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

Primary Purpose

Health Knowledge, Attitudes, Practice, Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
alcohol brief intervention
lifestyle health promotion
Sponsored by
Turning Point
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Health Knowledge, Attitudes, Practice focused on measuring Women's health, Public Health, Health promotion/education

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maroondah BreastScreen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

alcohol brief intervention + lifestyle health promotion

lifestyle health promotion, not inclusive of alcohol information

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
Alcohol consumption
Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items)
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)
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)
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)
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
General health
Change in general health (SF-12)
Quality of life
Change in quality of life (EUROHIS-QOL single item)

Full Information

First Posted
January 11, 2021
Last Updated
February 20, 2022
Sponsor
Turning Point
Collaborators
Eastern Health, Monash University
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1. Study Identification

Unique Protocol Identification Number
NCT04715516
Brief Title
Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services
Acronym
Health4Her
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
October 13, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turning Point
Collaborators
Eastern Health, Monash University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Knowledge, Attitudes, Practice, Alcohol Consumption
Keywords
Women's health, Public Health, Health promotion/education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alcohol brief intervention + lifestyle health promotion
Arm Type
Experimental
Arm Description
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.
Arm Title
lifestyle health promotion, not inclusive of alcohol information
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
alcohol brief intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
lifestyle health promotion
Intervention Description
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 Outcome Measure Information:
Title
Knowledge of alcohol as a breast cancer risk factor
Description
Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer
Time Frame
4-weeks post-randomisation
Secondary Outcome Measure Information:
Title
Drinking within current Australian Alcohol Guidelines
Description
Proportion of participants drinking less than or equal to 10 standard drinks per week (within current Australian Alcohol Guidelines) (14-day Timeline Followback, TLFB)
Time Frame
4-weeks and 3-months post-randomisation
Title
Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week)
Description
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)
Time Frame
4-weeks and 3-months post-randomisation
Title
Alcohol consumption
Description
Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items)
Time Frame
4-weeks and 3-months post-randomisation
Title
Alcohol consumption (among participants who drink more than 10 standard drinks per week)
Description
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)
Time Frame
4-weeks and 3-months post-randomisation
Title
Health literacy - attitudes
Description
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)
Time Frame
4-weeks post-randomisation
Title
Health literacy - knowledge
Description
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)
Time Frame
4-weeks post-randomisation
Title
Health literacy - access to health information
Description
Proportion of participants who have accessed health information on i) alcohol harms, ii) alcohol and breast cancer risk, and iii) alcohol harm-reduction
Time Frame
4-weeks post-randomisation
Title
General health
Description
Change in general health (SF-12)
Time Frame
4-weeks and 3-months post-randomisation
Title
Quality of life
Description
Change in quality of life (EUROHIS-QOL single item)
Time Frame
4-weeks and 3-months post-randomisation
Other Pre-specified Outcome Measures:
Title
Program evaluation
Description
Mixed-methods program evaluation (Glasgow et al.'s RE-AIM framework)
Time Frame
Through study completion, approximately 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan I Lubman
Organizational Affiliation
Turning Point, Eastern Health; Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maroondah BreastScreen
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

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

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