Table 1.
Questionnaire/CRF | Time point for completion |
---|---|
Eligibility checklist | Baseline |
Comorbidity form | End of study |
Consent form | Baseline |
Registration/randomisation form | Baseline |
Baseline: clinical data form | End of study |
Clinical process measures Number of hospital contacts Number of alerts and hospital admissions Readmissions (with reasons) Clinician records of CTCAE and RTOG Changes to supportive medications and RT and/or chemotherapy dose changes Contacts with GP/community services Safety monitoring acute admissions, cumulative deaths |
Collected during a course of RT treatment and if appropriate chemotherapy cycle (from hospital records and via brief patient survey at routine clinic appointments for interim assessment of clinical contacts) |
IT system functioning Telephone log of phone calls from patients Record of unscheduled server down time |
Throughout the duration of the study |
Death and withdrawal form | At point of death/withdrawal |