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Health Knowledge, Attitudes, PracticeHealth4HerNCT04715516

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

A study testing alcohol brief intervention and lifestyle health promotion in people with Health Knowledge, Attitudes, Practice and Alcohol Consumption, run by Turning Point at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 74 years, women onlyHealthy volunteers can take part
What is being tested?
alcohol brief intervention and lifestyle health promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
558 participants
Where
1 siteAustralia
Study dates
5 Feb 2021to 2 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 74 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Maroondah BreastScreen

    Ringwood East, Victoria, 3135

Other trials in Australia

About this study

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

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.

Being tested
alcohol brief intervention, lifestyle health promotion
Keywords
Women's health, Public Health, Health promotion/education
Medical subject headings
Behavior, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alcohol brief interventionBehavioural

    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 promotionBehavioural

    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.

Study groups in NCT04715516
Study groupRoleWhat they receive
alcohol brief intervention + lifestyle health promotionExperimentalThe 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.
Receives: Behavioral: alcohol brief intervention; Behavioral: lifestyle health promotion
lifestyle health promotion, not inclusive of alcohol informationOtherThe 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.
Receives: Behavioral: lifestyle health promotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge of alcohol as a breast cancer risk factor

    Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer

    Measured: 4-weeks post-randomisation

Secondary outcomes (9)

  1. 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)

    Measured: 4-weeks and 3-months post-randomisation

  2. 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)

    Measured: 4-weeks and 3-months post-randomisation

  3. Alcohol consumption

    Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items)

    Measured: 4-weeks and 3-months post-randomisation

  4. 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)

    Measured: 4-weeks and 3-months post-randomisation

  5. 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)

    Measured: 4-weeks post-randomisation

  6. 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)

    Measured: 4-weeks post-randomisation

  7. 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

    Measured: 4-weeks post-randomisation

  8. General health

    Change in general health (SF-12)

    Measured: 4-weeks and 3-months post-randomisation

  9. Quality of life

    Change in quality of life (EUROHIS-QOL single item)

    Measured: 4-weeks and 3-months post-randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start5 Feb 2021
  3. Primary completion13 Oct 2021
  4. Study completion2 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04715516
Sponsor's protocol ID
LR19/011/50551
Acronym
Health4Her
Status last verified
Feb 2022
First submitted
11 Jan 2021
Last updated
8 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 37247850

  • 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.

    PubMed 36995739

Questions about this trial

What is this clinical trial studying?

A study testing alcohol brief intervention and lifestyle health promotion in people with Health Knowledge, Attitudes, Practice and Alcohol Consumption, run by Turning Point at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge of alcohol as a breast cancer risk factor (time frame: 4-weeks post-randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04715516, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.

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