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

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ClinicalTrials.gov Identifier: NCT04420273
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
June Robinson, Northwestern University

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 as concerning.

Condition or disease Intervention/treatment Phase
Melanoma Behavioral: SSE educational intervention Other: Home sample collection of concerning mole with physician supervision Behavioral: Active control:Healthy Living Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter
Actual Study Start Date : July 2, 2020
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

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.

Experimental: Home sample collection of of concerning moles
The participant will be given directions about taking a picture of the concerning mole. The picture will be reviewed by the physician, who determines if the pigmented lesion is concerning and sends an adhesive patch skin sample collection kit to the participant. The participant will receive directions about obtaining the sample, and returning it to the processing laboratory. The physician will obtain the results of the genomic analysis and provide them to the participant. If the test results indicate that the concerning mole requires a biopsy, then the participant will be advised to seek an appointment within the Northwestern Medicine Healthcare System.
Other: Home sample collection of concerning mole with physician supervision
The participant will be given directions about taking a picture of the concerning mole. The picture will be reviewed by the physician, who determines if the pigmented lesion is concerning and sends an adhesive patch skin sample collection kit to the participant. The participant will receive directions about obtaining the sample, and returning it to the processing laboratory. The physician will obtain the results of the genomic analysis and provide them to the participant. If the analysis suggests that the concerning mole may be a melanoma, then the woman will be advised to have the mole biopsied and a referral will be provided.




Primary Outcome Measures :
  1. Change in SSE performance [ 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

  2. Identification of concerning mole [ 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.

  3. Effectiveness of adhesive patch-based home sample collection for genomic analysis of concerning moles to rule-out melanoma [ Time Frame: 90 Days ]
    The quantity of cells obtained for genomic analysis will be assessed. The results of the genomic analysis will be validated with the pathological findings of the biopsied concerning mole. A Student t test will be performed for the null hypothesis of no difference between the genomic analysis and the pathological finding of melanoma.


Secondary Outcome Measures :
  1. Change in skin self-examination anxiety [ Time Frame: 90 days ]
    Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score= more anxiety

  2. Change in 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.

  3. Number of physician visits for concerning moles [ Time Frame: 5 months ]
    Electronic medical record review

  4. Number of biopsies of concerning moles [ Time Frame: 5 months ]
    Electronic medical record review



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-representation as a woman
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420273


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: June K Robinson, MD Northwestern University Feinberg School of Medicine
Publications:
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Responsible Party: June Robinson, Research Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT04420273    
Other Study ID Numbers: STU00212165
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas