Introduction
Patients and methods
Design and study participants
Measures
SCNS-SF34
SCNS-HNC
Other PROMs and clinical measures
Data analyses
SCNS-SF34 | SCNS-HNC | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
P&DL | PSY | SEX | PC&S HIS&PSe
| HS&Ie
| Chewing or swallowing | Dry mouth and/or sticky mucus | Problems with weight | To be informed on nutrition | Difficulty speaking | |
HADS | ||||||||||
Anxiety |
.48
a
|
.65
b
|
.34
a
| .51a
|
a
| |||||
Depression | .61a
|
.64
b
|
.33
a
| .57a
|
a
| |||||
EORTC-QLQ-C30 | ||||||||||
Physical functioning | −.50d
| |||||||||
Role functioning | −.63c
| |||||||||
Emotional functioning | −.56c
|
−.64
d
|
−.47
c
|
c
| ||||||
Cognitive functioning |
−.43
c
|
−.47
c
| ||||||||
Social functioning | −.54c
| |||||||||
Global quality of life |
−.55
d
| −.51c
| ||||||||
Fatigue |
.64
b
| .55a
| .52a
| |||||||
Pain | .47b
|
.42
a
| ||||||||
Dyspnoea | .19a
| |||||||||
Sleep/insomnia |
.42
a
| |||||||||
Appetite loss |
.44
a
|
.38
a
| ||||||||
EORTC QLQ-HN35 | ||||||||||
Swallowing |
.62
b
| |||||||||
Dry mouth | .55a
| |||||||||
Sticky saliva | .57a
| |||||||||
Weight loss |
.40
a
| |||||||||
Weight gain | .08a
| |||||||||
Speech |
.61
b
| |||||||||
Sexuality |
.47
a
| |||||||||
SWAL-QOL | ||||||||||
Symptom |
.62
b
| |||||||||
Food selection |
.48
a
| |||||||||
SHI total score |
.64
b
|
Sample size calculation
Results
Study sample
Characteristics | Factor analyses and construct validity (n = 201) | Test–retest reliability (n = 110) | Content validity (study specific report form) (n = 69) |
---|---|---|---|
% | % | % | |
Age | |||
18–60 years | 31.3 | 25.5 | 46.4 |
>60 years | 68.7 | 74.5 | 53.6 |
Sex | |||
Male | 66.7 | 72.7 | 63.8 |
Female | 33.3 | 27.3 | 36.2 |
Living arrangements | |||
Living alone | 24.4 | 30.0 | 14.3a
|
Living with partner | 58.7 | 59.1 | 59.2 |
Living with partner and children | 15.4 | 10.0 | 22.4 |
Other (e.g. with children) | 1.5 | .9 | 4.1 |
Education | |||
Elementary education | 6.5 | 3.6 | 5.8a
|
Lower education | 37.8 | 40.0 | 24.6 |
Secondary education | 26.9 | 25.5 | 23.2 |
Higher education | 28.9 | 30.9 | 17.4 |
Employment status | |||
Employed (paid/unpaid) | 35.8 | 30.9 | 42.9a
|
Unemployed | 12.5 | 11.8 | 16.3 |
Housewife/houseman | 3.5 | 3.6 | 4.1 |
Retired | 48.3 | 53.6 | 36.7 |
Tumour site | |||
Oral cavity | 31.3 | 33.6 | 30.4 |
Pharynx | 36.8 | 35.5 | 36.2 |
Larynx | 19.9 | 20.9 | 17.4 |
Nasal cavity | 6.0 | 4.5 | 8.7 |
Major salivary glands | 6.0 | 5.5 | 7.2 |
Disease stage (UICC) | |||
Stage I | 27.9 | 30.9 | 23.2 |
Stage II | 13.4 | 10.0 | 21.7 |
Stage III | 16.4 | 16.4 | 18.8 |
Stage IV | 36.8 | 34.5 | 34.8 |
Unknown | 5.5 | 8.2 | 1.4 |
Type of treatment | |||
Surgery | 25.4 | 25.5 | 27.5 |
Radiotherapy | 20.4 | 21.8 | 23.2 |
Surgery and chemoradiation | 8.5 | 7.3 | 5.8 |
