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OpenTrials
Completed

NCT Number: NCT03512457

Skin Self-Examination Education During Mammography

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Male

Treatment and study plan

Minimal Intervention

Behavioral

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

Intensive Intervention

Behavioral

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

Primary outcomes

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

    Time frame: 3-months

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

Secondary outcomes

  1. Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion

    Time frame: 7-months

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Jennifer N. Choi, MD
  • Sarah M. Friedewald, MD

Registry information

Official study title

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

Acronym: SSE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 30, 2018
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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