N/A
N=1,000
Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT04420273 ↗Enrolled (actual)
1,000
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants Who Completed SSE at Specified Time Points — 217; 242; 475; 238 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SSE educational intervention (Behavioral); Active control:Healthy Living (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed SSE at Specified Time Points |
217; 242; 475; 238; 355; 228 | <0.001 sig |
| PRIMARY Number of Participants Who Identified Concerning Moles at Specified Time Points |
39; 107; 239; 7; 0; 30 | <0.001 sig |
| SECONDARY Participants' Reported Skin Self-examination Anxiety |
6.4; 6.4; 6.6; 6.6 | < 0.1 |
| SECONDARY Participants' Confidence Performing Mole Checks |
9.3; 9.3; 11.6; 10.0 | <0.001 sig |
| SECONDARY Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles |
14; 93; 15; 9; 10; 5 | <0.001 sig |
| SECONDARY Pathologic Diagnosis of Concerning Moles |
0; 1; 13; 6; 5; 3 | 0.459 |
| SECONDARY Biopsy Performed |
56.4; 13.1 | <0.001 sig |
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.
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
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
Data sourced from ClinicalTrials.gov (NCT04420273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.