021 updated by: June Robinson, Northwestern University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
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.
|
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.
|
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
Time Frame: 90 days
|
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
Time Frame: 90 days
|
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
Time Frame: 90 days
|
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
Time Frame: 90 days
|
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
Time Frame: 5 months
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Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months
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5 months
|
Pathologic Diagnosis of Concerning Moles
Time Frame: 5 months
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Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning
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5 months
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Biopsy Performed
Time Frame: 5 months
|
EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed
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5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: June K Robinson, MD, Northwestern University Feinberg School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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