Table 2.
All participants | Participants lost | Remaining participants | |||||
---|---|---|---|---|---|---|---|
Variable | Three sessions | Single session | Total | Three | Single | Three | Single |
N | 52 | 104 | 156 | 9 | 23 | 43 | 81 |
Withdrew at baseline | 2 | 2 | 4 | ||||
Age in years: | |||||||
mean (SD [MS] | 68 (11) [0] | 69 (9) [1] | 69 (9) [1] | 67 (8) [0] | 68 (8) [1] | 69 (11) [0] | 70 (9) [0] |
min, max | 38, 87 | 47, 92 | 38, 92 | 53, 77 | 55, 83 | 38, 87 | 47, 92 |
Sex: N (%) [MS] | |||||||
Female | 21 (43) [1] | 39 (39) [2] | 60 (40) [3] | 1 (11) [0] | 6 (29) [2] | 21 (50) [1] | 33 (41) [0] |
Intrathoracic tumour: N (%) | [0 MS] | [2 MS] | [2 MS] | [0 MS] | [2 MS] | [0 MS] | [0 MS] |
Non-small cell | 14 (28) | 21 (21) | 35 (23.3) | 4 (44) | 5 (24) | 11 (26) | 17 (21) |
Small cell | 1 (2) | 4 (4) | 5 (3.3) | 2 (9) | 1 (2) | 2 (2) | |
Lung (histology not stated) | 30 (60) | 63 (63) | 93 (62) | 5(56) | 13 (62) | 26 (60) | 51 (63) |
Mesothelioma | 4 (8) | 8 (8) | 12 (8) | 1 (5) | 4 (9) | 7 (9) | |
Other | 1 (2) | 4 (4) | 5 (3.3) | 1 (2) | 4 (5) | ||
Metastases: N (%) [MS] | |||||||
Yes | 9 (19) [2] | 14 (16) [12] | 23 (17) [14] | 1 (14) [2] | 5 (29) [6] | 8 (19) [1] | 9 (12) [6] |
Preference: N (%) | [0 MS] | [1 MS] | [1 MS] | [0 MS] | [1 MS] | [0 MS] | [0 MS] |
High | 14 (28) | 20 (20) | 34 (22.5) | 1 (11) | 3 (14) | 13 (30) | 17 (21) |
Low | 8 (16) | 26 (26) | 34 (22.5) | 3 (33) | 5 (23) | 6 (14) | 22 (27) |
No preference | 28 (56) | 55 (54) | 83 (55) | 5 (56) | 14 (64) | 24 (56) | 42 (52) |
Smoking: N (%) | [0 MS] | [2 MS] | [2 MS] | [1 MS] | [1 MS] | [0 MS] | [1 MS] |
Never | 6 (12) | 7 (7) | 13 (9) | 6 (14) | 7 (9) | ||
Current | 7 (14) | 16 (16) | 23 (15) | 2 (25) | 3 (14) | 5 (12) | 13 (16) |
Ex-smoker | 37 (74) | 77 (77) | 114 (76) | 6 (75) | 19 (86) | 32 (74) | 60 (75) |
Karnofsky | |||||||
Mean (SD) [MS] | 70.6 (9.0) [3] | 70.6 (9.9) [7] | 70.6 (9.5) [10] | 62.5 (8.9) [1] | 63.8 (13.2) [2] | 71.7 (8.6) [2] | 72.2 (7.9) [5] |
Breathlessness scores NRS: mean (SD) [MS] | |||||||
Worst | 6.7 (2.0) [6] | 6.9 (1.9) [12] | 6.8 (1.9) [18] | 7.6 (1.8) [1] | 7.4 (1.8) [3] | 6.6 (2.0) [6] | 6.7 (1.9) [10] |
Average | 5.4 (1.8) [6] | 5.6 (1.6) [13] | 5.5 (1.7) [19] | 6.0 (1.3) [1] | 6.6 (2.0) [3] | 5.3 (1.9) [6] | 5.3 (1.4) [11] |
Distress | 4.7 (2.8) [7] | 4.6 (3.1) [12] | 4.6 (3.0) [19] | 4.5 (2.3) [1] | 5.7 (3.0) [3] | 4.7 (2.8) [7] | 4.3 (3.1) [10] |
Cope | 6.4 (2.1) [6] | 7.0 (2.1) [12] | 6.8 (2.1) [18] | 6.3 (2.4) [1] | 6.3 (2.1) [3] | 6.5 (2.0) [6] | 7.2 (2.1) [10] |
Care provided | 6.3 (3.4) [9] | 6.5 (3.4) [20] | 6.5 (3.4) [29] | 5.6 (2.8) [2] | 6.0 (3.6) [4] | 6.3 (3.6) [8] | 6.8 (3.3) [17] |
Chronic Respiratory Questionnaire – SAS: mean (SD) [MS] | |||||||
Dyspnoea domain | 4.41 (1.25) [0] | 4.38 (1.31) [1] | 4.39 (1.30) [1] | 3.95 (1.32) [1] | 4.38 (1.43) [1] | 4.50 (1.22) [0] | 4.38 (1.27) [0] |
