Table 4.
Changes in health-related quality of life and symptoms of anxiety and depression from baseline to 3-month follow-up in the NUTRI-HAB trial.
| Baseline Values | Changes from Baseline to 3-Month Follow-Up | |||||||
|---|---|---|---|---|---|---|---|---|
| Intervention Group | Control Group | Intervention Group | Control Group | Difference between Groups a p-Value |
Effect Size (r) |
Adjusted Model b | ||
| β | p-Value | |||||||
| EQ-5D-5L | ||||||||
| VAS (32/32) c | 79.0 (52.0; 87.5) | 75.0 (61.1; 85.5) | 1.5 (−1.0; 10.0) | 3.5 (−6.0;6.5) | 0.672 | 0.05 | 2.319 | 0.523 |
| Summary Index Score (32/32) c | 0.783 (0.719; 0.859) | 0.787 (0.740; 0.847) | 0.0 (−0.008; 0.043) | 0.0 (−0.280; 0.034) | 0.440 | 0.10 | 0.012 | 0.548 |
| EORTC QLQ-C30 | ||||||||
| Global health status/QOL (33/32) c | 66.7 (58.3; 83.3) | 66.7 (54.2; 83.3) | 0.0 (0; 16.7) | 0.0 (0; 12.5) | 0.870 | −0.02 | −0.310 | 0.943 |
| Functional scales | ||||||||
| Physical functioning (33/32) c | 86.7 (80.0; 100) | 93.3 (76.7; 100) | 0.0 (0; 6.7) | 0.0 (−6.7; 0) | 0.070 | 0.22 | 4.622 | 0.102 |
| Role functioning (33/32) c | 83.3 (66.7; 100) | 83.3 (66.7; 100) | 0.0 (0; 16.7) | 0.0 (−16.7; 0) | 0.024 | 0.28 | 9.630 | 0.041 |
| Emotional functioning (33/32) c | 83.3 (66.7; 100) | 83.3 (66.7; 95.8) | 0.0 (0; 0) | 0.0 (0; 8.3) | 0.416 | −0.10 | −2.740 | 0.464 |
| Cognitive functioning (33/32) c | 83.3 (50.0; 83.3) | 83.3 (66.7; 91.7) | 0.0 (0; 16.7) * | 0.0 (0; 0) | 0.100 | 0.20 | 5.756 | 0.088 |
| Social functioning (33/32) c | 83.3 (66.7; 100) | 100.0 (75.0; 100) | 0.0 (0; 16.7) | 0.0 (0; 0) | 0.211 | 0.16 | 5.525 | 0.238 |
| Symptom scales/items | ||||||||
| Fatigue (33/32) c | 33.3 (11.1; 44.4) | 27.8 (11.1; 33.3) | 0.0 (−11.1; 0) | 0.0 (0; 11.1) | 0.050 | −0.24 | −8.161 | 0.053 |
| Nausea and vomiting (33/32) c | 0.0 (0; 0) | 0.0 (0; 8.3) | 0.0 (0; 0) | 0.0 (−8.3; 0) | 0.723 | 0.04 | 1.054 | 0.787 |
| Pain (33/32) c | 16.7 (0; 33.3) | 16.7 (0; 33.3) | 0.0 (−16.7; 0) | 0.0 (0; 16.7) | 0.029 | −0.27 | −8.536 | 0.048 |
| Dyspnoea (33/32) c | 0.0 (0; 33.3) | 0.0 (0; 33.3) | 0.0 (0; 0) | 0.0 (0; 0) | 0.978 | −0.003 | 1.284 | 0.750 |
| Insomnia (33/32) c | 33.3 (0; 33.3) | 33.3 (0; 50.0) | 0.0 (0; 0) | 0.0 (0; 0) | 0.856 | 0.02 | 0.663 | 0.907 |
| Appetite loss (33/32) c | 0.0 (0; 33.3) | 0.0 (0; 33.3) | 0.0 (−33.3; 0) | 0.0 (0; 0) | 0.879 | −0.02 | −5.582 | 0.383 |
| Constipation (33/32) c | 0.0 (0; 33.3) | 0.0 (0; 33.3) | 0.0 (0; 0) | 0.0 (0; 0) | 0.785 | 0.03 | 0.222 | 0.965 |
| Diarrhoea (33/32) c | 0.0 (0; 0) | 0.0 (0; 0) | 0.0 (0; 0) | 0.0 (0; 0) | 0.776 | 0.04 | 0.297 | 0.943 |
| Financial difficulties (33/32) c | 0.0 (0; 33.3) | 0.0 (0; 33.3) | 0.0 (0; 0) | 0.0 (0; 0) | 0.807 | 0.03 | 1.425 | 0.766 |
| EORTC QLQ-H&N35 | ||||||||
| Symptom scales/items | ||||||||
| Pain (33/32) c | 25.0 (8.3; 33.3) | 16.7 (8.3; 37.5) | 0.0 (−8.3; 0) | 0.0 (−8.3; 8.3) | 0.507 | −0.08 | −5.046 | 0.316 |
| Swallowing (33/32) c | 16.7 (8.3; 33.3) | 25.0 (12.5; 25.0) | 0.0 (−8.3; 0) * | −8.3 (−12.5; 0) * | 0.760 | 0.04 | −1.409 | 0.691 |
| Senses problems (33/32) c | 33.3 (16.7; 50.0) | 25.0 (8.3; 66.7) | 0.0 (−16.7; 0) | 0.0 (−16.7; 0) * | 0.592 | 0.07 | 3.336 | 0.366 |
| Speech problems (33/32) c | 22.2 (11.1; 33.3) | 11.1 (5.6; 22.2) | 0.0 (−11.1; 0) * | 0.0 (0; 0) | 0.136 | −0.18 | −6.306 | 0.040 |
