Skin Self-Examination Education During Mammography

Not Applicable

Completed

• Conditions: Melanoma
• Interventions: Behavioral: Intensive Intervention; Behavioral: Minimal Intervention

• Registration Number: NCT03512457
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-30
• Study Start: 2018-05-30
• Primary Completion: 2018-10-24
• Study Completion: 2018-10-24
• Results First Submitted: 2019-08-08
• Results First Submitted QC: 2020-01-23
• Results First Posted: 2020-02-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

Inclusion Criteria

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

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Exclusion Criteria

• Male

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Intervention	Intensive Intervention	Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.
Minimal Intervention	Minimal Intervention	Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Performed a Skin Self-Examination at 3-months	3-months	The percentage of participants that performed skin self-examination at the 3-month time interval.

Secondary Outcome Measures

Name	Time	Method
Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion	7-months	The total number of melanomas identified by a dermatologist in women who found a concerning mole

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine Department of Dermatology; 🇺🇸 Chicago, Illinois, United States