Table 1.
PRO-ACTIVE Schedule of Activities
| Pre-RT | During RT | Post-RT | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 1 ±3 tx days |
Week 2 ±3 tx days |
Week 3 ±3 tx days |
Week 4 ±3 tx days |
Week 5 ±3 tx days |
Week 6 ±3 tx days |
3 Months ±2 weeks |
12 Months ±4 weeks |
||
| Time | 1 |
2 (randomization to 3 tx days after RT Start) |
3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Assessments (by chart abstraction and at clinic visits) and Protocol Procedures | ||||||||||
| Informed Consent | X | |||||||||
| Eligibility verification | X | |||||||||
| VFSa | X | X | X | |||||||
| Trismus | X | X | X | |||||||
| Randomizationb | X | |||||||||
| Demographics | X | |||||||||
| Medical Historyc | X | X | X | X | ||||||
| BMI | X | X | X | X | X | X | ||||
| PSS-HNd | X | X | X | X | X | X | ||||
| RT plan archivee | Xi | |||||||||
| AESI | X | X | X | X | X | |||||
| Pain Medications | X | X | X | X | ||||||
| Trigger Review** | (X) | (X) | (X) | (X) | (X) | (X) | ||||
| Swallowing Therapy | ||||||||||
| Swallowing Therapy Sessionsf | X | X | X | X | ||||||
| Patient Reported Outcomes (does not require clinic visits) | ||||||||||
| Trigger PRO*** | (X) | (X) | (X) | (X) | (X) | (X) | ||||
| MDADI | X | Xi | X | X | ||||||
| Tube PRO | X | XX | XX | XX | Xj | Xk | ||||
| MDASI-HN | X | X | X | X | X | X | ||||
| Exercise Diary | X* | X* | X* | X* | X* | X* | X | X | ||
| MODg | X | X | X | |||||||
| Self-Report Pneumoniah | X | X | X | |||||||
| CBI-I | X | X | X | |||||||
| EQ-5D-5L | X | X | X | |||||||
(X) Only for untriggered RE-ACTIVE arm participants
XX Only for Triggered RE-ACTIVE Arm 1, PRO-ACTIVE EAT and PRO-ACTIVE EAT + EXERCISE Arm 3 participants
X* Only for Triggered RE-ACTIVE Arm 1 and PRO-ACTIVE EAT + EXERCISE Arm 3 participants
a X-Ray involved. Requires central lab review
b randomization completed within 72 h of eligibility verification by completion of central VFS review
c Per chart abstraction by coordinator; if missing in chart, by coordinator contact
d Validated clinic interview along with study specific questions administered by SLP/Clinician (or by a research coordinator if no clinic visits or missed in clinic)
e RT plan DICOM archived to central database
f Conducted by Speech Language Pathologist and only for participants assigned to PRO-ACTIVE arms. Participants in RE-ACTIVE arms who are triggered will begin swallowing therapy according to the EAT-EXERCISE model in arm 3 (PRO-ACTIVE EAT + EXERCISE) within 3 treatment days
g to be completed at select sites only
h administered as part of MOD
i completed at the end of RT
j to be completed every 2 weeks for first 3 months after RT within ±3 days
k to be completed monthly within ±7 days
**Coordinator review of trigger status of RE-ACTIVE participants
***Participant review of PRO dependent trigger items (i.e. tube feed and MDASI #16 choke item)