Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services
NCT ID: NCT04715516
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
558 participants
INTERVENTIONAL
2021-02-05
2021-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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alcohol brief intervention + lifestyle health promotion
The intervention arm will receive 4 minutes of alcohol brief intervention, and 3 minutes of lifestyle health promotion (physical activity; maintaining a healthy weight), to increase knowledge of how to improve women's health and reduce breast cancer risk. Alcohol and lifestyle information will be delivered by way of an animation on an iPad. Participant responses to questions about current alcohol use will branch to personalised feedback consistent with level of alcohol consumption (i.e. drinking within or above current Australian Alcohol Guidelines).
Take-home pamphlets - a pamphlet summarising the alcohol information presented during the animation, and a pamphlet on nutrition to maintain a healthy weight, will be provided.
alcohol brief intervention
Nested within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive an alcohol brief intervention. The strong evidence-base for alcohol brief intervention, amplified by Co-Investigators' Smith and Bragge's (BehaviourWorks) approaches to applied behaviour change, has provided the framework for the development of the alcohol brief intervention used in this study. This intervention comprises personalised feedback on alcohol consumption levels, comparison to gender/age drinking norms, and information and behaviour-change content regarding alcohol consumption (i.e. negative-framed messaging around alcohol risks and harms, positive-framed messaging on the health benefits of reducing alcohol intake, alcohol harm reduction strategies).
lifestyle health promotion
Lifestyle health promotion specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.
lifestyle health promotion, not inclusive of alcohol information
The control arm will receive 3 minutes of lifestyle health promotion (physical activity; maintaining a healthy weight) to increase knowledge of how to improve women's health and reduce breast cancer risk, not inclusive of alcohol information. Lifestyle information will be delivered by way of an animation on an iPad.
Take-home pamphlet - a pamphlet on nutrition to maintain a healthy weight will be provided.
lifestyle health promotion
Lifestyle health promotion specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.
Interventions
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alcohol brief intervention
Nested within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive an alcohol brief intervention. The strong evidence-base for alcohol brief intervention, amplified by Co-Investigators' Smith and Bragge's (BehaviourWorks) approaches to applied behaviour change, has provided the framework for the development of the alcohol brief intervention used in this study. This intervention comprises personalised feedback on alcohol consumption levels, comparison to gender/age drinking norms, and information and behaviour-change content regarding alcohol consumption (i.e. negative-framed messaging around alcohol risks and harms, positive-framed messaging on the health benefits of reducing alcohol intake, alcohol harm reduction strategies).
lifestyle health promotion
Lifestyle health promotion specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* pregnancy
* not able to read or comprehend English to provide informed consent or receive the brief intervention
40 Years
74 Years
FEMALE
Yes
Sponsors
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Eastern Health
OTHER
Monash University
OTHER
Turning Point
OTHER
Responsible Party
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Principal Investigators
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Dan I Lubman
Role: PRINCIPAL_INVESTIGATOR
Turning Point, Eastern Health; Monash University
Locations
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Maroondah BreastScreen
Ringwood East, Victoria, Australia
Countries
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References
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Grigg J, Manning V, Lockie D, Giles M, Bell RJ, Stragalinos P, Bernard C, Greenwood CJ, Volpe I, Smith L, Bragge P, Lubman DI. A brief intervention for improving alcohol literacy and reducing harmful alcohol use by women attending a breast screening service: a randomised controlled trial. Med J Aust. 2023 Jun 19;218(11):511-519. doi: 10.5694/mja2.51991. Epub 2023 May 29.
Grigg J, Manning V, Lockie D, Giles M, Bell R, Stragalinos P, Bernard C, Volpe I, Greenwood CJ, Smith L, Bragge P, Lubman DI. A Brief Intervention for Improving Alcohol Literacy and Addressing Harmful Alcohol Use Among Women Attending an Australian Breast Screening Service (Health4her): Protocol for a Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2023 Mar 30;12:e44867. doi: 10.2196/44867.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Brief overview
Document Type: Statistical Analysis Plan: Full SAP
Other Identifiers
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LR19/011/50551
Identifier Type: -
Identifier Source: org_study_id
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