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临床试验/NCT04715516
NCT04715516已完成不适用

A Brief Intervention to Increase Knowledge of Alcohol as a Breast Cancer Risk Factor Among Women Attending Breast Screening Services (Health4Her): A Pilot Randomised Controlled Trial

Turning Point2 个研究点 分布在 1 个国家目标入组 558 人开始时间: 2021年2月5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
558
试验地点
2
主要终点
Knowledge of alcohol as a breast cancer risk factor

研究概览

简要总结

Alcohol is a major modifiable risk factor for breast cancer in women, yet this is not widely understood by health practitioners or policy makers, let alone the general population. The investigators aim to test the effects of a targeted alcohol and lifestyle brief intervention for women attending breast screening services, to improve knowledge of alcohol as a risk factor for breast cancer and reduce harmful alcohol use.

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)

入排标准

年龄范围
40 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • attending breast screening service for a routine mammography
  • 40-74 years
  • English as a first language or fluent
  • regular access to a telephone
  • able to provide informed consent to participate
  • any level of alcohol consumption (including non-drinkers)

排除标准

  • hearing impairment sufficient to prohibit a telephone interview
  • pregnancy
  • not able to read or comprehend English to provide informed consent or receive the brief intervention

结局指标

主要结局

Knowledge of alcohol as a breast cancer risk factor

时间窗: 4-weeks post-randomisation

Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer

次要结局

  • Health literacy - attitudes(4-weeks post-randomisation)
  • Drinking within current Australian Alcohol Guidelines(4-weeks and 3-months post-randomisation)
  • Alcohol consumption (among participants who drink more than 10 standard drinks per week)(4-weeks and 3-months post-randomisation)
  • Health literacy - access to health information(4-weeks post-randomisation)
  • General health(4-weeks and 3-months post-randomisation)
  • Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week)(4-weeks and 3-months post-randomisation)
  • Alcohol consumption(4-weeks and 3-months post-randomisation)
  • Health literacy - knowledge(4-weeks post-randomisation)
  • Quality of life(4-weeks and 3-months 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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