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

Sponsor
Turning Point (Other)
Overall Status
Completed
CT.gov ID
NCT04715516
Collaborator
Eastern Health (Other), Monash University (Other)
558
1
2
9.9
56.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: alcohol brief intervention
  • Behavioral: lifestyle health promotion
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
558 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised controlled trialRandomised controlled trial
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Feb 5, 2021
Actual Primary Completion Date :
Oct 13, 2021
Actual Study Completion Date :
Dec 2, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Knowledge of alcohol as a breast cancer risk factor [4-weeks post-randomisation]

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

Secondary Outcome Measures

  1. Drinking within current Australian Alcohol Guidelines [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) [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 [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) [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 [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 [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 [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 [4-weeks and 3-months post-randomisation]

    Change in general health (SF-12)

  9. Quality of life [4-weeks and 3-months post-randomisation]

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

Other Outcome Measures

  1. Program evaluation [Through study completion, approximately 9 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 74 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maroondah BreastScreen Ringwood East Victoria Australia 3135

Sponsors and Collaborators

  • Turning Point
  • Eastern Health
  • Monash University

Investigators

  • Principal Investigator: Dan I Lubman, Turning Point, Eastern Health; Monash University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Turning Point
ClinicalTrials.gov Identifier:
NCT04715516
Other Study ID Numbers:
  • LR19/011/50551
First Posted:
Jan 20, 2021
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Turning Point
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022