Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services (Health4Her)

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption; Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Behavioral: alcohol brief intervention; Behavioral: lifestyle health promotion

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Ringwood East, Victoria, Australia, 3135
      • Maroondah BreastScreen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).; Behavioral: 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.
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program evaluation	Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)	Through study completion, approximately 9 months

Collaborators and Investigators

• Sponsor: Turning Point
• Collaborators: Monash University; Eastern Health
• Investigators: Principal Investigator: Dan I Lubman, Turning Point, Eastern Health; Monash University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): December 2, 2021

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Public Health; Women's health; Health promotion/education
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: LR19/011/50551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No