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

Health Knowledge, Attitudes, Practice Clinical Trial

— Health4Her  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715516
• Other study ID #: LR19/011/50551
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: February 2022
• Source: Turning Point
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: December 2, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Health Knowledge, Attitudes, Practice

Intervention

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).
• 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.

Locations

Country	Name	City	State
Australia	Maroondah BreastScreen	Ringwood East	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Turning Point	Eastern Health, Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program evaluation	Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)	Through study completion, approximately 9 months
Primary	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	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
Secondary	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
Secondary	Alcohol consumption	Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items)	4-weeks and 3-months post-randomisation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	General health	Change in general health (SF-12)	4-weeks and 3-months post-randomisation
Secondary	Quality of life	Change in quality of life (EUROHIS-QOL single item)	4-weeks and 3-months post-randomisation