Table 3 Summary of assessments and timing
Assessment | Source | Method of completion | Timeline | |||
|---|---|---|---|---|---|---|
Screening | Baseline | 3 months | 6 months (for patients recruited at least 3 months prior to the planned end of recruitment) | |||
PARTICIPANT | ||||||
Screening | Screening CRF | Research nurse/delegate | X | |||
Contact details | CRF | Research nurse/delegate | X | CTRU to be notified of address changes | ||
Demographics including comorbidities (Charlson Comorbidity Index) | CRF | Self-completion/research nurse/delegate | X | |||
Eligibility (including inclusion and exclusion criteria) | CRF | PI/research nurse/pis delegate | X | |||
Consent | Consent Form | Self-completion/RN/delegate over the telephone | X | |||
Randomisation | CRF/CTRU Online system | Research nurse/delegate | X | |||
ASK-12 | Questionnaire | Self-completion | X | X | X | |
McGill Quality of Life-Revised | Questionnaire | Self-completion | X | X | X | |
Work and Social Adjustment Scale | Questionnaire | Self-completion | X | X | X | |
HFRDIS | Questionnaire | Self-completion | X | X | X | |
MAF | Questionnaire | Self-completion | X | X | X | |
PROMIS Pain Interference | Questionnaire | Self-completion | X | X | X | |
DIVA (Part C) | Questionnaire | Self-completion | X | X | X | |
GAD-7 | Questionnaire | Self-completion | X | X | X | |
PHQ-9 | Questionnaire | Self-completion | X | X | X | |
FACT-ES | Questionnaire | Self-completion | X | X | X | |
Valuing Questionnaire (VQ) | Questionnaire | Self-completion | X | X | X | |
UK Cancer Costs | Questionnaire | Self-completion | X | X | X | |
Acceptability | Questionnaire | Self-completion | X | |||
B & N Questionnaire | Questionnaire | Self-completion | X | |||
Safety Reporting | CRF | Research nurse/PI/delegate/self-completion | X | |||
Usual Care Data | CRF | Researcher/delegate/self-completion | X | X | X | |