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OpenTrials
Completed

NCT Number: NCT04715516

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

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.

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Key information

Conditions

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

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maroondah BreastScreen

Ringwood East, Victoria, 3135, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol brief intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Knowledge of alcohol as a breast cancer risk factor

    Time frame: 4-weeks post-randomisation

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

Secondary outcomes

  1. Drinking within current Australian Alcohol Guidelines

    Time frame: 4-weeks and 3-months post-randomisation

    Proportion of participants drinking less than or equal to 10 standard drinks per week (within current Australian Alcohol Guidelines) (14-day Timeline Followback, TLFB)

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

    Time frame: 4-weeks and 3-months post-randomisation

    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)

  3. Alcohol consumption

    Time frame: 4-weeks and 3-months post-randomisation

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

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

    Time frame: 4-weeks and 3-months post-randomisation

    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)

  5. Health literacy - attitudes

    Time frame: 4-weeks post-randomisation

    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)

  6. Health literacy - knowledge

    Time frame: 4-weeks post-randomisation

    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)

  7. Health literacy - access to health information

    Time frame: 4-weeks post-randomisation

    Proportion of participants who have accessed health information on i) alcohol harms, ii) alcohol and breast cancer risk, and iii) alcohol harm-reduction

  8. General health

    Time frame: 4-weeks and 3-months post-randomisation

    Change in general health (SF-12)

  9. Quality of life

    Time frame: 4-weeks and 3-months post-randomisation

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

Other outcomes

  1. Program evaluation

    Time frame: Through study completion, approximately 9 months

    Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)

Sponsors and collaborators

Lead sponsor

Turning Point

Other

Collaborators

  • Eastern Health
  • Monash University

Registry information

Official study 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

Acronym: Health4Her

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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