Fatigue | 3.02 (0.95) [0] | 3.32 (1.11) [2] | 3.22 (1.07) [2] | 2.72 (0.81) [1] | 2.94 (1.14) [2] | 3.06 (0.97) [0] | 3.41 (1.08) [0] |
Emotional function | 4.17 (1.10) [0] | 4.50 (1.28) [2] | 4.39 (1.23) [2] | 3.54 (1.12) [1] | 3.81 (1.38) [2] | 4.26 (1.09) [0] | 4.68 (1.17) [0] |
Mastery | 3.90 (1.19) [0] | 4.48 (1.17) [2] | 4.2 9 (1.20) [2] | 2.94 (0.50) [1] | 3.78 (1.35) [2] | 4.06 (1.19) [0] | 4.66 (1.03) [0] |
Hospital Anxiety and Depression Scale (HADS): mean (SD) [MS] | |||||||
Anxiety | 7.6 (4.3) [0] | 6.1 (4.4) [4] | 6.6 (4.3) [4] | 8.5 (4.8) [1] | 8.4 (5.0) [3] | 7.6 (4.3) [0] | 5.6 (3.7) [1] |
Depression | 6.6 (3.0) [0] | 6.2 (3.9) [2] | 6.3 (3.6) [2] | 8.1 (2.2) [1] | 7.9 (4.9) [2] | 6.4 (3.1) [0] | 5.8 (3.5) [0] |
Big Five Inventory (BFI): [MS] mean (SD) | [0] | [4] | [4] | [1] | [4] | [0] | [1] |
Extraversion | 3.06 (0.75) | 3.30 (0.83) | 3.22 (0.81) | 3.11 (0.94) | 3.00 (0.78) | 3.05 (0.71) | 3.37 (0.82) |
Agreeableness | 4.22 (0.53) | 4.16 (0.64) | 4.18 (0.60) | 3.96 (0.65) | 3.99 (0.91) | 4.26 (0.49) | 4.20 (0.55) |
Conscientiousness | 4.00 (0.64) | 4.11 (0.61) | 4.07 (0.62) | 3.90 (0.60) | 3.94 (0.69) | 4.00 (0.66) | 4.16 (0.59) |
Neuroticism | 2.64 (0.83) | 2.51 (0.88) | 2.55 (0.86) | 3.01 (0.89) | 2.93 (1.08) | 2.60 (0.82) | 2.40 (0.80) |
Openness | 3.32 (0.75) | 3.30 (0.70) | 3.31 (0.71) | 3.09 (0.81) | 3.11 (0.81) | 3.34 (0.75) | 3.34 (0.67) |
Mental Toughness Questionnaire (MTQ48): [MS] mean (SD) | [1] | [4] | [5] | [3] | [5] | [0] | [0] |
Challenge | 3.7 (0.7) | 3.8 (0.7) | 3.78 (0.7) | 3.7 (0.7) | 3.7 (0.8) | 3.7 (0.7) | 3.8 (0.6) |
Commitment | 3.6 (0.7) | 3.8 (0.6) | 3.7 (0.6) | 3.5 (0.7) | 3.5 (0.8) | 3.6 (0.7) | 3.8 (0.6) |
Control emotion | 3.3 (0.6) | 3.3 (0.6) | 3.3 (0.6) | 3.3 (0.4) | 3.1 (0.8) | 3.25 (0.7) | 3.3 (0.6) |
Control life | 3.6 (0.7) | 3.7 (0.7) | 3.7 (0.7) | 3.7 (0.9) | 3.5 (0.8) | 3.59 (0.7) | 3.77 (0.6) |
Confidence abilities | 3.6 (0.6) | 3.7 (0.6) | 3.7 (0.6) | 3.7 (0.5) | 3.5 (0.8) | 3.6 (0.6) | 3.68 (0.6) |
Confidence interpersonal | 3.72 (0.82) | 3.84 (0.75) | 3.80 (0.77) | 4.12 (0.99) | 3.83 (0.66) | 3.67 (0.79) | 3.83 (0.78) |
Pre-randomisation patient stated preference for study allocation: [MS] N (%) | [0] | [1] | [1] | [0] | [1] | [0] | [0] |
Three sessions | 14 (28) | 20 (20) | 34 (22.5) | 1 (11) | 3 (14) | 13 (30) | 17 (21) |
Single session | 8 (16) | 26 (26) | 34 (22.5) | 3 (33) | 5 (23) | 6 (14) | 22 (27) |
No preference | 28 (56) | 55 (54) | 83 (55) | 5 (56) | 14 (64) | 24 (56) | 42 (52) |
**Adjusted for baseline breathlessness intensity, gender, smoking status, and age; Descriptive statistics of the primary and secondary breathlessness outcome measures, P values and unadjusted and adjusted confidence intervals for the difference between the two arms
N = number SAS, Self-administered survey (supported by research nurse); SD, Standard deviation; AUC, Area under the curve. MS = Missing