Table 1 Trial-related assessments and time points (both arms)
Baseline measures (week 0) | Midpoint (week 5) | Endpoint (week 9) | |
|---|---|---|---|
Demographics | • Gender, primary tumour site and tumour status; metastatic sites; current hormone/bisphosphonate or steroid treatment | • N/A | • N/A |
Physical measures | • Height • Weight | • Weight | • Weight |
Quality of life (QOL) measures | • Patient QOL (EORTC QLQ-C15-PAL questionnaire) [24] • Partner-Carer QOLa (Caregiver Quality of Life Index-Cancer Questionnaire (CQOLC)) [25] • EQ-5D-5L & EQ-VAS [26] questionnaires | • Patient QOL (EORTC QLQ-C15-PAL) • Partner-Carer QOLa (CQOLC) • EQ-5D-5L & EQ-VAS questionnaires | • Patient QOL (EORTC QLQ-C15-PAL) • Partner-Carer QOLa (CQOLC) • EQ-5D-5L & EQ-VAS questionnaires |
Functional measures | • Karnofsky Performance Status (KPS) [27] • Life Space Assessment questionnaire (LSA) [28] • Two-minute walk test [29] • Timed up and go test [30] | • KPS • LSA • Two-minute walk test • Timed up and go test | • KPS • LSA • Two-minute walk test • Timed up and go test |
Socio-economic measures | • Socio-economic background (employment status, benefits received, carer responsibilities, current use of social services) • Healthcare utilisation and expenses questionnaire | • Healthcare utilisation and expenses questionnaire | • Healthcare utilisation and expenses questionnaire |
Physical activity meter (PAM) | • PAM worn continuously for 7 daysb (data retrieved at week 1) • Mean daily step count • Hours asleep/ restless/ awake per night | (PAM worn only at baseline and end point) | • PAM worn continuously for 7 daysb (data retrieved at week 10) • Mean daily step count • Hours asleep/restless/awake per night |
Nutritional measures | • Abridged Patient-Generated Subjective Global Assessment (aPG-SGA) [31] • Ten-point verbal analogue scale (AveS) [32] | • aPG-SGA • AveS | • aPG-SGA • AveS |