Data collection schedule
Data | Baseline | Inpatient predischarge | Intervention period | 6* months postrandomisation | 12* months postrandomisation |
Age (years) | √ | ||||
Gender | √ | ||||
Weight (kg)/(stone/lbs) | √ | ||||
Height (cm)/(ft/inches) | √ | ||||
Ethnicity | √ | ||||
Drinking status | √ | ||||
Smoking status | √ | ||||
Primary cancer site | √ | ||||
Stage of tumour | √ | ||||
Neck nodal status | √ | ||||
Pre-existing shoulder or neck musculoskeletal disorder | √ | ||||
Hand dominance | √ | ||||
AMTS | √ | ||||
List of medical co-morbidities | √ | ||||
Employment status and current occupation (when appropriate) | √ | √ | √ | ||
Shoulder Pain and Disability Index | √ | √ | √ | ||
Numerical rating scale pain | √ | √ | √ | ||
EQ-5D-5L | √ | √ | √ | ||
EORTC QLQ-C30 | √ | √ | √ | ||
EORTC QLQ-H&HN43 | √ | √ | √ | ||
Physical performance measures | √ | √ | √ | ||
Pain relief medication list | √ | √ | √ | ||
Complications, AE, SAE details of accident and emergency attendances and hospital admissions | √ | √ | √ | √ | |
Operation date | √ | ||||
Operative procedure (level of ND) | √ | ||||
Location of HNC | √ | ||||
Accessory nerve sacrificed | √ | ||||
ASA grade | √ | ||||
Pathology results | √ | ||||
Preoperative cancer head and neck treatment | √ | ||||
Chemotherapy and radiotherapy treatment provision | √ | √ | √ | ||
Intervention fidelity and cross-over logs | √ | ||||
Physiotherapy intervention log (physiotherapist completed) | √ | √ | |||
Home exercise diary (participant completed) | √ | ||||
Health economic/health utilisation questionnaire | √ | √ |
*Each follow-up interval±1 month.
EORTC, European Organisation for Research and Treatment of Cancer; HNC, head and neck cancer; ND, neck dissection.