Table 1 Primary and secondary outcomes

Primary outcome

 Fatigue score

Standardised T-metric score at 6 months. Higher scores represent more fatigue burden.

Secondary outcomes

 Need of hospitalisations and emergency room visits

A cumulative number of hospital admissions and number of emergency room visits at 6 and 12 months.

 Physical functioning score

Standardised T-metric score at 6 and 12 months. Higher scores indicate higher levels of functioning.

 Fatigue score

Standardised T-metric score at 12 months. Higher scores represent more fatigue burden.

 Overall survival

Time to death (in months).

 HRQoL score

Standardised T-metric score at 6 and 12 months. Higher scores indicate higher levels of HRQoL.

 Time to first systemic therapy change

Time to first systemic therapy change (in months) after randomisation.