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临床试验/NCT06019442
NCT06019442已完成不适用

An Electronic Brief Intervention to Reduce Alcohol Consumption Intentions, Improve Alcohol Literacy, and Reduce Harmful Use Among Women Attending a Breast Screening Service: a Randomised Controlled Trial

Turning Point2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Turning Point
入组人数
143
试验地点
2
主要终点
Drinking intentions

研究概览

简要总结

Alcohol is a major modifiable risk factor for female breast cancer; yet, awareness of this risk remains surprisingly low and is not systematically addressed in healthcare settings. This study aim to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.

详细描述

Alcohol is a major modifiable risk factor for female breast cancer, even in very low amounts. In Australia, alcohol consumption accounts for 6.6 per cent of cases in post-menopausal women, and 18 per cent of breast cancer deaths. Yet, awareness of this risk remains low and is not systematically addressed in healthcare settings. Embedding a brief alcohol intervention within lifestyle information offered to all women attending breast screening provides the opportunity to address harmful drinking in a discrete, non-judgmental way, to prevent alcohol-attributable breast cancer among this at-risk population.

Brief alcohol interventions are short, single-session programs typically offered in general practice settings to gather information on a person's alcohol consumption and, in a non confrontational way, provide strategies and motivate change to reduce consumption and related risk of harm. An automated brief alcohol intervention, self-completed on a device such as an iPad, is a low-cost, labour- and time-efficient approach that overcomes many of the issues of providing intervention within busy healthcare environments.

Building on the previous pilot trial of a prototype brief e-health intervention (which included alcohol-related questions asked by a researcher, and an animation viewed on an iPad that was activated by the researcher), the aim of the current study is to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The on-site researcher responsible for recruitment will not be blind to treatment assignment; the participating women self-completing baseline assessment, intervention, immediate post-intervention and 4-week follow-up assessments will be blinded to treatment assignment. The researcher who oversees follow-up assessment data collection will be blinded to treatment assignment.

入排标准

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

入选标准

  • 40+ years of age
  • Attending routine breast screening
  • With or without a breast cancer history
  • Reporting any level of alcohol consumption

排除标准

  • Not able to read or comprehend English to enable participation
  • No access to a computer, tablet or smartphone to complete follow-up assessment
  • Women who are pregnant (also an exclusion from breast screening)
  • Participation in the pilot Health4Her trial

结局指标

主要结局

Drinking intentions

时间窗: immediately post-randomisation

Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)

次要结局

  • Drinking intentions - standard drinks(4-weeks post-randomisation)
  • Knowledge of other breast cancer risk factors(4-weeks post-randomisation)
  • Drinking intentions(4-weeks post-randomisation)
  • Proportion of participants intending to reduce alcohol consumption(4-weeks post-randomisation)
  • Knowledge of alcohol as a breast cancer risk factor(4-weeks post-randomisation)
  • Alcohol literacy(4-weeks post-randomisation)
  • Alcohol consumption(4-weeks post-randomisation)

研究者

发起方
Turning Point
申办方类型
Other
责任方
Sponsor

研究点 (2)

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