Table 1.
Schedule of Assessments
| Standard 2-6 month intravenous chemotherapy treatment; total 9 months study follow up | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lead-in | BL | W2 | W3 | W4 | W5 | W6 | W7 | W8 | M3 | M4 | M5 | M6 | M7 | M8 | M9 | ** | |
| Clinician- reported ECOG * | X | ||||||||||||||||
| Symptomatic AE (PRO-CTCAE) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
| FACT GP5 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
| PGI-S | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
| PROMIS Physical Function SF 8c | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
| EORTC QLQ-F17 Role Function only | X | X | X | X | X | X | X | ||||||||||
| PRO-ECOG | X | X | X | X | X | X | X | X | X | X | X | X | |||||
| EORTC QLQ-F17 | X | X | X | X | X | ||||||||||||
| PGI-C | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
| 6MWT † | X | X | |||||||||||||||
| Exit Questionnaire | X | ||||||||||||||||
| Wearable Data | X¥-> | Continuous wearable data throughout | |||||||||||||||
BL – baseline, W - week, M – month;
*
at baseline (CRA to ensure ECOG is recorded at baseline by clinical provider), and where available at follow up
**
- context dependent long-term follow-up
†
6MWT at baseline and at M3 will be performed in clinic (with CRA) for patients treated at primary sites available for assessment. The window for the M3 6MWT assessment is anytime during the 3rd month.
¥
Lead-in time period of at least 24 hours prior to initiation of cancer-directed treatment
Highlighted time points are “high yield” time points for reminders and will include CRA phone calls to patient if PROs have not been completed