Table 1.
Outcomes | Assessment measure | Pre CRT | Mid chemo-CRT | Mid CRT | Week 0 | Week 3 | Week 6 | Week 9 | Day 3 post-surgery | Day 5 post-surgery | Day 8 post-surgery | Day 15 post-surgery | 6 Weeks post-surgery |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Primary endpoint | |||||||||||||
Oxygen uptake at lactate threshold | CPET | X | UHS only | X | X | X | X | ||||||
Secondary endpoint | |||||||||||||
Health-related quality of life | Questionnaires: EORTC QLQ-30, EQ-5D | X | UHS only | X | X | X | X | X | X | ||||
Semi-structured interviews | X | X | |||||||||||
Physical activity | SenseWear accelerometer | X | UHS only | X | X | X | X | X | |||||
Exploratory endpoint | |||||||||||||
Post-operative morbidity | POMS | X | X | X | X | ||||||||
Cancer staging | MR pelvis mrTRG | X | X | ||||||||||
X |
Abbreviations: CRT chemoradiotherapy, CPET cardiopulmonary exercise test, UHS University Hospital Southampton, POMS Post- operative morbidity score, mrTRG magnetic resonance tumour regression grade, MR magnetic resonance