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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

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE July 2, 2020
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • 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
  • 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.
  • Number of physician visits for concerning moles [ Time Frame: 5 months ]
    Electronic medical record review
  • Number of biopsies of concerning moles [ Time Frame: 5 months ]
    Electronic medical record review
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access
Official Title  ICMJE Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Melanoma
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: SSE educational intervention
  • 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.
    Intervention: Behavioral: Active control: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.
    Intervention: Other: Home sample collection of concerning mole with physician supervision
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2020)
1000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2021
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Self-representation as a woman
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04420273
Other Study ID Numbers  ICMJE STU00212165
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party June Robinson, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: June K Robinson, MD Northwestern University Feinberg School of Medicine
PRS Account Northwestern University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP