Skin Self-Examination Education During Mammography (SSE)

Northwestern University

Status: Completed

Conditions: Melanoma

Treatments: Behavioral: Intensive Intervention; Behavioral: Minimal Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03512457

STU00207179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Male

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

Intensive Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Intensive Intervention

Minimal Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Minimal Intervention