Table 3. Primary and secondary outcome measures (last observation carried forward analysis).
IG | CG | IG | CG | |||||||
n | Mean (SD) | Mean (SD) | b | [95% CI] | p | AAP | AAP | SMD | ICC | |
Quality of life (EORTC QLQ-C30)*1 | ||||||||||
Role functioning | 482 | 57.60 (30.75) | 52.49 (30.98) | 4.49 | [−0.49; 9.47] | 0.077 | 57.28 | 52.79 | 0.15 | 0.00 |
General health | 477 | 58.63 (21.96) | 56.05 (23.11) | 0.73 | [−3.00; 4.47] | 0.700 | 57.69 | 56.95 | 0.03 | 0.01 |
Physical functioning | 483 | 75.20 (19.33) | 70.40 (22.63) | 3.10 | [0.23; 5.96] | 0.034 | 74.30 | 71.20 | 0.15 | 0.00 |
Emotional functioning | 480 | 56.38 (25.29) | 55.34 (26.02) | 0.34 | [−3.71; 4.39] | 0.871 | 56.03 | 55.69 | 0.01 | 0.00 |
Cognitive functioning | 480 | 64.84 (27.37) | 65.94 (27.16) | −0.42 | [−4.08; 4.00] | 0.984 | 65.39 | 65.44 | −0.00 | 0.00 |
Social functioning | 478 | 61.40 (29.29) | 58.33 (31.45) | 2.41 | [−2.40; 7.22] | 0.326 | 61.06 | 58.65 | 0.08 | 0.00 |
Pain | 481 | 35.31 (29.39) | 41.30 (32.38) | −4.63 | [−9.47; 0.22] | 0.061 | 36.03 | 40.65 | −0.15 | 0.00 |
Fatigue | 481 | 49.66 (24.03) | 52.58 (26.36) | −2.32 | [−6.32; 1.70] | 0.259 | 49.98 | 52.29 | −0.09 | 0.00 |
Fatigue (EORTC FA13)*1 | ||||||||||
Physical fatigue | 481 | 49.01 (26.20) | 50.76 (26.32) | −1.71 | [−6.08; 2.66] | 0.443 | 48.95 | 50.66 | −0.07 | 0.03 |
Emotional fatigue | 481 | 34.81 (25.94) | 35.96 (27.63) | 0.47 | [−3.74; 4.67] | 0.827 | 35.63 | 35.17 | 0.02 | 0.01 |
Cognitive fatigue | 481 | 22.98 (21.79) | 22.22 (22.70) | 2.18 | [−1.11; 5.47] | 0.195 | 23.73 | 21.55 | 0.10 | 0.00 |
Problems affecting daily life | 476 | 44.20 (30.23) | 44.18 (32.15) | 1.27 | [−3.95; 6.49] | 0.634 | 44.82 | 43.55 | 0.04 | 0.01 |
Social consequences of fatigue | 478 | 23.35 (30.05) | 26.29 (31.54) | 1.30 | [−3.66; 6.26] | 0.607 | 25.58 | 24.28 | 0.04 | 0.00 |
Coping with illness (FKV)*2 | ||||||||||
Active problem-oriented coping | 481 | 2.82 (0.91) | 2.92 (0.90) | −0.11 | [−0.27; 0.05] | 0.165 | 2.81 | 2.93 | −0.12 | 0.01 |
Depressive coping | 481 | 2.01 (0.81) | 2.06 (0.87) | −0.01 | [−0.14; 0.12] | 0.873 | 2.03 | 2.04 | −0.01 | 0.00 |
Distraction and self-encouragement | 481 | 3.09 (0.89) | 3.04 (0.86) | 0.02 | [−0.13; 0.16] | 0.834 | 3.07 | 3.06 | 0.02 | 0.02 |
Work-related outcomes | ||||||||||
Work Ability Score*3 | 479 | 5.34 (2.66) | 5.40 (2.79) | −0.10 | [−0.55; 0.35] | 0.654 | 5.32 | 5.42 | −0.04 | 0.02 |
Disability days during past 3 months | 426 | 13.53 (25.61) | 16.59 (29.05) | −3.02 | [−8.17; 2.13] | 0.250 | 13.53 | 16.55 | −0.11 | 0.03 |
We used mixed-effects models to calculate test statistics, controlled for the values of the initial survey.
We substituted missing data with the last available observed data (last observation carried forward [LOCF]).
AAP, Average adjusted predictions; b, non-standardized regression coefficient; CG, control group; CI, confidence interval; EORTC, European Organization for Research and Treatment of Cancer; FA, fatigue; FKV, Freiburg Questionnaire of Coping with Illness; ICC, intracluster correlation coefficient; IG, intervention group; QLQ, Quality of Life Questionnaire; SD standard deviation; SMD, standardized mean difference
*1 Maximum achievable score = 100; *2 maximum achievable score = 5; *3 maximum achievable score = 10