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Skin Self-Examination Education During Mammography

Effect of Skin Self-examination Education Delivered During the Mammography Experience.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03512457
Acronym
SSE
Enrollment
420
Registered
2018-04-30
Start date
2018-05-30
Completion date
2018-10-24
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Melanoma, Skin self-examination, mammogram

Brief summary

The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.

Detailed description

The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.

Interventions

Women view an educational poster in changing room, and they receive a brochure.

Women view an educational poster in changing room, and they receive a brochure.

Sponsors

Sarah M. Friedewald, MD
CollaboratorUNKNOWN
Jennifer N. Choi, MD
CollaboratorUNKNOWN
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

study arm not disclosed

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Women 18 years of age or older * Waiting to have a mammogram

Exclusion criteria

* Male

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants That Performed a Skin Self-Examination at 3-months3-monthsThe percentage of participants that performed skin self-examination at the 3-month time interval.

Secondary

MeasureTime frameDescription
Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion7-monthsThe total number of melanomas identified by a dermatologist in women who found a concerning mole

Countries

United States

Participant flow

Participants by arm

ArmCount
Intensive Intervention
Participants receive brochure, card advising how to make an appointment with dermatology, and reminder by telephone, text message or email in one week to perform SSE. Intensive Intervention: Women view an educational poster in changing room, and they receive a brochure.
195
Minimal Intervention
Participants receive brochure, card advising how to make an appointment with dermatology. Minimal Intervention: Women view an educational poster in changing room, and they receive a brochure.
225
Total420

Baseline characteristics

CharacteristicIntensive InterventionMinimal InterventionTotal
Age, Continuous51.8 years
STANDARD_DEVIATION 9.9
53.1 years
STANDARD_DEVIATION 9.9
52.4 years
STANDARD_DEVIATION 9.9
Ethnicity (NIH/OMB)
Hispanic or Latino
22 Participants15 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
173 Participants210 Participants383 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Number of participants who had ever conducted skin self-examination prior to study participation55 Participants70 Participants125 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
8 Participants6 Participants14 Participants
Race (NIH/OMB)
Black or African American
30 Participants43 Participants73 Participants
Race (NIH/OMB)
More than one race
4 Participants4 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants9 Participants21 Participants
Race (NIH/OMB)
White
140 Participants162 Participants302 Participants
Region of Enrollment
United States
195 Participants225 Participants420 Participants
Sex: Female, Male
Female
195 Participants225 Participants420 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1950 / 225
other
Total, other adverse events
0 / 1950 / 225
serious
Total, serious adverse events
0 / 1950 / 225

Outcome results

Primary

Number of Participants That Performed a Skin Self-Examination at 3-months

The percentage of participants that performed skin self-examination at the 3-month time interval.

Time frame: 3-months

Population: Women performing skin self-examination as reported 3 months after the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intensive InterventionNumber of Participants That Performed a Skin Self-Examination at 3-months161 Participants
Educational InterventionNumber of Participants That Performed a Skin Self-Examination at 3-months185 Participants
Comparison: change from baseline to 3 months in performance of skin self-examination Parallel: response ratep-value: 0.12Chi-squared
Secondary

Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion

The total number of melanomas identified by a dermatologist in women who found a concerning mole

Time frame: 7-months

Population: Women who found a concerning mole at month 1 and month 3 and proceeded to have a skin examination by a dermatologist

ArmMeasureValue (NUMBER)
Intensive InterventionTotal Number of Melanomas Determined by Dermatologist Review of Concerning Lesion2 Melanomas
Educational InterventionTotal Number of Melanomas Determined by Dermatologist Review of Concerning Lesion5 Melanomas
Comparison: results of skin clinical examination and biopsy of clinically suspicious molesp-value: <0.05Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026