Table 3.
Coprimary and secondary outcomes by trial arm
| Outcome | Mean (SE) | Adjusted trial arm effect | |||
| RDSI | Control | β | 95% CI | P value* | |
| Breathlessness (Dyspnoea-12) | |||||
| Baseline | 16.71 (0.93) | 15.31 (0.91) | |||
| 4 weeks | 12.86 (1.20) | 14.95 (1.14) | −3.15 | −5.82 to −0.48 | 0.021 |
| 12 weeks | 11.45 (1.31) | 14.35 (1.14) | −4.13 | −7.09 to −1.18 | 0.007 |
| Cough (MCLC) | |||||
| Baseline | 13.69 (0.88) | 13.95 (0.92) | |||
| 4 weeks | 11.10 (1.09) | 15.28 (1.04) | −4.02 | −6.37 to −1.68 | 0.001 |
| 12 weeks | 8.47 (1.29) | 14.04 (1.08) | −5.49 | −8.43 to −2.55 | <0.001 |
| Fatigue (FACIT-F) | |||||
| Baseline | 24.32 (0.99) | 24.07 (1.07) | |||
| 4 weeks | 27.42 (1.69) | 23.90 (1.36) | 3.47 | −0.38 to 7.31 | 0.077 |
| 12 weeks | 28.62 (2.09) | 23.72 (1.44) | 4.91 | 0.24 to 9.57 | 0.039 |
| NRS coping with symptoms (breathlessness) | |||||
| Baseline | 6.29 (0.23) | 6.09 (0.20) | |||
| 4 weeks | 6.67 (0.34) | 5.77 (0.30) | 0.81 | −0.03 to 1.65 | 0.424 |
| 12 weeks | 6.97 (0.39) | 5.85 (0.35) | 1.07 | 0.13 to 2.01 | 0.026 |
| NRS coping with symptoms (cough) | |||||
| Baseline | 6.43 (0.26) | 6.36 (0.25) | |||
| 4 weeks | 7.12 (0.41) | 6.29 (0.34) | 0.78 | −0.21 to 1.77 | 0.120 |
| 12 weeks | 7.41 (0.45) | 6.28 (0.39) | 1.18 | 0.07 to 2.30 | 0.037 |
| NRS coping with symptoms (fatigue) | |||||
| Baseline | 4.97 (0.24) | 5.29 (0.24) | |||
| 4 weeks | 5.96 (0.41) | 5.17 (0.29) | 0.96 | 0.03 to 1.89 | 0.042 |
| 12 weeks | 5.78 (0.48) | 5.25 (0.37) | 0.62 | −0.52 to 1.76 | 0.284 |
| HADS Questionnaire: Anxiety | |||||
| Baseline | 7.33 (0.42) | 6.81 (0.43) | |||
| 4 weeks | 6.81 (0.60) | 7.73 (0.46) | −1.32 | −2.53 to −0.12 | 0.031 |
| 12 weeks | 6.40 (0.57) | 7.19 (0.52) | −1.20 | −2.45 to 0.05 | 0.061 |
| HADS Questionnaire: Depression | |||||
| Baseline | 6.91 (0.34) | 7.16 (0.36) | |||
| 4 weeks | 7.13 (0.51) | 7.69 (0.44) | −0.40 | −1.54 to 0.73 | 0.482 |
| 12 weeks | 6.90 (0.73) | 7.63 (0.53) | −0.60 | −2.28 to 1.09 | 0.482 |
Unadjusted means and standard errors for coprimary and secondary outcomes by trial arm and time point derived from 100 imputation sets. Adjusted trial arm effects from ANCOVA models are also provided at 4 and 12 weeks, respectively.
*Reference two-tail significance levels are (2*0.05/3) = 0.033 for the 3 coprimary outcomes (Breathlessness, Cough and Fatigue) and 0.05 for secondary outcomes.
ANCOVA, analysis of covariance; FACIT-F, Functional Assessment of Chronic Illness-Fatigue; HADS, Hospital Anxiety and Depression Scale; MCLC, Manchester Cough in Lung Cancer; NRS, Numerical Rating Scale; RDSI, respiratory distress symptom intervention.