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| Name | Class |
|---|---|
| Eastern Health | OTHER |
| Monash University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alcohol brief intervention + lifestyle health promotion | Experimental | 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. |
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| lifestyle health promotion, not inclusive of alcohol information | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alcohol brief intervention | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of alcohol as a breast cancer risk factor | Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer | 4-weeks post-randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Drinking within current Australian Alcohol Guidelines | Proportion of participants drinking less than or equal to 10 standard drinks per week (within current Australian Alcohol Guidelines) (14-day Timeline Followback, TLFB) | 4-weeks and 3-months post-randomisation |
| Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week) |
| Measure | Description | Time Frame |
|---|---|---|
| Program evaluation | Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework) | Through study completion, approximately 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan I Lubman | Turning Point, Eastern Health; Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maroondah BreastScreen | Ringwood East | Victoria | 3135 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37247850 | Derived | 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. | |
| 36995739 |
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We do not have Ethics approval to seek patient permission to share data outside this study, other than for related projects conducted by the research team.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Brief overview | Aug 8, 2021 | Feb 2, 2022 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Full SAP | Feb 18, 2022 | Feb 20, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Randomised controlled trial
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| lifestyle health promotion | Behavioral | 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. |
|
Among participants who drink more than 10 standard drinks per week at baseline: Proportion of participants drinking less than or equal to 10 standard drinks per week. (14-day TLFB) |
| 4-weeks and 3-months post-randomisation |
| Alcohol consumption | Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items) | 4-weeks and 3-months post-randomisation |
| Alcohol consumption (among participants who drink more than 10 standard drinks per week) | Among participants who drink more than 10 standard drinks per week at baseline: Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items) | 4-weeks and 3-months post-randomisation |
| Health literacy - attitudes | Change in participants' attitudes regarding alcohol and breast cancer risk (5-point scale, strongly agree to strongly disagree; items adapted from previous literature, e.g. Fisher et al. 2017) | 4-weeks post-randomisation |
| Health literacy - knowledge | Proportion of participants accurately identifying i) the amount of alcohol in an Australian standard drink; ii) the number of standard drinks in an average restaurant serve of red wine; iii) the maximum number of standard drinks per week recommended by current Australian Alcohol Guidelines (multiple choice and open-ended questions, adapted from previous literature, e.g. Bowden et al. 2014) | 4-weeks post-randomisation |
| Health literacy - access to health information | Proportion of participants who have accessed health information on i) alcohol harms, ii) alcohol and breast cancer risk, and iii) alcohol harm-reduction | 4-weeks post-randomisation |
| General health | Change in general health (SF-12) | 4-weeks and 3-months post-randomisation |
| Quality of life | Change in quality of life (EUROHIS-QOL single item) | 4-weeks and 3-months post-randomisation |
| Derived |
| 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. |