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

NCT ID: NCT04420273

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2021-03-01

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.

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.

Conditions

Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

SSE educational intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Active control:Healthy Living

Intervention Type: 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.

Interventions

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 Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

June Robinson

Research Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

June K Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30773613 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27367303 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00212165

Identifier Type: -

Identifier Source: org_study_id