Table 2.
Mean values, standard deviations (SD), mean difference (MD), 99% confidence intervals (CI) at the end of treatment and at the first follow-up visit according to treatment group
| Pre-selected scales | At end of treatment (4 months) | At first follow-up visit (8 months) | Test for interaction‡ | ||||||
|---|---|---|---|---|---|---|---|---|---|
| EORTC subscales | Experimental group Mean (SD) |
Standard group Mean (SD) |
MD# (99% CI) | P | Experimental group Mean (SD) |
Standard group Mean (SD) |
MD# (99% CI) | P | P |
| EORTC QLQ-C30 | |||||||||
| Global health status | 41.0 (21.4) | 55.2 (21.0) | − 14 (− 18 to − 10)M | < 0.001 | 66.6 (18.8) | 67.6 (19.7) | − 1 (− 5 to 3) | 0.570 | < 0.001 |
| Physical functioning | 64.9 (21.5) | 73.6 (18.9) | − 9 (− 12 to − 6)S | < 0.001 | 82.2 (16.6) | 84.4 (14.6) | − 3 (− 6 to 1) | 0.031 | < 0.001 |
| Role functioning | 33.2 (29.2) | 47.8 (30.9) | − 15 (− 20 to − 9)M | < 0.001 | 64.3 (29.6) | 69.1 (28.3) | − 5 (− 10 to 1)S | 0.028 | < 0.001 |
| Emotional functioning | 68.3 (22.3) | 69.9 (22.6) | − 2 (− 6 to 3) | 0.307 | 73.3 (21.4) | 72.0 (23.6) | 2 (− 3 to 6) | 0.353 | 0.055 |
| Social functioning | 50.1 (27.9) | 59.9 (25.4) | − 10 (− 15 to − 5)M | < 0.001 | 74.4 (25.0) | 77.4 (23.5) | − 3 (− 7 to 2) | 0.160 | < 0.001 |
| Fatigue | 61.3 (25.6) | 49.1 (25.3) | 12 (8 to 17)M | < 0.001 | 34.4 (23.1) | 32.0 (22.7) | 3 (− 2 to 7) | 0.157 | < 0.001 |
| EORTC QLQ− BR23 | |||||||||
| Body image | 56.7 (28.8) | 56.7 (29.5) | 0 (− 5 to 5) | 0.896 | 70.1 (25.5) | 68.9 (28.0) | 2 (− 3 to 7) | 0.414 | 0.884 |
| Sexual functioning | 10.2 (15.9) | 15.1 (18.7) | − 5 (− 9 to − 1)S | 0.001 | 20.9 (21.3) | 24.3 (21.1) | − 3 (− 7 to 1) | 0.045 | 0.057 |
| Systemic therapy | 52.2 (18.2) | 40.7 (19.2) | 12 (9 to 14)M | < 0.001 | 19.9 (14.1) | 17.2 (13.9) | 3 (0 to 5) | 0.024 | < 0.001 |
| Breast symptoms | 13.3 (14.9) | 13.5 (15.0) | 0 (− 4 to 3) | 0.785 | 22.7 (19.7) | 21.8 (19.1) | 0 (− 3 to 4) | 0.762 | 0.904 |
| Arm symptoms | 12.0 (16.4) | 13.8 (16.5) | − 2 (− 5 to 2) | 0.194 | 24.2 (21.2) | 22.5 (19.8) | 2 (− 2 to 6) | 0.182 | 0.077 |
#Mean difference and 99% confidence intervals estimated using linear mixed effects model with a random intercept and a random slope
‡A significant treatment × time interaction indicates different effects of treatment over time
S Small clinical difference, M Moderate clinical difference (Osoba 1998)