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Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04715516
Acronym
Health4Her
Enrollment
558
Registered
2021-01-20
Start date
2021-02-05
Completion date
2021-12-02
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Knowledge, Attitudes, Practice, Alcohol Consumption

Keywords

Women's health, Public Health, Health promotion/education

Brief summary

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.

Interventions

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 specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.

Sponsors

Eastern Health
CollaboratorOTHER
Monash University
CollaboratorOTHER
Turning Point
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Randomised controlled trial

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

* female * 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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of alcohol as a breast cancer risk factor4-weeks post-randomisationProportion of participants accurately identifying alcohol as a clear risk factor for breast cancer

Secondary

MeasureTime frameDescription
Drinking within current Australian Alcohol Guidelines4-weeks and 3-months post-randomisationProportion of participants drinking less than or equal to 10 standard drinks per week (within current Australian Alcohol Guidelines) (14-day Timeline Followback, TLFB)
Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week)4-weeks and 3-months post-randomisationAmong 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)
Alcohol consumption4-weeks and 3-months post-randomisationChange in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items)
Alcohol consumption (among participants who drink more than 10 standard drinks per week)4-weeks and 3-months post-randomisationAmong participants who drink more than 10 standard drinks per week at baseline: Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items)
Health literacy - knowledge4-weeks post-randomisationProportion 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)
Health literacy - access to health information4-weeks post-randomisationProportion of participants who have accessed health information on i) alcohol harms, ii) alcohol and breast cancer risk, and iii) alcohol harm-reduction
General health4-weeks and 3-months post-randomisationChange in general health (SF-12)
Quality of life4-weeks and 3-months post-randomisationChange in quality of life (EUROHIS-QOL single item)
Health literacy - attitudes4-weeks post-randomisationChange 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)

Other

MeasureTime frameDescription
Program evaluationThrough study completion, approximately 9 monthsMixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026