JMIR Publications

ABSTRACT

Background:

Alcohol consumption is a major modifiable risk factor for breast cancer in women, even in small amounts, yet awareness of this risk remains low. National breast screening programs are uniquely positioned to provide timely and targeted health information and behavior-change strategies to improve women’s alcohol literacy and reduce consumption. A breast screening service is a novel healthcare setting for implementing an alcohol brief intervention, with potential for extensive reach.

Objective:

This research aimed to i) conduct a formative evaluation with breast screening service consumers to understand the need for, and acceptability of, an alcohol brief intervention in the breast screening setting, and collaboratively design an alcohol brief intervention (Health4Her) with women for this setting; ii) test the effectiveness of Health4Her in improving knowledge of alcohol as a breast cancer risk factor (primary outcome), improving alcohol literacy and reducing consumption among women attending a breast screening service; and iii) examine the implementation strategy through process evaluation.

Methods:

This was a hybrid type II effectiveness-implementation trial comprising a randomized controlled trial alongside a mixed-methods program evaluation guided by applicable elements of the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework and Consolidated Framework for Implementation Research (CFIR). The mixed-methods formative evaluation comprised a retrospective analysis of alcohol consumption data from breast screening service consumers (n=49,240), and an online survey (n=391) and focus groups/interviews (n=31) with subsets of breast screening service consumers. Women attending routine mammography, drinking at any level, were recruited to the single-site, double-blind randomized controlled trial (n=558), and completed a baseline assessment before being randomized (1:1) to receive Health4Her (alcohol brief intervention + lifestyle information) or control (lifestyle information) via an animation on an iPad. Follow-up assessments occurred at 4- and 12-weeks post-randomization. The mixed-methods process evaluation of trial administrative data, participant quantitative feedback (all trial participants completing 12-week assessment, n=497), participant qualitative feedback (n=30) and site staff qualitative feedback (n=11), was conducted to examine the factors affecting intervention implementation.

Results:

The research was funded in March and May 2019. Data collection for the formative evaluation occurred January-April 2020. Trial recruitment occurred February-August 2021, with follow-up data collection finalized in December 2021. Quantitative program evaluation data was collected during trial implementation and participant/staff feedback was collected November-December 2021. Data analyses are currently underway.

Conclusions:

This research is anticipated to generate significant new knowledge on the alcohol consumption and alcohol literacy needs of women attending for breast screening, and the extent to which these can be addressed using a novel, tailored alcohol brief intervention. This study will evaluate both the implementation and effectiveness of the Health4Her intervention, to inform expansion of this intervention into other breast screening services. Clinical Trial: ClinicalTrials.gov, NCT04715516. Pre-registered 20 January 2021.