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Table 1 PRO-ACTIVE Schedule of Activities

From: The PRO-ACTIVE trial protocol: a randomized study comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer

  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
  1. (X) Only for untriggered RE-ACTIVE arm participants
  2. XX Only for Triggered RE-ACTIVE Arm 1, PRO-ACTIVE EAT and PRO-ACTIVE EAT + EXERCISE Arm 3 participants
  3. X* Only for Triggered RE-ACTIVE Arm 1 and PRO-ACTIVE EAT + EXERCISE Arm 3 participants
  4. a X-Ray involved. Requires central lab review
  5. b randomization completed within 72 h of eligibility verification by completion of central VFS review
  6. c Per chart abstraction by coordinator; if missing in chart, by coordinator contact
  7. 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)
  8. e RT plan DICOM archived to central database
  9. 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
  10. g to be completed at select sites only
  11. h administered as part of MOD
  12. i completed at the end of RT
  13. j to be completed every 2 weeks for first 3 months after RT within ±3 days
  14. k to be completed monthly within ±7 days
  15. **Coordinator review of trigger status of RE-ACTIVE participants
  16. ***Participant review of PRO dependent trigger items (i.e. tube feed and MDASI #16 choke item)