Table 4.
Questionnaire time points | p value | ||||||
---|---|---|---|---|---|---|---|
Baseline | Halfway CT | Before last cycle of CT | 6 months after surgery | Time | Randomization | Time by randomization | |
EORTC-QLQ-C30 | |||||||
Global Health | |||||||
Regular diet | 80.5 | 70.3 | 59.2 | 75.8 | <0.001 | 0.298 | 0.883 |
FMD | 79.5 | 71.2 | 61.5 | 78.7 | |||
Functioning scales | |||||||
Physical functioning | |||||||
Regular diet | 93.7 | 81.9 | 68.8 | 82.8 | <0.001 | 0.316 | 0.562 |
FMD | 96.4 | 84.0 | 77.0 | 86.2 | |||
Role functioning | |||||||
Regular diet | 90.1 | 66.1 | 52.4 | 74.1 | <0.001 | 0.392 | 0.653 |
FMD | 86.7 | 67.0 | 52.9 | 78.1 | |||
Emotional functioning | |||||||
Regular diet | 75.3 | 80.7 | 73.4 | 78.1 | 0.048 | 0.215 | 0.631 |
FMD | 69.9 | 80.2 | 78.4 | 80.0 | |||
Cognitive functioning | |||||||
Regular diet | 89.4 | 77.2 | 70.5 | 76.9 | 0.011 | 0.106 | 0.533 |
FMD | 84.2 | 80.3 | 75.5 | 74.8 | |||
Social functioning | |||||||
Regular diet | 92.0 | 74.9 | 62.8 | 83.6 | 0.005 | 0.467 | 0.724 |
FMD | 88.6 | 78.8 | 68.6 | 83.3 | |||
Symptoms | |||||||
Fatigue | |||||||
Regular diet | 19.0 | 39.8 | 52.8 | 31.1 | <0.001 | 0.154 | 0.393 |
FMD | 23.0 | 39.3 | 43.5 | 28.9 | |||
Nausea | |||||||
Regular diet | 4.3 | 15.5 | 5.9 | 2.5 | <0.001 | 0.629 | 0.312 |
FMD | 4.2 | 12.1 | 7.4 | 3.1 | |||
Pain | |||||||
Regular diet | 11.5 | 15.8 | 22.9 | 17.3 | <0.001 | 0.992 | 0.159 |
FMD | 7.6 | 8.5 | 25.5 | 20.0 | |||
Dyspnea | |||||||
Regular diet | 4.6 | 14.0 | 26.4 | 16.0 | 0.001 | 0.694 | 0.045 |
FMD | 3.7 | 20.6 | 20.6 | 9.6 | |||
Insomnia | |||||||
Regular diet | 26.4 | 26.9 | 37.5 | 38.3 | <0.001 | 0.068 | 0.246 |
FMD | 32.7 | 19.4 | 39.2 | 31.1 | |||
Appetite loss | |||||||
Regular diet | 9.8 | 17.5 | 29.9 | 7.4 | <0.001 | 0.196 | 0.535 |
FMD | 14.5 | 17.0 | 21.6 | 5.2 | |||
Constipation | |||||||
Regular diet | 2.3 | 25.1 | 22.2 | 8.0 | <0.001 | 0.654 | 0.826 |
FMD | 2.4 | 23.0 | 16.7 | 8.1 | |||
Diarrhea | |||||||
Regular diet | 6.9 | 7.0 | 10.4 | 1.2 | <0.001 | 0.623 | 0.749 |
FMD | 4.8 | 7.3 | 13.7 | 2.2 | |||
Financial difficulties | |||||||
Regular diet | 2.9 | 9.9 | 11.8 | 6.2 | 0.807 | 0.981 | 0.014 |
FMD | 3.8 | 8.5 | 5.9 | 14.1 | |||
EORTC-QLQ-BR23 | |||||||
Body image | |||||||
Regular diet | 89.9 | 78.8 | 65.1 | 78.4 | <0.001 | 0.466 | 0.366 |
FMD | 90.3 | 73.2 | 68.4 | 74.3 | |||
Sexual functioning | |||||||
Regular diet | 77.0 | 81.9 | 86.8 | 73.0 | <0.001 | 0.815 | 0.292 |
FMD | 76.1 | 78.5 | 86.3 | 75.8 | |||
Sexual enjoyment | |||||||
Regular diet | 58.1 | 44.4 | 43.1 | 55.9 | 0.001 | 0.554 | 0.040 |
FMD | 56.1 | 49.5 | 42.9 | 48.7 | |||
Future perspective | |||||||
Regular diet | 42.0 | 34.5 | 45.8 | 40.7 | 0.184 | 0.579 | 0.085 |
FMD | 47.9 | 40.1 | 37.3 | 38.5 | |||
Symptom scales | |||||||
Side effects of systemic therapy | |||||||
Regular diet | 10.5 | 32.8 | 40.0 | 18.5 | <0.001 | 0.378 | 0.817 |
FMD | 9.6 | 31.9 | 35.9 | 16.5 | |||
Upset by hair loss | |||||||
Regular diet | 16.7 | 32.6 | 31.1 | 50.0 | 0.003 | 0.465 | 0.187 |
FMD | 33.3 | 36.8 | 31.4 | 40.0 | |||
Distress thermometer | |||||||
Regular diet | 5.21 | 6.27 | 6.17 | 0.468 | 0.358 | 0.465 | |
FMD | 5.16 | 5.53 | 5.98 |
P-values < 0.05 were considered significant
P time changes of QoL scores over time, P randomization differences in QoL between the two treatment groups (FMD vs. regular diet), P time by randomization different effects between treatment groups over time, CT chemotherapy, FMD fasting mimicking diet.