eTable 2. Findings of per-protocol and intention-to-treat analyses for secondary outcomes at time t1.
Control group | Intervention group | Significance | Effect size | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Breast cancer | Colon cancer | Total | Breast cancer | Colon cancer | Total | Group | Cancer type | Interaction | Group | |
M (SD); n | M (SD); n | M (SD); n | M (SD); n | M (SD); n | M (SD); n | p | p | p | d*5 (95% CI) | |
SDM-Q-9*1 Per-protocol Intention-to-treat*2 |
80.3 (19.6); 48 75.8 (20.3); 141 |
72.5 (23.7); 28 69.3 (21.8); 77 |
77.4 (21.4); 76 73.5 (21.2); 219 |
72.7 (20.6); 18 73.8 (20.8); 112 |
79.4 (23.9); 24 70.9 (22.2); 87 |
76.5 (22.5); 42 72.0 (21.4); 194 |
0.378 0.759 |
0.167 0.182 |
0.138 0.497 |
–0.07 (−0.45 to 0.31) |
CARE* 3Per-protocol Intention-to-treat*2 |
44.8 (5.7); 51 44.3 (5.5); 142 |
42.8 (7.9); 28 43.7 (6.5); 83 |
44.1 (6.6); 79 44.1 (5.9); 222 |
41.9 (7.8); 18 43.3 (6.2); 117 |
45.7 (3.9); 24 44.6 (4.8); 86 |
44.0 (6.1); 42 43.9 (5.7); 204 |
0.253 0.545 |
0.304 0.692 |
0.079*6 0.345 |
–0.03 (−0.41 to 0.34) |
HADS-Anxiety*4 Per-protocol Intention-to-treat*2 |
8.9 (4.5); 48 9.2 (4.2); 143 |
6.4 (3.9); 27 6.7 (4.2); 73 |
8.0 (4.4); 75 8.4 (4.4); 218 |
6.9 (3.0); 18 7.9 (4.2);116 |
7.7 (4.1); 23 7.8 (4.1); 82 |
7.3 (3.7); 41 7.9 (4.2); 201 |
0.090*6 0.054*6 |
0.020*7 0.001*8 |
0.055*6 0.036*7 |
−0.12 (−0.50 to 0.27) |
HADS-Depression*4 Per-protocol Intention-to-treat*2 |
6.3 (4.2); 49 6.5 (4.3); 138 |
6.5 (3.9); 28 6.2 (4.1); 78 |
6.3 (4.1); 77 6.4 (4.3); 216 |
4.1 (2.8); 18 4.8 (4.1); 121 |
7.3 (5.0); 23 7.2 (4.4); 82 |
5.9 (4.4); 41 5.8 (4.3); 202 |
0.063*6 0.094*6 |
0.839 0.940 |
0.076*6 0.038*7 |
−0.14 (−0.52 to 0.24) |
EORTC-QLQ-30 Quality of Life*1 Per-protocol Intention-to-treat*2 |
59.8 (20.4); 46 58.2 (21.1); 139 |
50.9 (27.3); 28 55.2 (24.8); 75 |
56.4 (23.5); 74 56.8 (22.6); 210 |
56.0 (21.5); 18 55.5 (22.9); 118 |
41.0 (26.0); 24 44.3 (21.5); 81 |
47.7 (25.1); 42 50.7 (23.1); 204 |
0.571 0.619 |
0.128 0.733 |
0.513 0.303 |
−0.27 (−0.65 to 0.11) |
OPTION*1 Per-protocol Intention-to-treat*2 |
24.2 (9.9); 70 23.1 (9.6); 145 |
17.1 (5.4); 28 16.8 (8.3); 79 |
22.1 (9.4); 98 21.1 (9.7); 222 |
33.6 (11.7); 20 30.5 (11.3); 116 |
25.5 (9.9); 27 21.7 (10.2); 83 |
29.0 (11.3); 47 26.9 (11.6); 199 |
0.012*7 0.016*7 |
0.072*6 0.084*6 |
0.921 0.681 |
0.56 (0.21 to 0.91) |
Full findings reported in eMethods.
M, mean; SD, standard deviation; n, sample size; CI, confidence interval; SDM-Q-9, Shared Decision Making Questionnaire; CARE, Consultation and Relational Empathy Scale; HADS, Hospital Anxiety and Depression Scale; EORTC-QLQ-30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; OPTION, Observing Patient Involvement Scale
*1Scores range from 0 to 100. 0 is low, 100 high.
*2Intention-to-treat analysis assuming the most likely scenario: missing values for the control group were estimated on the basis of available data from the control group; missing values for physicians in the intervention group who had undergone training were estimated on the basis of available data from the intervention group; missing values for physicians in the intervention group who had not undergone training were estimated on the basis of data from the control group.
*3Scores range from 0 to 50. 0 is low, 50 high.
*4Scores range from 0 to 21. 0 is low, 21 high for anxiety/depression.
*5Cohen’s d was estimated using means and standard deviations of the intention-to-treat analysis and sample size of the per-protocol analysis.
*6 p <0.10; *7 p <0.05; *8 p <0.01