Introduction
Methods
Study design and patients
Phase 1
Phase 2
Phase 3
Data analyses and criteria for item selection
Results
Phase 1: generation of issues
HL (N = 75) | HG-NHL (N = 66) | LG-NHL (N = 41) | CLL (N = 63) | |
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Country (language) | ||||
Italy (Italian) | 26 (35) | 24 (36) | 17 (41) | 33 (52) |
Netherlands (Dutch) | 30 (40) | 16 (24) | 14 (34) | 23 (37) |
Taiwan (Taiwanese) | 1 (1) | 9 (14) | 3 (7) | 1 (1) |
UK (English) | 18 (24) | 17 (26) | 7 (17) | 6 (10) |
Age (years) | ||||
Mean (SD) | 40 (17) | 55 (17) | 62 (12) | 68 (9) |
Range | 18–78 | 18–86 | 41–82 | 49–85 |
Sex | ||||
Male | 41 (55) | 37 (57) | 19 (48) | 41 (66) |
Female | 33 (45) | 28 (43) | 21 (53) | 21 (34) |
Time since diagnosis (years) | ||||
Mean (SD) | 3.4 (3.6) | 2.3 (3.1) | 5.2 (4.3) | 4.1 (3.9) |
< 2 years | 30 (41) | 40 (61) | 12 (30) | 14 (23) |
2–5 years | 25 (34) | 13 (21) | 6 (15) | 28 (46) |
> 5 years | 19 (26) | 13 (20) | 23 (56) | 19 (31) |
Range | 0–13 | 0–12 | 0–15 | 0–18 |
Treatment received | ||||
Radiotherapy | 26 (35) | 16 (24) | 10 (24) | 0 (0) |
Chemotherapy | 73 (97) | 64 (97) | 33 (81) | 33 (52) |
Stem cell transplantation | 6 (8) | 3 (5) | 2 (5) | 0 (0) |
Monoclonal anti bodies | 0 (0) | 41 (62) | 21 (51) | 12 (19) |
Active surveillance | 0 (0) | 1 (2) | 6 (15) | 34 (54) |
On treatment at time of issue list | ||||
Yes | 10 (14) | 23 (35) | 16 (39) | 17 (27) |
Stage | ||||
Ann Arbour/RAI | Ann Arbour | Ann Arbour | Ann Arbour | RAI |
I/0 | 5 (7) | 16 (24) | 2 (5) | 14 (22) |
II/1 | 33 (44) | 8 (12) | 6 (15) | 4 (6) |
III/2 | 21 (28) | 6 (9) | 6 (15) | 6 (10) |
IV/3 | 6 (8) | 21 (32) | 17 (42) | 4 (6) |
/4 | – | – | – | 2 (3) |
Unknown | 10 (13) | 15 (23) | 10 (24) | 33 (52) |
Phase 2: operationalization of the provisional questionnaire
Phase 3: pretesting of the provisional questionnaire for relevance and acceptability
HL (N = 67) | HG-NHL (N = 117) | LG-NHL (N = 67) | CLL (N = 86) | |
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Country (language) | ||||
Austria (German) | 2 (3) | 10 (9) | 1 (2) | 1 (1) |
France (French) | 10 (15) | 32 (27) | 19 (28) | 15 (17) |
Italy (Italian) | 16 (24) | 28 (24) | 12 (18) | 32 (37) |
Netherlands (Dutch) | 21 (31) | 26 (22) | 16 (24) | 18 (21) |
UK (English) | 18 (27) | 21 (18) | 19 (28) | 20 (23) |
Age (years) | ||||
Mean (SD) | 44 (16) | 59 (17) | 65 (11) | 69 (10) |
Range | 18–79 | 23–89 | 34–87 | 35–87 |
Sex | ||||
Male | 32 (48) | 68 (58) | 36 (54) | 59 (69) |
Female | 35 (52) | 49 (42) | 31 (46) | 27 (31) |
Time since diagnosis (years) | ||||
Mean (SD) | 5.6 (7.1) | 2.8 (3.2) | 3.9 (4.1) | 5.0 (4.4) |
< 2 year | 20 (30) | 52 (44) | 24 (36) | 20 (23) |
2–5 years | 24 (36) | 45 (39) | 27 (40) | 30 (35) |
> 5 years | 22 (33) | 19 (16) | 16 (24) | 35 (41) |
Treatment received | ||||
Radiotherapy | 31 (46) | 19 (16) | 5 (8) | 0 (0) |
Chemotherapy | 66 (99) | 113 (97) | 61 (91) | 51 (59) |
Stem cell transplantation | 11 (16) | 20 (17) | 5 (8) | 1 (1) |
Monoclonal antibodies | 3 (5) | 54 (47) | 33 (49) | 24 (28) |
Active surveillance | 6 (9) | 17 (15) | 15 (22) | 38 (44) |
No. of treatment lines | ||||
One line | 34 (51) | 70 (60) | 38 (57) | 62 (72) |
Two or more lines | 33 (49) | 46 (40) | 29 (43) | 24 (28) |
On treatment at time of issue list | ||||
Yes | 26 (39) | 56 (48) | 45 (67) | 45 (52) |
No | 41 (61) | 60 (52) | 21 (31) | 31 (36) |
Stage of disease | ||||
Ann Arbour/RAI | Ann Arbour | Ann Arbour | Ann Arbour | RAI |
I/0 | 8 (12) | 7 (6) | 5 (8) | 24 (28) |
II/1 | 23 (34) | 10 (9) | 3 (5) | 8 (9) |
III/2 | 14 (21) | 24 (21) | 12 (18) | 14 (16) |
IV/3 | 13 (19) | 44 (38) | 35 (52) | 13 (15) |
4 | – | – | – | 6 (7) |
Unknown/not determined | 9 (13) | 32 (28) | 12 (18) | 21 (24) |
Comorbidity | ||||
Yes | 35 (52) | 71 (61) | 50 (75) | 63 (73) |
Karnofsky score | ||||
0–40% | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
50–70% | 7 (10) | 20 (17) | 6 (9) | 8 (9) |
80–100% | 56 (84) | 81 (69) | 58 (87) | 74 (86) |
Missing | 4 (6) | 15 (13) | 3 (5) | 4 (5) |
Living arrangement | ||||
Living with partner/family | 45 (75) | 77 (68) | 46 (69) | 61 (71) |
Living with others | 11 (18) | 26 (23) | 12 (18) | 12 (14) |