Surgery and radiation | 22.4 | 22.7 | 23.2 |
Chemoradiation | 23.4 | 22.7 | 20.3 |
Time since last treatment | |||
<1 year | 38.8 | 34.5 | 44.9 |
1–2 year | 29.9 | 31.8 | 26.1 |
>2 year | 31.3 | 33.6 | 29.0 |
Content validity of the SCNS-HNC
Factor analysis and internal consistency
Item | Factor loadings1
| |||||
---|---|---|---|---|---|---|
Lowest score (%) | Highest score (%) | 1 | 2 | 3 | 4 | |
Physical and daily living
|
38.8
|
0
| ||||
1. Pain | 70.9 | 2.5 | .39 |
.54
| ||
2. Lack of energy/tiredness | 51.0 | 4.5 | .33 | .51 |
.60
| |
3. Feelings unwell a lot of the time | 74.6 | 1.0 | .53 |
.67
| ||
4. Work around the home | 58.4 | 3.0 |
.76
| |||
5. Not being able to do the things you used to do | 57.7 | 7.5 | .39 | .39 |
.69
| |
Psychological
|
29.7
|
0
| ||||
6. Anxiety | 68.0 | 2.5 |
.78
| .31 | ||
7. Feeling down or depressed | 67.7 | 1.0 | .32 |
.78
| ||
8. Feelings of sadness | 66.7 | 2.0 |
.81
| |||
9. Fears about the cancer spreading | 51.5 | 8.5 |
.85
| |||
10. Worry that the results of treatment are beyond your control | 59.7 | 3.5 | .34 |
.74
| ||
11. Uncertainty about the future | 50.0 | 5.5 | .33 |
.82
| ||
12. Learning to feel in control of your situation | 58.0 | 1.5 | .35 |
.68
| .41 | |
13. Keeping a positive look | 54.2 | 3.5 | .31 |
.52
| .42 | |
14. Feelings about death and dying | 65.0 | 4.5 |
.79
| |||
17. Concerns about the worries of those close to you | 60.5 | 2.5 | .38 |
.42
| .30 | |
Sexuality
|
69.9
|
.5
| ||||
15. Changes in sexual feelings | 75.3 | 3.0 | .48 |
.74
| ||
16. Changes in your sexual relationships | 77.8 | 2.5 | .36 |
.84
| ||
31. To be given information about sexual relationships | 85.4 | .5 |
.76
| |||
Health system, information and patient support
|
21.1
|
0
| ||||
18. More choice about which cancer specialists you see | 67.5 | 1.5 |
.47
| .41 | ||
20. Reassurance by medical staff that the way you feel is normal | 43.5 | 2.5 |
.62
| .34 | .31 | |
21. Hospital staff attending promptly to your physical needs | 57.5 | 2.0 |
.73
| |||
22. Hospital staff acknowledging, and showing sensitivity to your feelings and emotional needs | 55.0 | 1.5 |
.75
| |||
23. Being given written information about the important aspects of your care | 58.0 | 2.0 |
.75
| |||
24. Being given information (written, diagrams, drawings) about aspects of managing your illness and side effects at home | 61.5 | 4.0 |
.65
| .30 | ||
25. Being given explanations of those tests for which you would like explanations | 46.2 | 2.5 |
.72
| .31 | ||
26. Being adequately informed about the benefits and side effects of treatments before you choose to have them | 47.2 | 4.5 |
.79
| |||
27. Being informed about your test results as soon as feasible | 43.3 | 11.9 |
.74
| .31 | ||
28. Being informed about cancer which is under control or diminishing (that is, remission) | 38.3 | 10.4 |
