Table 5 Estimated mean changes (95% confidence intervals) in scores from baseline to 3, 6, 9, and 12 months
Health-related quality of life domains | 3 months | P | Size, direction | 6 months | P | Size, direction | 9 months | P | Size, direction | 12 months | P | Size, direction |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
EORTC-QLQ-C30 | ||||||||||||
Global health status | 0.74 (− 4.48 to 5.96) | 0.78 | Trivial | 6.61 (1.06–12.16) | 0.02 | Small improvement | 7.66 (1.84–13.48) | 0.01 | Small improvement | 6.39 (0.33–12.45) | 0.04 | Small improvement |
Physical functioning | − 2.39 (− 6.21 to 1.44) | 0.21 | Trivial | 0.22 (− 3.85 to 4.28) | 0.92 | Trivial | − 0.34 (− 4.63 to 3.95) | 0.87 | Trivial | 1.57 (− 2.87 to 6.00) | 0.48 | Trivial |
Role functioning | 1.52 (− 4.68 to 7.72) | 0.62 | Trivial | 2.94 (− 3.64 to 9.51) | 0.37 | Trivial | 5.20 (− 1.74–12.14) | 0.13 | Trivial | 4.40 (− 2.77–11.57) | 0.22 | Trivial |
Emotional functioning | 2.51 (− 1.53 to 6.55) | 0.21 | Trivial | 3.76 (− 0.53 to 8.06) | 0.08 | Trivial | 5.62 (1.11–10.12) | 0.01 | Small improvement | 2.26 (− 2.43 to 6.95) | 0.34 | Trivial |
Cognitive functioning | − 3.21 (− 7.26 to 0.84) | 0.11 | Small deterioration | 0.04 (− 4.28 to 4.36) | 0.99 | Trivial | − 2.15 (− 6.68 to 2.39) | 0.34 | Trivial | − 3.54 (− 8.26 to 1.18) | 0.14 | Small deterioration |
Social functioning | − 1.49 (− 6.63 to 3.64) | 0.56 | Trivial | 3.37 (− 2.09 to 8.83) | 0.22 | Small improvement | 2.01 (− 3.71 to 7.74) | 0.48 | Trivial | 5.18 (− 0.78–11.14) | 0.08 | Small improvement |
Fatigue | 0.88 (− 3.91 to 5.67) | 0.71 | Trivial | − 4.13 (− 9.22 to 0.95) | 0.11 | Small improvement | − 5.87 (− 11.24 to − 0.51) | 0.03 | Small improvement | − 4.83 (− 10.37 to 0.72) | 0.08 | Small improvement |
Nausea and vomiting | 1.61 (− 2.15 to 5.36) | 0.39 | Trivial | − 3.52 (− 7.47 to 0.44) | 0.08 | Small improvement | − 3.87 (− 8.03 to 0.29) | 0.06 | Small improvement | − 4.23 (− 8.53 to 0.06) | 0.05 | Small improvement |
Pain | − 2.06 (− 7.32 to 3.20) | 0.43 | Trivial | − 7.42 (− 13.00 to − 1.84) | 0.01 | Small improvement | − 8.10 (− 13.98 to − 2.22) | 0.01 | Small improvement | − 4.68 (− 10.76 to 1.40) | 0.12 | Trivial |
Dyspnea | 4.22 (− 0.93 to 9.38) | 0.10 | Trivial | − 0.41 (− 5.88 to 5.06) | 0.88 | Trivial | 5.15 (− 0.62–10.91) | 0.08 | Small deterioration | 2.61 (− 3.35 to 8.57) | 0.38 | Trivial |
Insomnia | 5.59 (− 1.02–12.21) | 0.09 | Small deterioration | 0.35 (− 6.65 to 7.36) | 0.92 | Trivial | − 0.74 (− 8.12 to 6.64) | 0.84 | Trivial | − 3.77 (− 11.41 to 3.86) | 0.32 | Trivial |
Appetite loss | − 2.41 (− 9.17 to 4.34) | 0.48 | Trivial | − 3.24 (− 10.41 to 3.94) | 0.37 | Trivial | − 6.16 (− 13.68 to 1.36) | 0.10 | Trivial | − 5.56 (− 13.34 to 2.22) | 0.15 | Trivial |
Constipation | 2.59 (− 2.25 to 7.43) | 0.29 | Trivial | − 2.00 (− 7.13 to 3.12) | 0.44 | Trivial | − 0.70 (− 6.13 to 4.74) | 0.80 | Trivial | 0.24 (− 5.34 to 5.82) | 0.93 | Trivial |
Diarrhea | 4.00 (− 1.86 to 9.86) | 0.17 | Trivial | − 4.33 (− 10.57 to 1.91) | 0.17 | Trivial | − 5.01 (− 11.55 to 1.54) | 0.13 | Small deterioration | − 2.62 (− 9.43 to 4.20) | 0.44 | Trivial |
Financial difficulties | 2.80 (− 0.97 to 6.58) | 0.14 | Trivial | 0.27 (− 3.74 to 4.29) | 0.89 | Trivial | 0.82 (− 3.38 to 5.03) | 0.70 | Trivial | 0.92 (− 3.46 to 5.30) | 0.67 | Trivial |
HADS | ||||||||||||
Anxiety | 0.02 (− 0.68 to 0.73) | 0.95 | No clinical change | − 0.08 (− 0.82 to 0.66) | 0.83 | No clinical change | − 0.76 (− 1.54 to 0.02) | 0.05 | No clinical change | 0.15 (− 0.66 to 0.96) | 0.72 | No clinical change |
Depression | − 0.27 (− 0.93 to 0.39) | 0.41 | No clinical change | − 0.55 (− 1.25 to 0.15) | 0.12 | No clinical change | − 0.65 (− 1.38 to 0.09) | 0.08 | No clinical change | − 0.56 (− 1.32 to 0.21) | 0.15 | No clinical change |