Skin Self-Examination Education During Mammography (SSE)
Primary Purpose
Melanoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minimal Intervention
Intensive Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Melanoma focused on measuring Melanoma, Skin self-examination, mammogram
Eligibility Criteria
Inclusion Criteria:
- Women 18 years of age or older
- Waiting to have a mammogram
Exclusion Criteria:
- Male
Sites / Locations
- Northwestern University Feinberg School of Medicine Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive Intervention
Minimal Intervention
Arm Description
Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.
Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03512457
First Posted
April 11, 2018
Last Updated
March 23, 2021
Sponsor
Northwestern University
Collaborators
Sarah M. Friedewald, MD, Jennifer N. Choi, MD
1. Study Identification
Unique Protocol Identification Number
NCT03512457
Brief Title
Skin Self-Examination Education During Mammography
Acronym
SSE
Official Title
Effect of Skin Self-examination Education Delivered During the Mammography Experience.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Sarah M. Friedewald, MD, Jennifer N. Choi, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Skin self-examination, mammogram
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
study arm not disclosed
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive Intervention
Arm Type
Experimental
Arm Description
Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.
Arm Title
Minimal Intervention
Arm Type
Active Comparator
Arm Description
Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.
Intervention Type
Behavioral
Intervention Name(s)
Minimal Intervention
Intervention Description
Women view an educational poster in changing room, and they receive a brochure.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Intervention
Intervention Description
Women view an educational poster in changing room, and they receive a brochure.
Primary Outcome Measure Information:
Title
Number of Participants That Performed a Skin Self-Examination at 3-months
Description
The percentage of participants that performed skin self-examination at the 3-month time interval.
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion
Description
The total number of melanomas identified by a dermatologist in women who found a concerning mole
Time Frame
7-months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women waiting to have a mammogram
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women 18 years of age or older
Waiting to have a mammogram
Exclusion Criteria:
Male
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June K. Robinson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29234713
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. eCollection 2017 Dec.
Results Reference
result
PubMed Identifier
32328556
Citation
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 Jun 28;3(3):pkz047. doi: 10.1093/jncics/pkz047. eCollection 2019 Sep.
Results Reference
result
PubMed Identifier
32090289
Citation
Robinson JK, Brown Z, Spring B. Melanoma Skin Self-Examination Education During Mammography: Health Burden of Women Impairs Implementation. J Cancer Educ. 2021 Aug;36(4):858-864. doi: 10.1007/s13187-020-01714-4.
Results Reference
derived
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Skin Self-Examination Education During Mammography
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