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临床试验/NCT04509063
NCT04509063已完成不适用

Investigating Public Enthusiasm for Mammography Screening in Denmark

University of Aarhus2 个研究点 分布在 1 个国家目标入组 768 人开始时间: 2020年11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
768
试验地点
2
主要终点
Irrational preference

研究概览

简要总结

Based on an American study by Scherer et al., it is hypothesized that some women will make irrational choices regarding their participation in mammography screening. Therefore, the aim is to estimate the prevalence of Danish women having an irrational preference for mammography screening even when it confers no benefits, but only harms.

详细描述

The prevalence of women making an irrational decision will be compared to the participation rate in the Danish screening program. The study population will consist of a random sample of women aged 44-49. Similar to the American study, two types of information will be compared (detailed vs. non-detailed information about the harms of screening). Participants will be randomised to one of two information groups. Based on the American study, it is assumed that the willingness to participate in the hypothetical screening program will be 40 percent. To achieve the desired precision in this study, a standard error of 2.5 percent is required corresponding to a confidence interval spanning approximately 35-45 percent. This will require 384 women in each group, corresponding to a total study population of 768. The survey will be sent electronically (using "e-Boks") with a link to access the online survey trial. The survey will consist of screening and cancer related questions as well as questions on age, education, and health literacy. Five questions on appraisal of health information from the Health Literacy Questionnaire will also be included. After the data collection, data will be linked to data on income, residence, civil status, education, breast cancer diagnosis, and information on whether a participant is immigrant, descendent or of Danish origin.

The original plan for the main analysis was to compare the two groups of women randomized to different information groups (detailed vs. non-detailed information about the harms of screening). However, due to lower participation rate and therefore smaller sample size than expected, information group was disregarded in the main analysis. The two groups will still be compared in a secondary analysis. This decision was made before getting access to data from the questionnaire.

研究设计

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

盲法说明

Self administered questionnaire

入排标准

年龄范围
44 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Residence: Central Denmark Region

排除标准

  • 未提供

研究组 & 干预措施

Non-detailed information about screening harms

Other

干预措施: Information about hypothetical mammography screening without benefits (Behavioral)

Detailed information about screening harms

Other

干预措施: Information about hypothetical mammography screening without benefits (Behavioral)

结局指标

主要结局

Irrational preference

时间窗: The outcome is assessed when women answer the questionnaire which is sent out at the same time to all women. The invited women will have 2 months to answer the questionnaire (it should only take around 15 minutes to answer). Planned from November 2020.

Willingness to participate in mammography screening with no benefits on morbidity or mortality, only harms. Investigated by sending out questionnaire once to all women.

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 (2)

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