Table 3.
Mean values (CI) for EORTC QLQ-C30 scores before treatment (baseline) and follow-up and p-values and effect sizes for changes at follow-up compared to baseline
| Base, n = 100 | 1 mo, n = 95 | 2 mo, n = 86 | 3 mo, n = 81 | 6 mo, n = 75 | 12 mo, n = 71 | |
| EORTC QLQ-C30 | ||||||
| Functional scales* | ||||||
| Physical | 85.1 (81.5–88.7) | 81.7 (78.1–85.3) | 81.4 (77.4–85.4) | 84.2 (80.5–87.9) | 85.6 (81.7–89.5) | 88.5 (85.2–91.9) |
| p†/ES‡ | .006/0.32 | .001/0.35 | .038/0.25 | ns/0.18 | ns/0.04 | |
| Role | 77.8 (71.8–83.8) | 65.4 § (58.7–72.2) | 74.1 (67.3–81.0) | 80.7 (74.7–86.6) | 85.4 (79.7–91.0) | 89.2§ 1 (84.5–93.9) |
| p†/ES‡ | 0.000/0.41 | 0.011/0.25 | ns/0.08 | ns/0.06 | ns/0.19 | |
| Social | 86.9 (82.6–91.2) | 80.5 (75.7–85.4) | 83.5 (78.3–88.8) | 87.2 (82.7–91.8) | 88.0 (82.5–93.5) | 90.1 (85.5–94.8) |
| p†/ES‡ | .005/0.26 | ns/0.16 | ns/0.09 | ns/0.07 | ns/0.07 | |
| Emotional | 74.4 (69.7–79.1) | 76.5 (71.9–81.1) | 81.7 (77.7–85.6) | 84.6§ (80.6–88.6) | 83.4 (78.0–88.8) | 89.5§ (85.7–93.2) |
| p†/ES‡ | ns/0.09 | .042/0.26 | .002/0.37 | .009/0.33 | .000/0.61 | |
| Cognitive | 83.5 (79.5–87.5) | 84.0 (80.3–87.7) | 87.8 (84.3–91.3) | 88.1 (84.4–91.7) | 87.6 (83.7–91.5) | 88.3 (84.8–91.7) |
| p†/ES‡ | ns/0.02 | ns/0.15 | ns/0.16 | ns/0.12 | ns/0.19 | |
| Global QLQ | 68.4 (64.1–72.6) | 63.5 (59.1–67.9) | 69.2 (64.7–73.7) | 72.7 (68.4–77.1) | 75.1 (69.9–80.3) | 77.9 (73.0–82.9) |
| p†/ES‡ | .015/0.24 | ns/0.06 | ns/0.08 | ns/0.13 | .007/0.31 | |
| Symptom scales* | ||||||
| Pain | 17.7 (12.7–22.7) | 35.4§ (29.8–41.1) | 23.5 (18.0–28.9) | 17.7 (12.7–22.7) | 14.9 (9.2–20.6) | 8.7 (4.7–12.7) |
| p†/ES‡ | .000/0.67 | .002/0.35 | ns/0.13 | ns/0.04 | ns/0.04 | |
| Fatigue | 25.1 (20.6–29.7) | 39.3§ (34.1–44.5) | 34.6 (29.1–40.2) | 30.3 (25.3–35.3) | 21.2 (16.3–26.1) | 18.2 (13.6–22.7) |
| p†/ES‡ | .000/0.63 | .000/0.52 | .000/0.41 | ns/0.00 | ns/0.16 | |
| Nausea/vomiting | 5.2 (2.9–7.4) | 14.2 (9.7–18.8) | 12.0 (8.0–16.0) | 7.0 (3.2–10.8) | 2.7 (1.0–4.3) | 1.4 (0.3–2.5) |
| p†/ES‡ | .000/0.40 | .000/0.42 | ns/0.19 | ns/0.05 | ns/0.19 | |
*Min-max: 0–100
§ Indicates clinical significant change measured from baseline, i.e. a change of > 10 points
† p-value significant at ≤ 0.05, ns = not significant.
‡ Effect size (ES) of change was calculated as mean change from baseline, divided by the standard deviation of change. Criteria: trivial 0 to < 0.20; small 0.20 to < 0.50; moderate 0.50 to < 0.80; and large ≥ 0.80