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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06019442




Registration number
NCT06019442
Ethics application status
Date submitted
13/08/2023
Date registered
31/08/2023

Titles & IDs
Public title
An Electronic Brief Alcohol Intervention for Women Attending a Breast Screening Service (Health4Her)
Scientific title
An Electronic Brief Intervention to Reduce Alcohol Consumption Intentions, Improve Alcohol Literacy, and Reduce Harmful Use Among Women Attending a Breast Screening Service: a Randomised Controlled Trial
Secondary ID [1] 0 0
LR22-071-91112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Knowledge, Attitudes, Practice 0 0
Alcohol Drinking 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
BEHAVIORAL - Brief alcohol intervention (Health4Her-Automated)
BEHAVIORAL - Lifestyle health promotion

Experimental: Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion - The intervention arm will receive:

* brief alcohol intervention
* lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.

Participants will receive an iPad and earphones to self-complete the intervention. Alcohol and lifestyle information will be delivered by way of an animation on an iPad, and self-completed activities to reinforce intervention content.

Other: Lifestyle health promotion - The control arm will receive:

* lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.

Participants will receive an iPad and earphones to self-complete the control intervention. Lifestyle information will be delivered by way of an animation on an iPad, and a self-completed activity to reinforce intervention content.


BEHAVIORAL: Brief alcohol intervention (Health4Her-Automated)
Embedded within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive a brief alcohol intervention. The brief alcohol intervention will comprise information and behaviour-change content regarding alcohol consumption, including: messaging around alcohol risks/harms (with a focus on alcohol use and breast cancer risk), positive-framed messaging on the health benefits of reducing alcohol intake, and alcohol harm-reduction / behaviour change strategies (e.g. drink counting, goal setting, behaviour substitution, problem solving).

Post-session information will be provided via email (i.e. electronic brochure summarising brief alcohol intervention content).

BEHAVIORAL: Lifestyle health promotion
Lifestyle health promotion, focused on physical activity and maintaining a healthy weight for reducing breast cancer risk, will be provided.

Post-session information will be provided via email (i.e. electronic brochure summarising nutrition for maintaining a healthy weight).
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Drinking intentions
Timepoint [1] 0 0
immediately post-randomisation
Secondary outcome [1] 0 0
Drinking intentions
Timepoint [1] 0 0
4-weeks post-randomisation
Secondary outcome [2] 0 0
Drinking intentions - standard drinks
Timepoint [2] 0 0
4-weeks post-randomisation
Secondary outcome [3] 0 0
Proportion of participants intending to reduce alcohol consumption
Timepoint [3] 0 0
immediately post-randomisation
Secondary outcome [4] 0 0
Proportion of participants intending to reduce alcohol consumption
Timepoint [4] 0 0
4-weeks post-randomisation
Secondary outcome [5] 0 0
Knowledge of alcohol as a breast cancer risk factor
Timepoint [5] 0 0
4-weeks post-randomisation
Secondary outcome [6] 0 0
Alcohol literacy
Timepoint [6] 0 0
4-weeks post-randomisation
Secondary outcome [7] 0 0
Alcohol consumption
Timepoint [7] 0 0
4-weeks post-randomisation
Secondary outcome [8] 0 0
Knowledge of other breast cancer risk factors
Timepoint [8] 0 0
4-weeks post-randomisation

Eligibility
Key inclusion criteria
* Female
* 40+ years of age
* Attending routine breast screening
* With or without a breast cancer history
* Reporting any level of alcohol consumption
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Not able to read or comprehend English to enable participation
* No access to a computer, tablet or smartphone to complete follow-up assessment
* Women who are pregnant (also an exclusion from breast screening)
* Participation in the pilot Health4Her trial

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
NA
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
1/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2023
Sample size
Target
Accrual to date
Final
143
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
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
BreastScreen Victoria
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Lifepool
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Shades of Pink
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jasmin Grigg, PhD
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is not Ethics approval to seek patient permission to share data outside this study.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06019442