Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04715516




Registration number
NCT04715516
Ethics application status
Date submitted
11/01/2021
Date registered
20/01/2021
Date last updated
8/03/2022

Titles & IDs
Public title
Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services
Scientific 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
Secondary ID [1] 0 0
LR19/011/50551
Universal Trial Number (UTN)
Trial acronym
Health4Her
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Knowledge, Attitudes, Practice 0 0
Alcohol Consumption 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - alcohol brief intervention
Behaviour - lifestyle health promotion

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.

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.


Behaviour: 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).

Behaviour: 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.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Knowledge of alcohol as a breast cancer risk factor
Timepoint [1] 0 0
4-weeks post-randomisation
Secondary outcome [1] 0 0
Drinking within current Australian Alcohol Guidelines
Timepoint [1] 0 0
4-weeks and 3-months post-randomisation
Secondary outcome [2] 0 0
Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week)
Timepoint [2] 0 0
4-weeks and 3-months post-randomisation
Secondary outcome [3] 0 0
Alcohol consumption
Timepoint [3] 0 0
4-weeks and 3-months post-randomisation
Secondary outcome [4] 0 0
Alcohol consumption (among participants who drink more than 10 standard drinks per week)
Timepoint [4] 0 0
4-weeks and 3-months post-randomisation
Secondary outcome [5] 0 0
Health literacy - attitudes
Timepoint [5] 0 0
4-weeks post-randomisation
Secondary outcome [6] 0 0
Health literacy - knowledge
Timepoint [6] 0 0
4-weeks post-randomisation
Secondary outcome [7] 0 0
Health literacy - access to health information
Timepoint [7] 0 0
4-weeks post-randomisation
Secondary outcome [8] 0 0
General health
Timepoint [8] 0 0
4-weeks and 3-months post-randomisation
Secondary outcome [9] 0 0
Quality of life
Timepoint [9] 0 0
4-weeks and 3-months post-randomisation

Eligibility
Key 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)
Minimum age
40 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/12/2021
Sample size
Target
Accrual to date
Final
558
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Maroondah BreastScreen - Ringwood East
Recruitment postcode(s) [1] 0 0
3135 - Ringwood East

Funding & Sponsors
Primary sponsor type
Other
Name
Turning Point
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Eastern Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04715516
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dan I Lubman
Address 0 0
Turning Point, Eastern Health; Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04715516