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临床试验/NCT01172561
NCT01172561已完成不适用

Reducing Cervical Cancer in Appalachia

Ohio State University Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2005年3月1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
280
试验地点
1
主要终点
Receipt of Cervical Cancer screening via Pap Test

研究概览

简要总结

To increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary.

详细描述

The overall goal of Project 1 is to increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary. The project was implemented in Appalachian Ohio, a mainly rural and underserved area with a population comprised of 1.5 million adults, aged 18 and older, and used community-based participatory research (CBPR) and community relationships already established in the area by Center investigators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

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

  • •women age 18 and older
  • •who have visited participating clinics during the last two years and
  • •who consider themselves to be a current patient of that clinic

排除标准

  • •Not a resident of the selected Ohio Appalachia county
  • •Under the age of 18

研究组 & 干预措施

Usual Care Group

Active Comparator

All women over age 18 encouraged to obtain Pap smears appropriate for their risk profile, the comparison arm included a low-literacy brochure to encourage women to receive screening. The brochure was designed to answer basic questions about Pap smears and provide instructions on how to obtain a Pap smear.

干预措施: Usual Care Group (Behavioral)

Lay Health Advisor Intervention

Experimental

The Lay Health Advisor education intervention - The intervention consisted of an intensive, reinforced, one on one, interactive ed. program (an initial meeting, then 2 calls and a series of 4 postcards mailed at regular intervals and a 2nd visit. Woman were enrolled for about 12 to 14 months.

干预措施: Lay Health Advisor Education Intervention (Behavioral)

结局指标

主要结局

Receipt of Cervical Cancer screening via Pap Test

时间窗: past 12-14 months (yes/no).

the primary outcome of interest for Project 1 intervention will be a dichotomous variable, Pap smear in the past 12-14 months (yes/no). Initially, We will assess the univariate difference between treatment groups (lay health advisor vs. brochure and physician letter) in the proportion of women who received a Pap smear during the past 12 months using design-based logistic regression.

次要结局

未报告次要终点

研究者

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

Electra Paskett

Professor

Ohio State University Comprehensive Cancer Center

研究点 (1)

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