Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial)

Table 2 Data collection at the different time points in the NUTRI-HAB trial

	TIMEPOINT
	Baseline	3-month follow-up	6-month follow-up
DEMOGRAPHIC DATA
Register-based information
- Age	X
- Gender	X
- Cancer diagnosis	X
- Time interval since treatment	X
Self-reported information
- Civil status	X
- Educational level	X
- Occupational status	X
- Current cancer status	(X)	(X)	(X)
- Participation in other rehabilitation services	(X)	(X)	(X)
NUTRITIONAL RISK AND PRESENCE OF NUTRITION IMPACT SYMPTOMS
- NRS 2002	X	(X)	(X)
- PG-SGA SF	X	(X)	(X)
- MDADI	X	(X)	(X)
REHABILITATION NEEDS MEASURED BY THE REHPA SCALE
	(X)	(X)	(X)
PRIMARY OUTCOME
- Body weight	X	X	(X)
SECONDARY OUTCOMES
Patient-reported outcome measures
Quality of life
- EQ-5D-5 L	X	X	(X)
- EORTC QLQ-C30	X	X	(X)
- EORTC QLQ-H&N35	X	X	(X)
Symptoms of anxiety and depression
- HADS	X	X	(X)
Physical measurements and tests^a
- Body mass index	X	X	(X)
- Maximal mouth opening	X	X	(X)
- Hand grip strength	X	X	(X)
- 30-second chair stand test	X	X	(X)
- 6-minute walk test	X	X	(X)

X: Data will be collected for primary analyses, (X): Data will be collected for exploratory analyses
^aThe physical performance tests will be made in a standardised order as follows: 30-second chair stand test, hand grip strength, and 6-minute walk test
EORTC: European Organization for Research and Treatment of Cancer, HADS: Hospital Anxiety and Depression Scale, NRS 2002: Nutritional Risk Screening 2002, PG-SGA SF: The Scored Patient Generated Subjective Global Assessment Short Form, MDADI: M. D. Anderson Dysphagia Inventory

ISSN: 1475-2891