Moderating the Negative Impact of Abnormal Screening Mammograms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
研究概览
简要总结
This project evaluates the impact of CHESS-Mammo by assessing participants' health information competence, psychological distress, and satisfaction with their doctor as measured by previously validated survey questionnaires.
详细描述
The study consists of two parts. Part 1 (focus groups) interviewed 11 women in total (6 diagnosed with breast cancer and 5 diagnosed with benign breast disease) reinforced the need for online information during the breast diagnostic process. The focus group reviewed online CHESS-Mammo module and suggested minor changes to content. Part 2 (Evaluation) will enroll 130 women in study and compare one group (65 participants) who receives access to CHESS-Mammo to another group of women (65 participants) who receive an email message containing screening mammography information. Both groups in Part 2 will be evaluated for health information competence, psychological distress, and patient satisfaction with physician through questionnaires. An evaluation of the group that accesses the CHESS-Mammo website will be done. The reason for conducting part 2 of this study is to allow greater insight into the clinical application of a novel Interactive Cancer Communication Systems (CHESS-Mammo) early in the diagnostic workup of breast cancer. By doing this project, we may achieve an important new way of implementing CHESS-Mammo in the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, subjects must:
- •Be females at least 18 years of age,
- •Have had their screening mammogram performed at the UW Breast Center,
- •Be able to read and write English at the 6th grade level (as shown by their, ability to understand the informed consent),
- •Have access to a computer with internet capability.
排除标准
- •Exclusion Criteria:
- •Illiterate
研究组 & 干预措施
No Intervention: Usual Care
A group receiving usual care plus 5 reliable websites
Intervention
A group using the Comprehensive Health Enhancement Support System (CHESS.)
干预措施: Comprehensive Health Enhancement Support System (CHESS.) (Behavioral)
结局指标
主要结局
This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
时间窗: 3 weeks
This is a randomized controlled trial in which half of the participants will receive access to CHESS-Mammo during their diagnostic workup of an abnormal screening mammogram, and the other half will receive basic information in addition to usual care. This design will allow us to compare the health information competence, psychological distress, and patient satisfaction with their doctor among the two groups.
次要结局
未报告次要终点