Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial

Table 2 Study assessments at specific time points

			Study Period
	Staff member	Pre-study screening/consent	Baseline	Allocation	Post-allocation
Time point			Week -3	Week 0	Week 1	Week 8	Week 24
ENROLMENT
Eligibility screen	Interviewer	X
Informed consent	Interviewer	X
Allocation	Study Coordinator			X
INTERVENTIONS
Shape-up	Interviewer
Usual care	Interviewer
ASSESSMENTS
Socio-demographic data	Interviewer		X
EORTC-QLQ-C30	Interviewer		X			X	X
EORTC-QLQ-EN34	Interviewer		X			X	X
Dietary assessment	Interviewer		X			X	X
Physical activity	Interviewer		X			X	X
Weight	Interviewer		X			X	X
Height	Interviewer		X
Body composition	Interviewer		X			X	X
Waist circumference	Interviewer		X			X	X
Hand-grip strength	Interviewer		X			X	X
Blood pressure	Interviewer		X			X	X
Shape Up evaluation	Interviewer					X ²	X ²
Control group input	Interviewer						X³
Qualitative interviews	Interviewer					X	X
Health care resource use	Interviewer						X
EQ5D-3 L	Interviewer		X			X	X
Serious adverse report form	Study Coordinator	As needed throughout the protocol

¹Closeout for the control group will be at week 40 after receiving the intervention
²Only the intervention group
³Only in the control group

ISSN: 1745-6215