.77
| .37 | ||
29. Being informed about things you can do to help yourself to get well | 50.2 | 8.5 |
.78
| .30 | ||
30. Having access to professional counselling (e.g. psychologist, social worker, counsellor, nurse specialist) if you, your family or friends need it | 66.7 | 4.5 |
.67
| .35 | ||
32. Being treated like a person not just another case | 53.2 | 9.5 |
.79
| |||
33. Being treated in a hospital or clinic that is as physically pleasant as possible | 44.3 | 6.5 |
.72
| |||
34. Having one member of hospital staff with whom you can talk to about all aspects of your condition, treatment and follow-up | 47.3 | 6.5 |
.78
| |||
19. More choice about which hospital you attend | 68.5 | 2.0 | – | – | – | – |
Eigenvalue | 16.69 | 3.34 | 1.67 | 1.23 | ||
Variance | 50.58 | 10.11 | 5.05 | 3.71 | ||
Cronbach’s α | .95 | .95 | .89 | .79 |
Factor loadingsa
| ||||
---|---|---|---|---|
Item | Lowest score (%) | Highest score (%) | 1 | 2 |
HNC-specific functioning
|
21.3
|
1.0
| ||
1. Problems with chewing and or swallowing | 47.0 | 8.0 |
.84
| |
2. Problems with dry mouth and/or sticky mucus | 36.0 | 10.0 |
.85
| |
3. Problems with weight (underweight or overweight) | 47.0 | 6.5 |
.74
| |
4. To be informed on nutrition | 57.5 | 5.0 |
.78
| |
5. Difficulty speaking | 54.8 | 5.0 |
.77
| |
7. Problems with hearing | 71.5 | 2.5 |
.59
| |
8. Oral hygiene | 56.6 | 4.5 |
.75
| |
9. Problems with mobility of neck or shoulders | 58.8 | 7.0 |
.70
| |
Lifestyle
|
70.9
|
.5
| ||
10. Quit smoking | 81.4 | 5.0 |
.84
| |
11. Quit drinking | 78.5 | .5 |
.85
| |
6. Care of your stoma and/or voice prosthesisb
| 20.0 | 30.0 | – | – |
Eigenvalue | 4.76 | 1.39 | ||
Variance | 47.63 | 13.94 | ||
Cronbach’s α | .89 | .60 |
Construct validity
Characteristics | Number | SCNS domain | |||||||
---|---|---|---|---|---|---|---|---|---|
Physical and daily living (n = 196) | Psychological (n = 195) | Sexuality (n = 196) | Health system, information and patient support (n = 199) | ||||||
Median (range) |
p value | Median (range) |
p value | Median (range) |
p value | Median (range) |
p value | ||
Age | |||||||||
18–60 years | 63 | 7.5 (0–92.5) | 0 (0–75.0) | 13.3 (0–83.3) | |||||
>60 years | 138 | 10.0 (0–85.0) | 0 (0–100.0) | 15.0 (0–91.7) | |||||
Gender | .11 | .67 | .55 | ||||||
Male | 134 | 10.0 (0–95.0) | 10.0 (0–92.5) | 0 (0–100.0) | |||||
Female | 67 | 12.5 (0–95.0) | 10.0 (0–85.0) | 0 (0–66.7) | |||||
Treatment procedure |
.02
|
.01
| .07 | ||||||
Single treatment | 92 | 5.0 (0–95.0) | 5.0 (0–85.0) | 11.7 (0–85.0) | |||||
Multi modality treatment | 109 | 10.0 (0–95.0) | 15.0 (0–92.5) | 18.3 (0–91.7) | |||||
Time since last treatment |
.02
| ||||||||
0–1 year | 78 | 19.2 (0–91.7) | |||||||
1–2 years | 60 | 13.3 (0–81.7) | |||||||
>2 years | 63 | 7.5 (0–76.7) |