| Trouble with social eating (33/32) c | 25.0 (0; 33.3) | 16.7 (0; 33.3) | 0.0 (−16.7; 0) * | 0.0 (−8.3; 0) | 0.276 | −0.14 | −6.188 | 0.110 |
| Trouble with social contact (33/32) c | 0.0 (0; 20.0) | 3.3 (0; 16.7) | 0.0 (−6.7; 0) | 0.0 (−6.7; 0) | 0.764 | −0.04 | 0.135 | 0.965 |
| Less sexuality (31/31) c | 33.3 (0; 66.7) | 33.3 (0; 66.7) | 0.0 (−16.7; 16.7) | 0.0 (−33.3; 0) | 0.534 | 0.08 | 0.808 | 0.925 |
| Teeth (33/32) c | 0.0 (0; 66.7) | 16.7 (0; 33.3) | 0.0 (−33.3; 0) * | 0.0 (0; 0) | 0.198 | −0.16 | −8.512 | 0.144 |
| Opening mouth (33/32) c | 0.0 (0; 33.3) | 0.0 (0; 33.3) | 0.0 (−33.3; 0) * | 0.0 (0; 0) | 0.148 | −0.18 | −5.607 | 0.256 |
| Dry mouth (33/32) c | 66.7 (33.3; 100) | 66.7 (33.3; 100) | 0.0 (−33.3; 0) * | 0.0 (0; 0) | 0.202 | −0.16 | −10.064 | 0.102 |
| Sticky saliva (32/32) c | 33.3 (33.3; 66.7) | 50.0 (33.3; 100) | 0.0 (−16.7; 0) | 0.0 (−33.3; 0) | 0.629 | 0.06 | 4.182 | 0.521 |
| Coughing (33/32) c | 33.3 (0; 33.3) | 33.3 (33.3; 33.3) | 0.0 (−33.3; 0) | 0.0 (−33.3; 0) * | 0.300 | 0.13 | 10.130 | 0.149 |
| Felt ill (33/32) c | 0.0 (0; 33.3) | 0.0 (0; 33.3) | 0.0 (0; 0) | 0.0 (0; 0) | 0.020 | 0.29 | 10.395 | 0.020 |
| Pain-killers (33/32) c | 0.0 (0; 100) | 100 (0; 100) | 0.0 (0; 0) | 0.0 (0; 0) | 0.755 | 0.04 | 1.515 | 0.887 |
| Nutritional supplements (33/32) c | 0.0 (0; 0) | 0.0 (0; 100) | 0.0 (0; 0) | 0.0 (0; 0) * | 0.013 | 0.31 | 31.465 | 0.005 |
| Feeding tube (33/32) c | 0.0 (0; 0) | 0.0 (0; 0) | 0.0 (0; 0) | 0.0 (0; 0) | 0.313 | −0.13 | −7.271 | 0.240 |
| Weight loss (33/32) c | 0.0 (0; 0) | 0.0 (0; 0) | 0.0 (0; 0) | 0.0 (0; 0) | 0.443 | −0.10 | −9.273 | 0.462 |
| Weight gain (33/32) c | 0.0 (0; 0) | 0.0 (0; 100) | 0.0 (0; 0) | 0.0 (0; 0) | 0.155 | 0.18 | 16.499 | 0.226 |
| HADS | ||||||||
| Anxiety (32/32) c | 4.5 (2.0; 8.0) | 4.0 (1.0; 8.5) | −1.0 (−2.0; 1.0) | 0.0 (−1.0; 1.0) | 0.094 | −0.21 | −1.230 | 0.061 |
| Depression (32/32) c | 4.0 (1.0; 7.5) | 5.0 (2.0; 8.5) | 0.0 (−1.0; 0.5) | 0.0 (−2.0; 1.0) | 0.789 | 0.03 | −0.228 | 0.694 |
EORTC: European Organization for Research and Treatment of Cancer, HADS: Hospital anxiety and depression Scale. Baseline values and changes within groups are shown as medians and quartiles (Q1; Q3). Significant p-values are highlighted in bold. The EQ-5D-5L VAS ranges from 0–100, and the summary index calculated based on Danish values ranges from −0.624 to 1.0. A higher score indicates better self-rated health. The EORTC QLQ-C30 and QLQ-H&N35 scales range from 0–100. A higher score indicates a higher response level. Thus, a high score for a functional scale or global QOL indicates a high level of functioning/QOL and a high score on a symptom scale indicates a high symptom level. The HADS subscales range from 0–21, and a higher score indicates a higher symptom level. a Differences between groups are tested with the Mann–Whitney U test. b Differences between groups assessed in a multiple linear regression model including gender, time interval (months) posttreatment, and rehabilitation needs assessed by the REHPA scale. c n included in analyses in (intervention/control) groups. * Statistically significant change (p < 0.05) within group from baseline to 3-month follow-up tested with the Wilcoxon signed-rank test. Results are shown in Appendix B, Table A2.