Participant assessment (including who is involved) | Timeline (months postrandomisation) | |||
Baseline | 1 | 3 | 6 | |
Eligibility and consent | ||||
Consent (P, C, R) | X | |||
Eligibility (assessed by clinician, R) | X | |||
Background and demographics | ||||
General demographics (P, C, R) | X | |||
Cancer demographics (R-case notes) | x | |||
Comorbidities (R-case notes) | X | |||
Follow-up data (collected from case notes) | ||||
Survival status (R) | Ongoing and at the overall end of the trial | |||
Related unexpected serious adverse events (R) | Ongoing | |||
NAT-C Intervention (R) | One month post participant registration | |||
Usual care data (R) | X | X | X | X |
Prequestionnaire (phone call at 1, 3, 6 months) | ||||
Performance status (AKPS) | x | x | x | x |
COVID status | x | x | x | x |
Participant Questionnaire Booklet | ||||
(Self-completion with researcher support if needed) | ||||
Unmet needs (SCNS-SF34) | x | x | x | x |
Symptoms (ESAS-r) | x | x | x | x |
Mood and Quality of Life (EORTC QLQ-C15-PAL) | x | x | x | x |
EuroQol-5 Dimension L (EQ-5D-5L) | x | x | x | x |
ICECAP-SCM | x | x | x | x |
Healthcare Resource Use (including usual care data and referrals) | x | x | x | x |
Carer Questionnaire Booklet | ||||
(Self-Completion with researcher support if needed) | ||||
Carer Experience Scale | x | x | x | x |
Carer well-being and burden (ZBI-12) | x | x | x | x |
*P, participant; C, carer-giver; R, researcher.
AKPS, Australian-modified Karnofsky Performance Status; EORTC QLQ-C15-PAL, European Organisation for Research and Treatment of Cancer Quality of Life-C15-Palliative; EQ-5D-L, EuroQol-5 Dimension L ; ICECAP-SCM, ICEpop CAPability Supportive Care Measure; NAT-C, Needs Assessment Tool-Cancer; SCNS-SF34, Supportive Care Needs Survey Short Form 34; ZBI-12, Zarit Burden Interview-12.