Study assessments and outcome evaluations
T0 | P1 | T1 (W6) | P2 | T2 (W12) | |||||||||||
Inclusion D−30 to D0 | W1 | W2 | W3 | W4 | W5 | W6 | End of period 1 evaluation | W1 | W2 | W3 | W4 | W5 | W6 | End of period 2 evaluation/end of study visit | |
Inclusion/non-inclusion criteria | X | ||||||||||||||
Informed signed consent | X | ||||||||||||||
Patient inclusion | X | ||||||||||||||
Randomisation | X | ||||||||||||||
Medical history | X | ||||||||||||||
Physiotherapy check-ups (including NRPS) | X | X | X | ||||||||||||
Educational check-ups (experimental group only) | X | X | X | ||||||||||||
Questionnaires (GSES, EORTC QLQ-C30 and BR23, HADS, SF-36, BPI) | X | X | X | ||||||||||||
Blood sample | X | X | |||||||||||||
Reminder email (experimental group only) | X | X | |||||||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Pain treatments | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Supervised yoga session (experimental group only) | One 90 min supervised yoga session/ week | ||||||||||||||
At-home yoga practice (experimental group only) | One daily 15 min at-home session | One daily 15 min at-home session |
BPI, Brief Pain Inventory; D, day; EORTC QLQ-C30 and BR23, European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire of Cancer Patients and Breast cancer-specific module; GSES, General Self-Efficacy Scale; HADS, Hospital Anxiety and Depression Scale; NRPS, Numeric Pain Rating Scale; SF-36, 36-Item Short Form Health Survey; W, week.