Living alone | 2 (3) | 11 (10) | 7 (10) | 11 (13) |
Education | ||||
No or primary school | 3 (5) | 11 (10) | 10 (15) | 20 (23) |
Secondary education | 27 (40) | 49 (43) | 31 (46) | 34 (40) |
Pre-university training | 31 (51) | 54 (47) | 23 (34) | 29 (34) |
Employment | ||||
Yes | 28 (45) | 36 (31) | 18 (29) | 15 (17) |
No (incl. retired, homemaker) | 34 (55) | 76 (69) | 45 (71) | 66 (83) |
EORTC QLQ-HL27 | EORTC QLQ-NHL-HG29 | EORTC QLQ-NHL-LG20 | EORTC QLQ-CLL17 | |
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Each item is rated on a four-point scale: not at all, a little, quite a bit and very much | ||||
31. Have you had muscle weakness? |
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32. Have you had aches or pains in your muscles or joints? |
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33. Have you had aches or pain in your bones? |
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34. Have you had a dry cough? |
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35. Have you had a dry mouth? |
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36. Have you had problems with your sense of taste? |
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37. Have you lost any hair? | ||||
38. Answer this question only if you lost any hair: have you been upset by the loss of your hair? | ||||
39. Have you had vulnerable veins (for example, when having blood taken or receiving treatment)? |
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40. Have you felt ill or unwell? |
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41. Have you had itching of your skin? |
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42. Have you had night sweats? |
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43. Have you lost weight? | ||||
44. Have you had tingling hands or feet? |
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45. Have you had numbness in your fingers or toes? |
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46. Have you had shortness of breath on exertion? |
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47. Have you felt you had setbacks in your physical condition? |
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48. Have you had a lack of energy? |
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49. Have you felt drowsy? |
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50. Have you had sudden tiredness? |
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51. Have you had mood changes? |
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52. Have you felt a lack of confidence in your body? |
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53. Have you felt restless or agitated? |
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54. Have you been dissatisfied with how your body functions? |
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55. Have you lacked self-confidence? |
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56. Have you had difficulty accepting limitations due to the disease? |
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57. Have you worried about dying? | ||||
58. Have you worried about picking up an infection? |
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59. Have you worried about your health in the future? |
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60. Have you worried about recurrence of your disease? |
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61. Have you worried about becoming chronically ill? |
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62. Have you worried about becoming dependent on others? |
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63. Have you worried about getting another type of cancer? |
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64. Have you worried about your treatment causing future health problems? |
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65. Have you worried about damage to your heart and blood vessels? |
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66. If applicable: Have you had problems at your work or place of study due to the disease? |
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67. If applicable: Have you worried about not being able to continue working or your education? |
