Table 3.
Changes in patient distress due to breathlessness (primary outcome), mastery, anxiety and depression, by trial arm, for patients with non-malignant conditions
| t1a | t2 | t3 | t4 | t5 | Difference in mean t3 adjusted for baseline (I minus C) | With 95 % confidence interval | p-value | |
|---|---|---|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||||
| Control arm (waiting list) | Baseline | Control | Completed control | Midway intervention | Completed intervention | |||
| Intervention arm (fast-track) | Baseline | Midway intervention | Completed intervention | Post-intervention | Post-intervention | |||
| Primary outcome: NRS distress due to breathlessness (0-10)b | ||||||||
| Control arm (waiting list) | 5.61 (3.23) | 5.03 (2.84) | 4.05 (2.57) | 3.73 (2.85) | 3.36 (2.63) | -0.24 | (-1.30,0.82) | p = 0.65 |
| Intervention arm (fast-track) | 6.24 (2.53) | 4.66 (2.85) | 4.02 (2.49) | n/a | 4.25 (2.92) | |||
| Key secondary outcomes: | ||||||||
| CRQc mastery (1-7) | ||||||||
| Control arm (waiting list) | 4.13 (1.25) | 4.03 (1.25) | 4.24 (1.17) | 4.42 (1.30) | 4.74 (1.09) | 0.43 | (-0.02,0.89) | p = 0.06 |
| Intervention arm (fast-track) | 3.85 (1.33) | 4.44 (1.29) | 4.49 (1.35) | n/a | 4.72 (1.11) | |||
| HADSb anxiety (0-21) | ||||||||
| Control arm (waiting list) | 8.32 (4.30) | 9.05 (4.47) | 8.61 (4.25) | 8.00 (4.83) | 7.56 (4.16) | -0.76 | (-1.95,0.44) | p = 0.21 |
| Intervention arm (fast-track) | 7.80 (3.87) | 7.77 (3.49) | 7.45 (3.97) | n/a | 7.57 (3.82) | |||
| HADSb depression (0-21) | ||||||||
| Control arm (waiting list) | 7.71 (3.81) | 7.97 (4.11) | 7.71 (3.83) | 7.86 (4.67) | 7.47 (4.16) | -0.61 | (-1.76,0.54) | p = 0.29 |
| Intervention arm (fast-track) | 6.73 (3.32) | 6.62 (3.65) | 6.28 (3.97) | n/a | 6.80 (4.21) | |||
| Number of respondents | 77-79 | 75-80 | 77-79 | 35-37 | 69-72 | |||
aFor those with a t3 score
bHigh score is worse
cHigh score is better