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

NCT04420273 | Completed Results DMC

• 1 other identifier: STU00212165
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Participants' Reported Skin Self-examination Anxiety

  90 days

• Participants' Confidence Performing Mole Checks

  90 days

• Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles

  5 months

• Pathologic Diagnosis of Concerning Moles

  5 months

• Biopsy Performed

  5 months

Study Arms (2)

SSE educational intervention

EXPERIMENTAL

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

Active control: Healthy Living

ACTIVE COMPARATOR

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

Interventions

SSE educational intervention BEHAVIORAL

Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.

SSE educational intervention

Active control:Healthy Living BEHAVIORAL

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.

Active control: Healthy Living

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-representation as a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male or female over the age of 18 years
• Able to read English
• Vision enough to read a newspaper

You may not qualify if:

• Male
• Female under the age of 18
• Unable to read English

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• 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.

  PMID: 30773613 BACKGROUND

• 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.

  PMID: 27367303 BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. June Robinson
• Organization: Northwestern University Feinberg School of Medicine

june-robinson@northwestern.edu

3129433703

Study Officials

• June K Robinson, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Dermatology

Model Details: 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

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: July 2, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)