Clinical trial NCT04715516: Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Alcohol Consumption
Keywords: Women's health
Public Health
Health promotion/education
Lead sponsor: Turning Point
Sponsor class: OTHER
Collaborators: name: Eastern Health
name: Monash University
First posted: 2021-01-20
Enrollment: 558
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of alcohol as a breast cancer risk factor
timeFrame: 4-weeks post-randomisation
Secondary outcomes:
measure: Drinking within current Australian Alcohol Guidelines
timeFrame: 4-weeks and 3-months post-randomisation
measure: Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week)
timeFrame: 4-weeks and 3-months post-randomisation
measure: Alcohol consumption
timeFrame: 4-weeks and 3-months post-randomisation
measure: Alcohol consumption (among participants who drink more than 10 standard drinks per week)
timeFrame: 4-weeks and 3-months post-randomisation
measure: Health literacy - attitudes
timeFrame: 4-weeks post-randomisation
measure: Health literacy - knowledge
timeFrame: 4-weeks post-randomisation
measure: Health literacy - access to health information
timeFrame: 4-weeks post-randomisation
measure: General health
timeFrame: 4-weeks and 3-months post-randomisation
measure: Quality of life
timeFrame: 4-weeks and 3-months post-randomisation
Other outcomes:
measure: Program evaluation
timeFrame: Through study completion, approximately 9 months
Locations:
city: Ringwood East
country: Australia
facility: Maroondah BreastScreen
state: Victoria
Study officials:
affiliation: Turning Point, Eastern Health; Monash University
name: Dan I Lubman
role: PRINCIPAL_INVESTIGATOR
References: