Background
Methods
Study population
Study measures
Statistical analysis
Results
Patient characteristics
Characteristic | Overall sample (n = 153) |
---|---|
Age, years | |
Mean (SD) | 63.4 (9.2) |
Min, max | 37, 83 |
Sex | |
Male | 83 (54.2) |
Ethnicity | |
White/Caucasian | 143 (93.5) |
Asian | 3 (2.0) |
Negroid | 2 (1.3) |
Other | 5 (3.3) |
Educationa | |
Low | 113 (73.9) |
High | 33 (21.6) |
Unknown | 7 (4.6) |
Employment | |
Yes | 40 (26.1) |
No | 112 (73.2) |
Unknown | 1 (0.7) |
Partner status | |
Married/cohabiting | 116 (75.8) |
Unmarried partners/not cohabiting | 6 (3.9) |
Divorced/separated | 14 (9.2) |
Widowed/partner died | 10 (6.5) |
Single | 6 (3.9) |
Unknown | 1 (0.7) |
Cancer stageb | |
Locally advanced (IIIB) | 19 (12.4) |
Metastatic (IV) | 119 (77.8) |
Other | 14 (9.2) |
Unknown | 1 (0.7) |
Type of tumorb | |
Adenocarcinoma | 141 (92.2) |
Large cell carcinoma | 4 (2.6) |
Mesothelioma | 7 (4.6) |
Large cell neuroendocrine carcinoma | 1 (0.7) |
Line of therapy | |
First line | 134 (87.6) |
Second line | 10 (6.5) |
Third line | 1 (0.7) |
Adjuvant | 8 (5.2) |
ECOG performance statusa | |
Grade 0 | 39 (25.5) |
Grade 1 | 99 (64.7) |
Grade 2 | 11 (7.2) |
Grade 3 | 2 (1.3) |
Unknown | 2 (1.3) |
Mean scores, floor and ceiling effects, and skewness
Items/domains | Description |
n
| Mean (SD) | Floor effect (%) | Ceiling effect (%) | Scale pointsa | ||||
---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | ||||||
General facet | ||||||||||
Overall QoL | 150 | 5.9 (1.8) | 4 (2.7) | 3 (2.0) | 3.3 | 14.4 | 24.2 | 44.4 | 12.4 | |
General Health | 21.6 | 35.9 | 26.1 | 13.1 | 2.6 | |||||
Physical Health | ||||||||||
3 | Pain | 153 | 12.9 (3.1) | 1 (0.7) | 1 (0.7) | 28.1 | 28.8 | 19.0 | 20.3 | 3.3 |
4 | Medication | 11.8 | 26.8 | 25.5 | 24.8 | 10.5 | ||||
10 | Energy | 3.9 | 19.6 | 35.9 | 25.5 | 14.4 | ||||
15 | Sleep | 8.5 | 23.5 | 26.1 | 26.1 | 15.0 | ||||
16 | Activities | 7.8 | 34.6 | 24.8 | 26.8 | 5.9 | ||||
17 | Work | 12.4 | 39.2 | 21.6 | 20.3 | 6.5 | ||||
25 | Mobility | 4.6 | 11.8 | 13.1 | 35.3 | 35.3 | ||||
Psychological Health | ||||||||||
5 | Positive feelings | 153 | 14.4 (2.5) | 0 (0.0) | 2 (1.3) |
3.9
|
7.8
| 39.2 | 41.2 | 7.8 |
6 | Spirituality |
2.6
|
5.2
| 32.7 | 43.8 | 15.0 | ||||
7 | Cognitions |
4.6
|
9.8
| 44.4 | 22.2 | 19.0 | ||||
11 | Body image |
0.7
|
4.6
| 28.1 | 26.1 | 39.9 | ||||
18 | Self esteem |
0.7
|
9.8
| 30.7 | 43.8 | 13.7 | ||||
26 | Negative feelings | 14.4 | 32.7 | 43.1 |
9.8
|
0.0
| ||||
Social Relationships | ||||||||||
19 | Personal relations | 153 | 16.2 (2.6) | 0 (0.0) | 20 (13.1) |
0.7
|
0.7
|
6.5
