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

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
VFS^a	X								X	X
Trismus	X								X	X
Randomization^b		X
Demographics	X
Medical History^c	X							X	X	X
BMI	X			X		X		X	X	X
PSS-HN^d	X			X		X		X	X	X
RT plan archive^e								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 Sessions^f		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	X^j	X^k
MDASI-HN	X			X		X		X	X	X
Exercise Diary			X*	X*	X*	X*	X*	X*	X	X
MOD^g	X								X	X
Self-Report Pneumonia^h	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)

ISSN: 1471-2407