Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer

Table 3 Data collection time point of all outcome measures and proposed mediators

Concept	Questionnaire	Measurement time points
Concept	Questionnaire	T0	T1	T2	T3
Socio-demographics	Self-report questionnaire	X
Medical characteristics	Medical chart review	X	X
Primary outcome:
Fatigue severity	CIS fatigue severity	X	X	X	X
Secondary outcomes:
Fatigue	EORTC QLQ-C30 fatigue	X	X	X	X
Quality of life	EORTC QLQ-C30 global health status	X	X	X	X
Functional impairments	SIP	X	X	X	X
	EORTC QLQ-C30 emotional functioning	X	X	X	X
	EORTC QLQ-C30 physical functioning	X	X	X	X
Proposed mediators:
Physical activity	Actigraphy during 12 consecutive days	X	X
Physical fitness	6MWT	X	X
Self-efficacy	SES	X	X
Fatigue catastrophising	FCS	X	X

T0 baseline (pre-intervention), T1 post-intervention/UC (14 weeks post-randomisation), T2 first follow-up assessment (18-weeks post-randomisation), T3 s follow-up assessment (26-weeks post-randomisation)

ISSN: 1471-2407