Table 2.
Fatigue sub-scales of the MFI20 and quality of life (EORTC QLQ-C30) in the intention-to-treat population.
| Baseline (T0) | End of CT (T1) | End of RT (T2) | 1 Year after Inclusion (T3) | LMM Coefficients 1 (95% CI) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | SD | Mean | SD | p | Mean | SD | p | Mean | SD | p | |||
| General fatigue (Endpoint) | Control | 9.63 | 4.2 | 12.19 | 4.21 | 0.683 | 10.79 | 4.44 | 0.107 | 10.58 | 3.84 | 0.231 | β1 = 0.33 [−0.40; 1.07], p = 0.374 |
| APAD | 9.95 | 4.18 | 11.97 | 4.37 | 11.65 | 4.44 | 11.1 | 4.07 | β0 = 0.24 [0.014; 0.034], p < 0.05 | ||||
| Median (range) of the relative difference 2 | Control | 0.25 (−0.67; 3.0) | 0.083 (−0.60; 3.50) | 0.20 (−0.69; 3.5) | |||||||||
| APAD | 0.21 (−0.5; 2.75) | 0.20 (−0.58; 3.25) | 0.15 (−0.6; 3.0) | ||||||||||
| p = 0.274 | p = 0.157 | p = 0.933 | |||||||||||
| Physical fatigue | Control | 9.55 | 3.72 | 11.28 | 4.05 | 0.896 | 10.61 | 3.96 | 0.985 | 10.1 | 3.63 | 0.742 | β1 = −0.15 [−0.81; 0.52], p = 0.670 |
| APAD | 9.11 | 3.85 | 11.33 | 4.19 | 10.64 | 4.25 | 10.06 | 3.77 | β0 = 0.02 [0.007; 0.025], p < 0.05 | ||||
| Mental fatigue 3 | Control | 7.66 | 3.81 | 9.19 | 4.26 | 1 | 8.9 | 4.31 | 1 | 8.82 | 4.26 | 0.872 | β2 = −0.015 [−0.035; 0.005], p = 0.152 |
| APAD | 8.57 | 4.07 | 9.15 | 4.24 | 9.06 | 4.71 | 9.06 | 4.65 | β0 = 0.03 [0.013; 0.042], p < 0.05 | ||||
| Reduced activities | Control | 8.34 | 3.64 | 10.12 | 4.26 | 0.466 | 9.14 | 3.92 | 0.433 | 8.75 | 4.02 | 0.743 | β1 = 0.30 [−0.40; 0.99], p = 0.399 |
| APAD | 9.01 | 4.01 | 9.84 | 4.64 | 9.67 | 4.49 | 8.9 | 4 | β0 = 0.004 [−0.005; 0.014], p = 0.402 | ||||
| Reduced motivation 3 | Control | 7.73 | 3.5 | 8.22 | 3.92 | 0.587 | 7.84 | 3.46 | 0.651 | 8.07 | 3.19 | 0.572 | β1 = −0.30 [−0.34; 0.93], p = 0.360 |
| APAD | 8.54 | 3.73 | 8.31 | 3.7 | 8.15 | 3.77 | 8.1 | 3.83 | β0 = 0.002 [−0.006; 0.009], p = 0.696 | ||||
| EORTC QLQ-C30 | |||||||||||||
| Global health status | Control | 69.94 | 18.67 | 59.39 | 21.22 | 0.516 | 66.55 | 19.53 | 0.429 | 67.44 | 19.3 | 0.537 | β1 = −0.0026 [−0.071; 0.065], p = 0.940 |
| APAD | 68.45 | 19.55 | 60.83 | 21.34 | 64.82 | 19.1 | 69.17 | 17.76 | β0 = 0.001 [−0.001; 0.001], p = 0.824 | ||||
| Physical functioning | Control | 87.17 | 14.59 | 79.79 | 19.1 | 0.219 | 84.4 | 15.38 | 0.083 | 85.45 | 17.26 | 0.194 | β1 = −0.020 [−0.034; 0.075], p = 0.466 |
| APAD | 88.48 | 14.64 | 82 | 19.58 | 86.49 | 17.11 | 89.46 | 12.95 | β0 = −0.0001 [−0.0007; 0.0006], p = 0.873 | ||||
| Role functioning | Control | 84.46 | 22.16 | 77.99 | 23.34 | 0.257 | 84.35 | 21.03 | 0.966 | 87.05 | 18.48 | 0.309 | β1 = 0.026 [−0.073; 0.125], p = 0.607 |
| APAD | 86.57 | 20.4 | 80.63 | 23.25 | 83.8 | 22.01 | 90.05 | 16.86 | β0 = 0.0009 [−0.0005; 0.0022], p = 0.220 | ||||
| Emotional functioning | Control | 63.7 | 23.52 | 72.75 | 24.83 | 0.211 | 75.51 | 23.09 | 0.309 | 73.26 | 20.1 | 0.679 | β1 = 0.007 [−0.106; 0.119], p = 0.910 |
| APAD | 63.66 | 23.95 | 70.5 | 22.93 | 73.1 | 23.28 | 73.21 | 23.33 | β0 = 0.004 [0.002; 0.005], p < 0.01 | ||||
| Cognitive functioning | Control | 85.21 | 20.5 | 79.3 | 25.14 | 0.657 | 80.16 | 21.75 | 0.849 | 79.97 | 23.42 | 0.957 | β1 = −0.019 [−0.114; 0.076], p = 0.695 |
| APAD | 84.17 | 20.32 | 78.56 | 24.37 | 79.58 | 22.4 | 80.24 | 23.12 | β0 = −0.002 [−0.004; −0.001], p < 0.01 | ||||
| Social functioning | Control | 82.58 | 24.15 | 66.77 | 30.63 | 0.827 | 73.58 | 27.71 | 0.23 | 82.04 | 23.99 | 0.849 | β1 = 0.003 [−0.128; 0.134], p = 0.964 |
| APAD | 84.45 | 21.97 | 66.44 | 29.73 | 69.84 | 28.42 | 83.6 | 21.78 | β0 = −0.00008 [−0.002; 0.002], p = 0.942 | ||||
| Fatigue symptom | Control | 28.54 | 21.86 | 44.87 | 27.24 | 0.934 | 34.62 | 25.73 | 0.152 | 32.26 | 21.96 | 0.935 | β1 = −0.042 [−0.248; 0.164], p = 0.687 |
| APAD | 28.49 | 23.35 | 45.38 | 29.13 | 37.4 | 23.8 | 31.63 | 21.15 | β0 = 0.004 [0.001; 0.007], p = 0.018 | ||||
1 In the linear mixed model (LMM; log transformed variables): β1 is the coefficient of the variable ‘arm’ (interpreted as APAD effect with respect to Control) noted as β2 when interaction (arm by time) was significant. β0 is the coefficient of the variable time (weeks) variable. 2 For each patient, the relative difference (RD) with respect to the baseline value of the General fatigue subscale at the end of chemotherapy (CT), end of radiotherapy (RT; end of the oncological treatment), and 1 year after inclusion was calculated as: (GFS_endRT − GFS_Inclusion)/GFS_Inclusion. A smaller RD indicates a greater reduction in general fatigue. 3 A baseline imbalance between arms was observed for Mental fatigue (p = 0.019) and Reduced motivations (p = 0.025). No other baseline imbalance was observed.