Table 2.
Standard Protocol Items: Recommendations for Interventional Trials schedule of enrollment, interventions, and assessments.
|
|
Time point | ||||||
|
|
Baseline (Maroondah BreastScreen) | Follow-up (telephone) | Follow-up (telephone) | ||||
|
|
Day 1 | 4 weeks | 12 weeks | ||||
| Enrollment | |||||||
|
|
Verbal information and provision of trial information sheet | ✓ |
|
|
|||
|
|
Informed consent (written or verbal; time-dependent) | ✓ |
|
|
|||
|
|
Eligibility and demographic information | ✓ |
|
|
|||
|
|
Randomization | ✓ |
|
|
|||
| Intervention | |||||||
|
|
Active condition: Health4Her alcohol brief intervention + lifestyle information | ✓ |
|
|
|||
|
|
Control condition: lifestyle information | ✓ |
|
|
|||
| Assessmenta | |||||||
|
|
Knowledge assessment of breast cancer risk factors, including alcohol | ✓ | ✓ b |
|
|||
|
|
14-day timeline follow-back [45] | ✓ | ✓ | ✓ | |||
|
|
Australian Institute of Health and Welfare alcohol frequency and quantity items [46,47] | ✓ | ✓ | ✓ | |||
|
|
Assessment of alcohol literacy | ✓ | ✓ |
|
|||
|
|
European Health Interview Survey-Quality of Life (single item) [50] | ✓ | ✓ | ✓ | |||
|
|
Short Form Health Survey [49] | ✓ | ✓ | ✓ | |||
|
|
Assessment of physical activity [51] and fruit and vegetable consumption [52] | ✓ | ✓ | ✓ | |||
aAlcohol assessments were nested among general health and lifestyle questions to conceal alcohol focus.
bPrimary outcome.