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68. If applicable: Have you been concerned about your ability to have children? |
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Total items to include |
27
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29
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20
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17
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Hodgkin lymphoma
High-grade (HG: aggressive) non-Hodgkin lymphoma
Low-grade (LG: indolent) non-Hodgkin lymphoma
Chronic lymphocytic leukaemia
Proposed scale structure
Scale | Item | Cronbach’s α | Total sample | On treatment | Off treatment | ≤ median age | > median age |
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Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |||
EORTC QLQ-HL27 |
N = 67 |
N = 26 |
N = 41 |
N = 34 (median age = 47) |
N = 33 (median age = 47) | ||
Symptom burden due to disease and/or treatment | Six items: 31–33, 36, 39, 41 | 0.71 | 22.2 (19) | 26.2 (19) | 19.7 (19) | 18.2 (18) | 26.3 (19) |
Physical condition/fatigue | Four items: 46, 48–50 | 0.84 | 27.5 (25) | 27.3 (25) | 27.6 (26) | 23.2 (24) | 31.7 (26) |
Emotional impacts | Six items: 51–56 | 0.89 | 22.6 (23) | 25.2 (19) | 21.0 (26) | 23.7 (26) | 21.5 (20) |
Worries/fears health and functioning | 11 items: 58–68 | 0.91/0.92a
| 29.8 (26)/ 31.2 (27)a
| 34.1 (26)/ 33.6 (24)a
| 29.3 (28)/ 27.4 (27)a
| 34.2 (29)/ 34.1 (27) | 28.1 (26)/ 25.4 (24) |
Scale | Item | Cronbach’sα | Total sample | On treatment | Off treatment | ≤ median age | > median age |
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Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |||
EORTC QLQ-NHL-HG29 |
N = 117 |
N = 56 |
N = 60 |
N = 61 (median age = 61) |
N = 56 (median age = 61) | ||
Symptom burden due to disease and/or treatment | Seven items: 31–36, 40 | 0.77 | 27.3 (20) | 33.2 (20) | 22.2 (19) | 30.1 (21) | 24.4 (18) |
Neuropathy | Two items: 44, 45 | 0.88 | 21.9 (28) | 26.7 (28) | 17.3 (28) | 23.2 (29) | 20.4 (27) |
Physical condition/fatigue | Five items: 46–50 | 0.86 | 30.6 (25) | 35.9 (20) | 25.9 (23) | 35.8 (25) | 24.7 (23) |
Emotional impacts | Four items: 51, 52, 54, 56 | 0.87 | 23.7 (25) | 28.0 (27) | 20.0 (22) | 30.2 (26) | 16.7 (22) |
Worries/fears health and functioning | 11 items: 58–68 | 0.90/0.90a
| 31.6 (25)/ 29.8 (24)a
| 35.5 (25)/ 33.5 (24)a
| 27.8 (25)/ 26.3 (25)a
| 40.2 (25)/ 39.4 (24) | 22.2 (21)/ 19.3 (19) |
Scale | Item | Cronbach’s α | Total sample | On treatment | Off treatment | ≤ median age | > median age |
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Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |||
EORTC QLQ-NHL-LG20 |
N = 67 |
N = 45 |
N = 21 |
N = 38 (median age = 65) |
N = 29 (median age = 65) | ||
Symptom burden due to disease and/or treatment | Four items: 31, 32, 35, 36 | 0.67 | 24.1 (23) | 27.8 (23) | 16.8 (21) | 21.1 (23) | 28.0 (22) |
Physical condition/Fatigue | Four items: 46, 48–50 | 0.80 | 25.0 (23) | 29.3 (22) | 16.7 (24) | 23.9 (24) | 26.4 (23) |
Emotional impacts | Four items: 52–54, 56 | 0.87 | 22.5 (25) | 26.6 (25) | 14.7 (22) | 22.1 (25) | 22.9 (25) |
Worries/fears health and functioning | Eight items: 58–60, 62–64, 66, 67 | 0.87/0.89a
| 30.1 (26)/ 29.7 (25)a
| 34.6 (27)/ 34.4 (27)a
| 22.0 (18)/ 21.0 (19)a
| 29.9 (25)/ 30.0 (24) | 30.4 (27)/ 29.3 (27) |
Scale | Item | Cronbach’s α | Total sample | On treatment | Off treatment | ≤ median age | > median age |
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Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |||
EORTC QLQ-CLL17 |
N = 86 |
N = 45 |
N = 31 |
N = 47 (median age = 70) |
N = 39 (median age = 70) | ||
Symptom burden due to disease and/or treatment | Six items: 31–33, 35, 40, 42 | 0.85 | 25.2 (25) | 25.4 (24) | 23.7 (27) | 29.5 (25) | 20.0 (23) |
Physical condition/Fatigue | Four items: 46, 48–50 | 0.87 | 25.4 (26) | 28.8 (26) | 21.0 (26) | 28.6 (29) | 21.6 (20) |
Worries/fears health and functioning | Seven items: 59, 60, 62–64, 66, 67 | 0.88/0.86a
| 26.9 (25)/ 25.2 (25)a
| 33.9 (28)/ 32.3 (28) | 18.7 (18)/ 16.8 (17) | 33.9 (28)/ 32.3 (28) | 18.7 (18)/ 16.8 (17) |