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临床试验/NCT03512457
NCT03512457已完成不适用

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

Northwestern University2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2018年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
420
试验地点
2
主要终点
Number of Participants That Performed a Skin Self-Examination at 3-months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

study arm not disclosed

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 3-months

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

次要结局

  • Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion(7-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

June Robinson

Research Professor of Dermatology

Northwestern University

研究点 (2)

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