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临床试验/NCT00765869
NCT00765869Unknown不适用

A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy

University of Sydney2 个研究点 分布在 1 个国家目标入组 555 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
555
试验地点
2
主要终点
Informed choice

研究概览

简要总结

The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.

详细描述

Several countries have recently implemented national bowel cancer screening programs. To ensure equal access to screening, consumer information is needed to suit adults ranging in literacy level. Decision aids (DAs) are tools which have been developed to assist patients and consumers make informed health decisions and encourage active participation in health care decisions. Their use in a wide range of clinical settings has increased dramatically. However, most DAs are highly dependent upon high levels of literacy and numeracy, and few have been developed for low literacy populations.

This primary aims of this study are to assess the impact of the decision aid on (1) the proportion of adults who make an informed choice about bowel cancer screening (using faecal occult blood test) and, (2) the level of involvement in screening decisions among adults with lower levels of education and literacy.

There are three secondary aims of the study. First, to measure the effect of the decision support tool on decisional conflict, decision satisfaction, anxiety, and bowel cancer worry. Second, to identify participant's screening interest, intentions and behavior. Thirdly, we will explore participant's reactions towards the information materials they receive and whether the doctor influenced their screening decision.

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 (Participant)

入排标准

年龄范围
55 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 55-64 years
  • Lower levels of education
  • English as a main language spoken at home
  • Average risk of bowel cancer

排除标准

  • Higher levels of education
  • Invitation to take part in bowel cancer screening in last two years
  • Personal or strong family history of bowel cancer
  • Had a bowel cancer screening test in the last two years

结局指标

主要结局

Informed choice

时间窗: 2 weeks post intervention

Involvement in screening decision

时间窗: 2 weeks post intervention

次要结局

  • Anxiety(2 weeks post intervention)
  • Bowel cancer worry(2 weeks post intervention)
  • Decisional conflict(2 weeks post intervention)
  • Decision satisfaction(2 weeks post intervention)
  • Bowel cancer screening interest(2 weeks post intervention)
  • Bowel cancer screening intentions(2 weeks post intervention)
  • Screening behaviour(2 weeks post intervention)
  • Self reported bowel cancer symptoms(2 weeks post intervention)
  • Evaluation of intervention materials(2 weeks post intervention)
  • Influence of doctor on screening decision(2 weeks post intervention)

研究者

申办方类型
Other

研究点 (2)

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