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临床试验/NCT03162887
NCT03162887已完成不适用

Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness

Sidney Kimmel Cancer Center at Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2014年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Change in decisional conflict score assessed by pre- and post-intervention survey

研究概览

简要总结

This pilot clinical trial studies how well an educational module and decision counseling program works in increasing mammography screening rates in formerly homeless women with serious mental illness. An educational module and decision counseling program may be an effective tool and have the potential to help with early detection and treatment.

详细描述

PRIMARY OBJECTIVES:

I. Increase mammography screening rates in women age 40 and over with experiences of homelessness and serious mental illness (SMI).

II. Increase knowledge, decease psychological distress, and advance decision stage and intention to get a mammogram in study participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • •30 formerly homeless women with a diagnosis of a serious mental illness in the Pathways to Housing or Project HOME supportive housing programs
  • •Only women that have never received a mammogram are eligible to participate (self-report)
  • •Participants must be willing to participate in all aspects of research

排除标准

  • •Participants cannot be decisionally impaired, actively psychotic, or have unstable mental illness that prevents participation in the decisional counseling session
  • •Women who have had a mammogram will be excluded from the study

研究组 & 干预措施

Screening (education module, counseling)

Experimental

Participants receive a research team member-led breast cancer and mammogram educational module and undergo a web-based decision counseling session over 2 hours. Participants then receive a "next steps" document and may undergo an interview to discuss their decision-making process and relevant experiences during the course of the study.

干预措施: Educational Intervention (Other)

Screening (education module, counseling)

Experimental

Participants receive a research team member-led breast cancer and mammogram educational module and undergo a web-based decision counseling session over 2 hours. Participants then receive a "next steps" document and may undergo an interview to discuss their decision-making process and relevant experiences during the course of the study.

干预措施: Counseling (Other)

Screening (education module, counseling)

Experimental

Participants receive a research team member-led breast cancer and mammogram educational module and undergo a web-based decision counseling session over 2 hours. Participants then receive a "next steps" document and may undergo an interview to discuss their decision-making process and relevant experiences during the course of the study.

干预措施: Informational Intervention (Other)

结局指标

主要结局

Change in decisional conflict score assessed by pre- and post-intervention survey

时间窗: Baseline up to 1 month

Will estimate the mean pre/post change, along with a 95% confidence interval, and will test this change via a paired t-test. Will use linear regression to assess what factors (including socio-demographics and decision counseling score) are associated with the change.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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