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

NCT04420273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2021-11-23

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • June K Robinson, MD · Northwestern University Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420273 on ClinicalTrials.gov