Table 4.
Study flowchart.
Procedure/evaluation | Randomization | Continuous
(up to 24 months from study entry) |
Months +6, +12, +18, +24
( ± 2 weeks) |
---|---|---|---|
Informed consent | ✓ | ||
Baseline evaluation | ✓ | ||
Randomization | ✓ | ||
Demographics | ✓ | ||
Concomitant medications and medical events review | ✓ | ✓ | |
Clinical data retrieval (stage, pathology, HPV status) | ✓ | ||
Physical/emotional/social monitoring apps | ✓ | ✓* | ✓ |
QoL questionnaires | ✓ | ✓ |
*for intervention arm only.