| 40.5 | 50.3 |
20 | Sex | 5.9 | 13.7 | 36.6 | 24.8 | 16.3 | ||||
21 | Social support |
0.7
|
1.3
|
9.2
| 34.0 | 54.9 | ||||
Environment | ||||||||||
8 | Safety & security | 153 | 15.9 (2.3) | 0 (0.0) | 1 (0.7) |
0.7
|
3.9
| 26.8 | 32.0 | 36.6 |
9 | Physical environment |
0.7
|
2.0
| 26.8 | 35.3 | 34.0 | ||||
12 | Finance |
2.0
|
6.5
| 37.3 | 21.6 | 32.0 | ||||
13 | Information |
0.0
|
0.7
| 36.6 | 37.3 | 24.8 | ||||
14 | Leisure | 3.9 | 13.1 | 24.2 | 35.3 | 23.5 | ||||
22 | Home environment |
2.6
|
5.2
| 12.4 | 39.9 | 39.9 | ||||
23 | Health/social care |
1.3
|
2.0
| 15.7 | 49.0 | 32.0 | ||||
24 | Transport |
1.3
|
2.0
|
9.2
| 43.8 | 43.8 |
Confirmatory factor analysis
Multi-trait/multi-item analyses and internal consistency
Items/domains | Description | Physical Health | Psychological Health | Social Relationships | Environment |
---|---|---|---|---|---|
Physical Health | |||||
3R | Pain | .53a | .41 |
.20
|
.35
|
4R | Medication | .40a |
.24
|
.01
|
.21
|
10 | Energy | .57a | .53 |
.13
| .42 |
15 | Sleep | .27a | .32 |
.06
| .27 |
16 | Activities | .72a | .56 |
.17
|
.46
|
17 | Work | .70a |
.54
|
.17
|
.43
|
25 | Mobility | .61a | .47 |
.24
|
.45
|
Psychological Health | |||||
5 | Positive feelings | .52 | .67a |
.33
|
.47
|
6 | Spirituality |
.34
| .53a |
.24
|
.36
|
7 | Cognitions | .44 | .48a |
.20
| .48 |
11 | Body image | .32 | .34a | .30 | .45 |
18 | Self esteem | .60 | .58a |
.38
| .49 |
26R | Negative feelings | .43 | .52a |
.21
| .43 |
Social Relationships | |||||
19 | Personal relations |
.16
| .30 | .43a | .47 |
20 | Sex |
.15
| .31 | .32a | .31 |
21 | Social support |
.16
| .28 | .43a | .42 |
Environment | |||||
8 | Safety & security | .46 | .57 |
.36
| .60a |
9 | Physical environment |
.12
| .35 | .31 | .38a |
12 | Finance | .23 | .29 | .26 | .30a |
13 | Information |
.24
|
.33
|
.36
| .53a |
14 | Leisure | .41 | .34 |
.19
| .46a |
22 | Home environment | .46 | .55 | .41 | .56a |
23 | Health/social care | .36 | .41 | .32 | .41a |
24 | Transport |
.39
| .44 | .43 | .57a |
Construct validity
EORTC QLQ-C30 domains/Items | WHOQOL-BREF domains/items | ||||
---|---|---|---|---|---|
General facet | Physical Health | Psychological Health | Social Relationships | Environment | |
Physical Functioning | 0.43* | 0.73* | 0.37* | 0.04 | 0.26* |
Role Functioning | 0.46* | 0.73* | 0.46* | 0.08 | 0.26* |
Emotional Functioning | 0.49* | 0.51* | 0.61* | 0.19** | 0.43* |
Cognitive Functioning | 0.33* | 0.49* | 0.47* | 0.08 | 0.40* |
Social Functioning | 0.42* | 0.59* | 0.47* | 0.07 | 0.32* |
Global Health Status/QoL | 0.67* | 0.73* | 0.58* | 0.12 | 0.39* |
