Table A3.
Sensitivity analyses of differences between intervention and control group excluding participants with cancer relapse between baseline and 3-month follow up.
| Changes from Baseline to 3-Month Follow-Up | |||||
|---|---|---|---|---|---|
| Intervention Group | Control Group | Difference between Groups a p-Value | Effect SizeCohen’s d [95% Confidence Interval] | Effect Size r | |
| Primary outcome | |||||
| Body weight (%) (29/29) b | 0.45 ± 1.66 | 0.60 ± 2.93 | 0.808 | −0.06 [−0.58–0.45] | |
| Secondary outcomes | |||||
| Physical measurements and tests | |||||
| Body mass index (kg/m2) (29/29) b | 0.45 ± 1.66 | 0.60 ± 2.93 | 0.808 | −0.06 [−0.58, 0.45] | |
| Maximal mouth opening (mm) (29/28) b | 0.6 ± 1.6 | −0.2 ± 2.1 | 0.116 | 0.42 [−0.10, 0.95] | |
| Maximal hand grip strength (kg) (29/29) b | 1.34 ± 0.70 | −0.62 ± 0.62 | 0.038 | 0.55 [0.03, 1.08] | |
| 30-s chair stand test (number of repetitions) (28/28) b |
0.5 ± 2.3 | 2.3 ± 3.2 | 0.017 | −0.66 [−1.20, −0.12] | |
| 6-min walk test (m) (28/27) b | 34.6 ± 43.4 | 7.3 ± 58.5 | 0.055 | 0.52 [−0.10, 1.07] | |
| EQ-5D-5L | |||||
| VAS (31/31) b | 2.0 (−1.0; 10.0) | 4.0 (−6.0; 7.0) | 0.612 | 0.06 | |
| Summary index score (31/31) b | 0.0 (−0.002; 0.044) | 0.0 (−0.042; 0.035) | 0.357 | 0.12 | |
| EORTC QLQ-C30 | |||||
| Global health status/QOL (32/31) b | 0.0 (0; 16.7) | 0.0 (0; 16.7) | 0.864 | −0.02 | |
| Functional scales | |||||
| Physical functioning (32/31) b | 0.0 (0; 6.7) | 0.0 (−6.7; 0) | 0.056 | 0.24 | |
| Role functioning (32/31) b | 0.0 (0; 16.7) | 0.0 (−16.7; 0) | 0.018 | 0.30 | |
| Emotional functioning (32/31) b | 0.0 (0; 4.2) | 0.0 (0; 8.3) | 0.416 | −0.10 | |
| Cognitive functioning 32/31) b | 0.0 (0; 16.7) | 0.0 (0; 0) | 0.101 | 0.21 | |
| Social functioning (32/31) b | 0.0 (0; 16.7) | 0.0 (0; 0) | 0.201 | 0.16 | |
| Symptom scales/items | |||||
| Fatigue (32/31) b | 0.0 (−11.1; 0) | 0.0 (0; 11.1) | 0.029 | −0.27 | |
| Nausea and vomiting (32/31) b | 0.0 (0; 0) | 0.0 (−16.7; 0) | 0.719 | 0.05 | |
| Pain (32/31) b | 0.0 (−16.7; 0) | 0.0 (0; 16.7) | 0.040 | −0.26 | |
| Dyspnoea (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.770 | −0.04 | |
| Insomnia (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.857 | 0.02 | |
| Appetite loss (32/31) b | 0.0 (−33.3; 0) | 0.0 (0; 0) | 1.000 | 0.00 | |
| Constipation (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.976 | 0.003 | |
| Diarrhoea (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.763 | 0.04 | |
| Financial difficulties (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.809 | 0.03 | |
| EORTC QLQ-H&N35 | |||||
| Symptom scales/items | |||||
| Pain (32/31) b | 0.0 (−8.3; 0) | 0.0 (−8.3; 8.3) | 0.511 | −0.08 | |
| Swallowing (32/31) b | −8.3 (−12.5; 0) | −8.3 (−8.3; 0) | 0.978 | 0.003 | |
| Senses problems (32/31) b | 0.0 (−16.7; 0) | 0.0 (−16.7; 0) | 0.358 | 0.12 | |
| Speech problems (32/31) b | 0.0 (−11.1; 0) | 0.0 (0; 0) | 0.277 | −0.14 | |
| Trouble with social eating (32/31) b | 0.0 (−16.7; 0) | 0.0 (−8.3; 0) | 0.322 | −0.12 | |
| Trouble with social contact (32/31) b | 0.0 (−6.7; 0) | 0.0 (−6.7; 0) | 0.918 | −0.01 | |
| Less sexuality (30/30) b | 0.0 (−16.7; 16.7) | 0.0 (−33.3; 0) | 0.470 | 0.09 | |
| Teeth (32/31) b | 0.0 (−33.3; 0) | 0.0 (0; 0) | 0.196 | −0.16 | |
| Opening mouth (32/31) b | 0.0 (−33.3; 0) | 0.0 (0; 0) | 0.148 | −0.18 | |
| Dry mouth (32/31) b | 0.0 (−33.3; 0) | 0.0 (0; 0) | 0.190 | −0.17 | |
| Sticky saliva (31/31) b | 0.0 (0; 0) | 0.0 (−33.3; 0) | 0.493 | 0.19 | |
| Coughing (32/31) b | 0.0 (−33.3; 0) | 0.0 (−33.3; 0) | 0.435 | 0.10 | |
| Felt ill (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.032 | 0.27 | |
| Pain killers (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.755 | 0.04 | |
| Nutritional supplements (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.013 | 0.31 | |
| Feeding tube (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.564 | −0.07 | |
| Weight loss (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.444 | −0.10 | |
| Weight gain (32/31) b | 0.0 (0; 0) | 0.0 (0; 0) | 0.226 | 0.15 | |
| HADS | |||||
| Anxiety (31/31) b | −1.0 (−2.0; 1.0) | 0.0 (−1.0; 1.0) | 0.062 | −0.24 | |
| Depression (31/31) b | 0.0 (−1.0; 0) | 0.0 (−2.0; 1.0) | 0.925 | 0.01 | |
EORTC: European Organization for Research and Treatment of Cancer, HADS: Hospital anxiety and depression scale. Data are presented as means ± standard deviations or 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 within groups are tested with a two-sided paired t-test for primary outcome and other physical tests and measurements, while the Wilcoxon signed-rank test was used for EQ-5D-5L, EORTC, and HADS data. b n included in analyses in (intervention/control) groups.