NCT04715516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

January 11, 2021

Last Update Submit

February 20, 2022

Conditions

Health Knowledge, Attitudes, PracticeAlcohol Consumption

Keywords

Women's healthPublic HealthHealth promotion/education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Drinking within current Australian Alcohol Guidelines

    4-weeks and 3-months post-randomisation

  • Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week)

    4-weeks and 3-months post-randomisation

  • Alcohol consumption

    4-weeks and 3-months post-randomisation

  • Alcohol consumption (among participants who drink more than 10 standard drinks per week)

    4-weeks and 3-months post-randomisation

  • Health literacy - attitudes

    4-weeks post-randomisation

  • +4 more secondary outcomes

Other Outcomes (1)

  • Program evaluation

    Through study completion, approximately 9 months

Study Arms (2)

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.

Behavioral: alcohol brief interventionBehavioral: lifestyle health promotion

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.

Behavioral: lifestyle health promotion

Interventions

alcohol brief interventionBEHAVIORAL

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).

alcohol brief intervention + lifestyle health promotion
lifestyle health promotionBEHAVIORAL

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.

alcohol brief intervention + lifestyle health promotionlifestyle health promotion, not inclusive of alcohol information

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • attending breast screening service for a routine mammography
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maroondah BreastScreen

Ringwood East, Victoria, 3135, Australia

Location

Related Publications (2)

  • 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.

    PMID: 37247850DERIVED

  • 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.

    PMID: 36995739DERIVED

MeSH Terms

Conditions

BehaviorAlcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Dan I Lubman

    Turning Point, Eastern Health; Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 20, 2021

Study Start

February 5, 2021

Primary Completion

October 13, 2021

Study Completion

December 2, 2021

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

AU(1)