Background
Methods
Outcome and measurements
Statistical analyses
Results
No use of psychosocial support services (n = 279)(n,%) | Use of psychosocial support services (n = 70)(n,%) |
p-value
| |
---|---|---|---|
Age, years | *0.003 | ||
Mean age (SD) | 66.92 (9.7) | 62.74 (11.41) | |
Gender | 0.415 | ||
Male | 182 (65.2) | 42 (60.0) | |
Female | 97 (34.8) | 28 (40.0) | |
Treatment arm in TES trial | 0.610 | ||
Intervention | 149 (53.4) | 35 (50) | |
Control | 130 (46.6) | 35 (50) | |
ECOG PSa | 0.714 | ||
0 | 67 (24.0) | 15 (21.4) | |
1 | 87 (31.2) | 18 (25.7) | |
2 | 8 (2.9) | 3 (4.3) | |
Missing | 117 (41.9) | 34 (48.6) | |
Primary tumor location | 0.695 | ||
Right-sided | 84 (30.1) | 23 (32.9) | |
Left-sided | 192 (68.8) | 47 (67.1) | |
Missing | 3 (1.1) | – | |
Chemotherapy regimen | 0.875 | ||
Capecitabine | 59 (21.1) | 13 (18.6) | |
CAPOX | 190 (68.1) | 50 (71.4) | |
FOLFOX/Other | 27 (9.7) | 7 (10.0) | |
Missing | 3 (1.1) | – | |
Number of comorbidities | 0.980 | ||
Mean (SD) | 2.33 (1.78) | 2.33 (2.00) | |
Marital status | 0.369 | ||
Married/domestic partnership | 207 (74.2) | 49 (70.0) | |
Unmarried/divorced/widowed | 68 (24.4) | 21 (30.0) | |
Missing | 4 (1.4) | – | |
Number of persons in household | 0.615 | ||
1 | 49 (17.6) | 13 (18.6) | |
2 | 177 (63.4) | 42 (60.0) | |
3 | 23 (8.2) | 4 (5.7) | |
> 3 | 26 (9.3) | 11 (15.7) | |
Missing | 4 (1.4) | – | |
Educationb | *0.041 | ||
Low | 17 (6.1) | 2 (2.9) | |
Middle | 184 (65.9) | 39 (55.7) | |
High | 72 (25.8) | 29 (41.4) | |
Missing | 6 (2.2) | 0 (0) | |
Currently working | 0.949 | ||
Yes | 65 (23.3) | 16 (22.9) | |
No/retired | 210 (75.3) | 54 (77.1) | |
Missing | 4 (1.4) | – | |
Time from diagnosis primary tumor until start study | 0.848 | ||
< 1.5 months | 94 (33.7) | 22 (31.4) | |
1.5–10 months | 89 (31.9) | 25 (35.7) | |
> 10 months | 93 (33.3) | 23 (32.9) | |
Missing | 3 (1.1) | – | |
Time from diagnosis metastatic disease until start study | 0.666 | ||
< 1.0 months | 95 (34.1) | 27 (38.6) | |
1.0–2.5 months | 87 (31.2) | 23 (32.9) | |
> 2.5 months | 94 (33.7) | 20 (28.6) | |
Missing | 3 (1.1) | – | |
Prior cancer related treatment | |||
No | 85 (30.5) | 23 (32.9) | 0.699 |
Yes | 194 (69.5 | 47 (67.1) | |
Prior treatment metastases | |||
No | 214 (76.7) | 56 (80.0) | 0.657 |
Yes | 62 (22.2) | 14 (20.0) | |
Missing | 3 (1.1) | – | |
Number of organs with metastases | 0.599 | ||
Median | 2 | 2 | |
Total number of metastases | |||
Median | 11.5 | 13.0 | 0.877 |
Participation in other trials | 0.718 | ||
No | 170 (60.9) | 41 (58.6) | |
Yes | 109 (39.1) | 29 (41.4) | |
HADS | |||
Total score | 9.10 (6.30) | 11.17 (7.47) | *0.020 |
Distress on HADS No | 208 (74.6) | 44 (62.9) | *0.033 |
Yes | 67 (24.0) | 26 (37.1) | |
Missing | 4 (1.4) | – | |
DT/PL | |||
DT score | 4.33 (2.68) | 4.75 (2.40) | *0.242 |
Total of physical problems | 5.78 (6.29) | 7.37 (4.61) | *0.020 |
Total of emotional problems | 1.95 (2.11) | 2.74 (2.57) | *0.009 |
Need to talk to professional No | 257 (92.1) | 58 (82.9) | *0.023 |
Yes | 22 (7.9) | 12 (17.1) | |
Quality of life (QLQ-C30) | |||
Physical functioning | 74.84 (20.30) | 72.76 (21.88) | 0.451 |
Role functioning | 65.69 (30.70) | 58.81 (30.13) | *0.010 |
Emotional functioning | 78.25 (18.12) | 72.86 (21.41) | *0.095 |
Cognitive functioning | 89.44 (14.97) | 86.90 (16.76) | *0.219 |
Social functioning | 78.08 (23.89) | 69.05 (31.38) | *0.010 |
Global QOL | 63.77 (21.73) | 60.00 (21.78) | *0.197 |
Pain score | 16.00 (23.75) | 40.15 (26.57) | *0.174 |
Fatigue score | 25.00 (16.67) | 45.08 (44.44) | *0.009 |
No use of psychosocial support services (n = 279)(n,%) | Use of psychosocial support services (n = 70)(n,%) |
p-value
| |
---|---|---|---|
Progression of disease within first 10 weeks of treatment | *0.089 | ||
No | 242 (86.7) | 66 (94.3) | |
Yes | 37 (13.3) | 4 (5.7) | |
Progression of disease during follow up | 0.289 | ||
No | 93 (33.3) | 28 (40.0) | |
Yes | 186 (66.7) | 42 (60.0) | |
Total number of grade 3–4 AEs during 48 weeks follow up | 1.64 (2.12) | 2.06 (2.65) | *0.166 |
Total number of admissions during 48 weeks follow up | 1.79 (1.34) | 2.13 (1.98) | *0.216 |
Predictive factora | Wald | p-value | Odds Ratio | 95% C.I.for EXP(B) | VIF | |
---|---|---|---|---|---|---|
Lower | Upper | |||||
Need to talk to professional | 4.451 | .035 | 2.360 | 1.063 | 5.240 | 1.010 |
Pain score at baseline | 8.053 | .005 | 1.015 | 1.005 | 1.025 | 1.009 |
Age | 8.066 | .005 | .963 | .938 | .988 | 1.022 |
Education | 5.823 | .054 | 1.031 | |||
Middle compared to low | .084 | .772 | 1.255 | .270 | 5.837 | |
High compared to low | 1.340 | .247 | 2.518 | .527 | 12.024 |
Predictive factora | Wald | p-value | Odds Ratio | 95% C.I.for EXP(B) | VIF | |
---|---|---|---|---|---|---|
Lower | Upper | |||||
Need to talk to professional | 4.712 | .030 | 2.429 | 1.090 | 5.412 | 1.010 |
Pain score at baseline | 9.895 | .002 | 1.017 | 1.006 | 1.028 | 1.030 |
Age | 6.938 | .008 | .965 | .940 | .991 | 1.030 |
Education | 6.190 | .045 | 1.033 | |||
Middle compared to low | .128 | .720 | 1.327 | .283 | 6.229 | |
High compared to low | 1.558 | .212 | 2.729 | .564 | 13.204 | |
Progression within first 10 weeks of treatment | 4.136 | .042 | .314 | .103 | .959 | 1.029 |