Table 3.
Standard Protocol Items: Recommendations for Interventional Trials schedule of enrollment, interventions, and assessments.
| Data collected | Method | |||
| Screening | ||||
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Eligibility and demographic information | Brief standard demographic characteristics (eg, age and education) and inclusion and exclusion information collected through structured questions. | ||
| Primary outcome | ||||
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Knowledge assessment of breast cancer risk factors | Participants were asked to demonstrate their knowledge of breast cancer risk associated with 6 factors (eg, family history of breast cancer, physical inactivity, antiperspirant deodorant use, alcohol, processed meats, and excess weight) by selecting from a set of scaled-response options: (1) a clear breast cancer risk factor with strong, consistent evidence; (2) a possible risk factor with some evidence; (3) not a proven risk factor with too limited evidence to determine risk; or (4) do not know. Primary outcome was the proportion of participants identifying alcohol as a clear breast cancer risk factor at 4 weeks. Adapted from Cancer Australia’s 2018 definitions of breast cancer risk factors and previous research with breast screening service consumers [48,53]. | ||
| Secondary outcomes | ||||
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|
Alcohola | |||
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14-day TLFBb | Alcohol consumption over past 14 days assessed with TLFB [45]. TLFB also informed personalized feedback provided in the alcohol brief intervention. | |
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AIHWc alcohol frequency and quantity items | Past-month frequency of alcohol consumption and volume of alcohol consumption on a typical drinking day assessed with 2 items from the AIHW National Drug Strategy Household Survey [46,47]. | |
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Assessment of alcohol health literacy | Adapted from previous research with breast screening service consumers, participants were asked about (1) attitudes to alcohol and breast cancer risk [48]; (2) alcohol health knowledge (eg, amount of alcohol in a standard drink, number of standard drinks in an average restaurant serve of alcohol, maximum number of standard drinks recommended by current health guidelines) [10]; and (3) access to alcohol and breast cancer health information [54]. Questions were presented in multiple-choice, open-ended, or statement (ie, 5-point Likert scale from strongly agree to strongly disagree) formats. | |
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|
Health and well-being | |||
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European Health Interview Survey-QOLd single item | QOL rated as single item on 5-point Likert scale from very poor to very good [50]. | |
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SF-12e | SF-12 used as a brief measure of general health [49]. | |
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Physical activity duration [51,52] and consumption of vegetables and fruit [52] | Brief physical activity and vegetable and fruit intake questions included to ensure blinding of participants. Questions adapted from the Australian Bureau of Statistics and previous research [51,52]. | |
aAlcohol assessments were nested among general health and lifestyle questions to conceal the trial’s alcohol focus.
bTLFB: timeline follow-back.
cAIHW: Australian Institute of Health and Welfare.
dQOL: quality of life.
eSF-12: 12-item Short-Form Health Survey.