Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services (Health4Her)

February 20, 2022 updated by: Turning Point

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
558

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Ringwood East, Victoria, Australia, 3135
        • Maroondah BreastScreen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: alcohol brief intervention + lifestyle health promotion

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 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).
Behavioral: 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.
Other: lifestyle health promotion, not inclusive of alcohol information

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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4-weeks post-randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
4-weeks and 3-months post-randomisation
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)
4-weeks and 3-months post-randomisation
Alcohol consumption
Time Frame: 4-weeks and 3-months post-randomisation
Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items)
4-weeks and 3-months post-randomisation
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)
4-weeks and 3-months post-randomisation
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)
4-weeks post-randomisation
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)
4-weeks post-randomisation
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
4-weeks post-randomisation
General health
Time Frame: 4-weeks and 3-months post-randomisation
Change in general health (SF-12)
4-weeks and 3-months post-randomisation
Quality of life
Time Frame: 4-weeks and 3-months post-randomisation
Change in quality of life (EUROHIS-QOL single item)
4-weeks and 3-months post-randomisation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Program evaluation
Time Frame: Through study completion, approximately 9 months
Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)
Through study completion, approximately 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Turning Point

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Monash University
Eastern Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dan I Lubman, Turning Point, Eastern Health; Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LR19/011/50551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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