Fatigue | − 0.39* | − 0.69* | − 0.44* | − 0.06 | −0.33* |
Nausea and vomiting | −0.32* | − 0.29* | − 0.24* | − 0.16 | −0.05 |
Pain | −0.32* | − 0.62* | − 0.28* | − 0.06 | −0.26* |
Dyspnoea | − 0.28* | − 0.30* | − 0.15 | 0.05 | −0.10 |
Insomnia | −0.29* | − 0.49* | − 0.35* | − 0.04 | −0.32* |
Appetite loss | − 0.36* | − 0.38* | − 0.22* | 0.02 | −0.05 |
Constipation | −0.17** | − 0.23* | − 0.18** | − 0.06 | −0.24* |
Diarrhea | 0.00 | −0.08 | − 0.04 | −0.10 | − 0.06 |
Financial problems | −0.03 | − 0.34* | − 0.22* | − 0.11 | −0.36* |
General Facet | Physical Health | Psychological Health | Social Relationships | Environment | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n
| Mean (SD) | P-value (effect size)* |
n
| Mean (SD) | P-value (effect size)* |
n
| Mean (SD) | P-value (effect size)* |
n
| Mean (SD) | P-value (effect size)* |
n
| Mean (SD) | P-value (effect size)* | |
Number of different adverse eventsa | |||||||||||||||
0–5 | 84 | 6.1 (1.7) | 0.10 | 87 | 13.6 (3.1) | < 0.001 (0.08) | 87 | 14.5 (2.5) | 0.47 | 87 | 16.1 (2.7) | 0.37 | 87 | 15.8 (2.2) | 0.81 |
more than 5 | 66 | 5.6 (1.8) | 66 | 11.8 (2.9) | 66 | 14.2 (2.6) | 66 | 16.4 (2.4) | 66 | 15.9 (2.4) | |||||
Number of different adverse events with CTCAE grade 3 or 4a | |||||||||||||||
0 | 112 | 6.0 (1.8) | 0.16 | 115 | 13.1 (3.1) | 0.06 | 115 | 14.4 (2.4) | 0.93 | 115 | 16.1 (2.6) | 0.36 | 115 | 15.8 (2.3) | 0.82 |
1 | 27 | 6.0 (1.8) | 27 | 12.8 (3.0) | 27 | 14.4 (2.8) | 27 | 16.5 (2.6) 17.1 (2.2) | 27 | 16.0 (2.3) | |||||
2 or more | 11 | 4.9 (1.4) | 11 | 10.8 (2.6) | 11 | 14.7 (2.9) | 11 | 16.3 (2.5) | 11 | 16.1 (2.6) | |||||
ECOG performance scoreb | 16.5 (2.3) | ||||||||||||||
0 | 37 | 6.6 (1.5) | < 0.001 (0.08) | 39 | 15.1 (2.3) | < 0.001 (0.23) | 39 | 15.1 (2.2) | 0.04 (0.04) | 39 | 14.7 (3.5) | 0.05 | 39 | 16.1 (1.8) | 0.38 |
1 | 98 | 5.7 (1.8) | 99 | 12.3 (3.0) | 99 | 14.3 (2.6) | 99 | 99 | 15.9 (2.5) | ||||||
2 or more | 13 | 4.8 (1.1) | 13 | 10.2 (2.0) | 13 | 13.1 (2.2) | 13 | 13 | 15.1 (2.3) | ||||||
Global health status/QoL EORTC QLQ-C30 score | |||||||||||||||
0–50 | 67 | 4.9 (1.5) | < 0.001 (0.30) | 69 | 10.8 (2.7) | < 0.001 (0.36) | 69 | 13.1 (2.6) | < 0.001 (0.22) | 69 | 16.0 (2.8) | 0.28 | 69 | 15.1 (2.4) | < 0.001 (0.10) |
more than 50 | 79 | 6.8 (1.4) | 80 | 14.6 (2.3) | 80 | 15.5 (1.9) | 80 | 16.5 (2.3) | 80 | 16.6 (2.0) |
Minimal clinically important differences
Domains | 0.5 SD | 1 SEM |
---|---|---|
General Facet | 0.876 | |
Physical Health | 1.545 | 2.155 |
Psychological Health | 1.259 | 1.914 |
Social Relationships | 1.274 | 2.716 |
Environment | 1.142 | 1.761 |