Skin Self-Examination Education During Mammography

Melanoma Clinical Trial

— SSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512457
• Other study ID #: STU00207179
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: October 24, 2018

Study information

• Verified date: March 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women 18 years of age or older

• Waiting to have a mammogram

Exclusion Criteria:

• Male

Related Conditions & MeSH terms

• Melanoma

Intervention

Behavioral:
• Minimal Intervention
Women view an educational poster in changing room, and they receive a brochure.
• Intensive Intervention
Women view an educational poster in changing room, and they receive a brochure.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine Department of Dermatology	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Jennifer N. Choi, MD, Sarah M. Friedewald, MD

Country where clinical trial is conducted

United States, 

References & Publications (2)

Robinson JK, Perez M, Abou-El-Seoud D, Kim K, Brown Z, Liko-Hazizi E, Friedewald SM, Kwasny M, Spring B. Targeted Melanoma Screening: Risk Self-Assessment and Skin Self-Examination Education Delivered During Mammography of Women. JNCI Cancer Spectr. 2019 — View Citation

Rzepecki AK, Jain N, Ali Y, Chavez L, Choi J, Schlosser B, Liko-Hazizi E, Friedewald SM, Robinson JK. Promoting early detection of melanoma during the mammography experience. Int J Womens Dermatol. 2017 Jul 5;3(4):195-200. doi: 10.1016/j.ijwd.2017.06.002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3-months
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	7-months