Table 4.
Mean scores (based on GEE analyses) of the outcome measures for the study participants in the two treatment groups over time.
| Outcome | Group | Baseline | Week 4 | Week 8 | Week 12 | p-value |
|---|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |||
| Fact-Br Total | 1:1 | 92.8 (19.1) | 90.6 (15.9) | 90.9 (15.7) | 91.2 (12.6) | |
| 4:1 | 93.6 (13.3) | 91.3 (14.2) | 85.7 (15) | 87.9 (17.1) | 0.999 | |
| Total | 93.2 (16.3) | 90.9 (14.9) | 88.3 (15.5) | 89.5 (15) | ||
| Physical | 1:1 | 6.4 (5.2) | 5 (4.9) | 6.4 (6.2) | 6.4 (6.2) | |
| 4:1 | 8.5 (5.5) | 8.4 (7.2) | 7 (5.1) | 6.5 (4) | 0.045 | |
| Total | 7.4 (5.5) | 6.7 (6.4) | 6.7 (5.6) | 6.5 (5.2) | ||
| Social | 1:1 | 21.3 (6.2) | 22.5 (3.7) | 22.3 (4.3) | 22.5 (3.7) | |
| 4:1 | 21.6 (5.1) | 20.3 (4.8) | 20 (4.8) | 20.4 (5.3) | 0.420 | |
| Total | 21.5 (5.6) | 21.4 (4.5) | 21.1 (4.6) | 21.4 (4.7) | ||
| Emotional | 1:1 | 9.8 (5) | 8.05 (4.4) | 7.8 (5) | 8.4 (6.7) | |
| 4:1 | 9.3 (4.5) | 8.2 (4.6) | 7.1 (3.7) | 7.7 (3.8) | 0.713 | |
| Total | 9.6 (4.7) | 8.1 (4.5) | 7.5 (4.4) | 8 (4) | ||
| Functional | 1:1 | 16.9 (7.5) | 17.5 (6.3) | 17.1 (5.7) | 17.8 (6.8) | |
| 4:1 | 14.5 (6.9) | 14.4 (5.9) | 14.6 (7.1) | 15.7 (6.3) | 0.061 | |
| Total | 15.7 (7.3) | 15.9 (6.3) | 15.8 (6.7) | 16.7 (6.6) | ||
| Brain | 1:1 | 38.3 (9.6) | 37.5 (13.8) | 37.3 (9.5) | 36.1 (8.8) | |
| 4:1 | 39.8 (7.8) | 39.3 (8.6) | 36.5 (7.9) | 37.5 (10.7) | 0.333 | |
| Total | 39.1 (8.7) | 38.4 (11.4) | 36.9 (8.7) | 36.8 (9.7) | ||
| Pain | 1:1 | 0.58 (0.92) | 0.35 (07) | 0.6 (0.1) | 0.6 (.87) | |
| 4:1 | 0.76 (1.1) | 0.77 (0.9) | 0.76 (1.1) | 0.89 (1.2) | 0.234 | |
| Total | 0.67(1) | 0.57 (0.86) | 0.68 (1.1) | 0.75 (1.1) | ||
| Sleep | 1:1 | 2.6 (1.4) | 3.4 (0.9) | 3.6 (0.7) | 3.4 (0.9) | |
| 4:1 | 2.1 (1.4) | 2.7 (1.2) | 3.1 (0.87) | 3.2 (0.8) | 0.012 | |
| Total | 2.3 (1.4) | 3 (1.1) | 3.3 (0.82) | 3.3 (0.87) | ||
| Nausea | 1:1 | 0.43 (0.74) | 0.35 90.74) | 0.56 (0.1) | 0.78 (1.1) | |
| 4:1 | 0.54 (0.94) | 0.56 (0.1) | 0.74 (0.1) | 0.55 (0.73) | 0.068 | |
| Total | 0.5 (0.84) | 0.46 (0.85) | 0.67 (0.1) | 0.67 (0.95) | ||
| Anxiety | 1:1 | 1.2 (1.2) | 0.82 (0.91) | 0.94 (1.2) | 0.78 (0.9) | |
| 4:1 | 1.3 (1.2) | 0.8 (0.9) | 0.8 (0.93) | 0.75 (0.9 | 0.816 | |
| Total | 1.3 (1.3) | 0.81 (0.9) | 0.86 (1.1) | 0.77 (0.98) | ||
| Seizures | 1:1 | 0.51 (1.1) | 0.41 (0.9) | 0.5 (1.1) | 0.25 (0.8) | |
| 4:1 | 0.67 (1.2) | 0.42 (1) | 0.2 (0.71) | 0.34 (0.85) | 0.701 | |
| Total | 0.6 (1.1) | 0.42 (0.96) | 0.34 (0.92) | 0.29 (0.84) | ||
| Enjoyment of life | 1:1 | 2.7 (1.1) | 2.7 (1.2) | 2.9 (1) | 2.7 (1.1) | |
| 4:1 | 2.6 (1.3) | 2.5 (1) | 2.3 (1.1) | 2.6 (0.98) | 0.222 | |
| Total | 2.6 (1.2) | 2.6 (1.1) | 2.6 (1.1) | 2.7 (1) | ||
| Content with QoL | 1:1 | 2.4 (1.4) | 2.5 (1.2) | 2.4 (1.1) | 2.5 (1.3) | |
| 4:1 | 1.9 (1.4) | 1.8 (1.3) | 2.1 (1.4) | 1.9 (1.3) | 0.027 | |
| Total | 2.2 (1.4) | 2.1 (1.3) | 2.2 (1.3) | 2.2 (1.3) |