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Table 2 Mean quality of life scores (EORTC QLQ-C30, -CX24 and -EN24) with standard deviations (SD) at each time point

From: Health-related quality of life and patient-reported symptoms after postoperative proton beam radiotherapy of cervical and endometrial cancer: 2-year results of the prospective phase II APROVE-trial

Score

Baseline

End of RT

6 weeks after RT

3 months after RT

6 months after RT

1 year after RT

2 years after RT

N

Mean (± SD)

N

Mean (± SD)

p value

N

Mean (± SD)

N

Mean (± SD)

N

Mean (± SD)

N

Mean (± SD)

N

Mean (± SD)

p value

EORTC QLQ-C30

Global health status/QoL

24

58.0 (± 20.1)

23

61.6 (± 21.2)

0.573

24

66.0 (± 20.4)

23

66.7 (± 22.0)

24

65.6 (± 19.1)

24

62.8 (± 24.2)

18

69.9 (± 19.3)

 0.036b

Functional scales (higher scores indicate a better QoL)

 Physical functioning

25

73.9 (± 24.1)

24

73.3 (± 23.9)

0.472

25

72.3 (± 21.0)

23

74.5 (± 21.7)

25

73.6 (± 21.3)

24

73.3 (± 21.8)

17

71.8 (± 26.3)

0.095

 Role functioning

25

55.3 (± 34.2)

24

56.9 (± 31.1)

0.422

25

63.3 (± 28.3)

23

63.8 (± 30.9)

25

72.0 (± 27.4)

24

67.4 (± 25.7)

17

64.7 (± 29.6)

0.174

 Emotional functioning

25

60.7 (± 30.5)

23

73.2 (± 24.2)

0.004

24

73.6 (± 24.0)

23

68.1 (± 21.7)

24

72.9 (± 24.0)

24

67.0 (± 26.8)

17

63.7 (± 27.9)

0.154

 Cognitive functioning

25

80.0 (± 24.0)

23

82.6 (± 21.1)

0.500

24

79.2 (± 22.2)

23

79.0 (± 23.2)

24

76.4 (± 26.3)

24

77.8 (± 24.8)

17

71.6 (± 31.2)

0.335

 Social functioning

25

62.0 (± 33.5)

23

78.3 (± 24.8)

0.008c

24

76.4 (± 25.0)

23

75.4 (± 26.9)

24

72.2 (± 25.8)

24

70.1 (± 25.9)

17

68.6 (± 29.1)

0.094

Symptom scales (higher scores indicate more problems)

 Fatigue

25

48.4 (± 26.6)

24

50.5 (± 27.8)

0.363

25

43.6 (± 28.1)

23

38.2 (± 27.8)

25

37.3 (± 26.6)

24

40.3 (± 26.6)

17

35.9 (± 26.0)

0.030a

 Nausea and vomiting

25

8.0 (± 18.9)

24

15.3 (± 20.4)

0.142

25

6.0 (± 10.4)

23

8.0 (± 16.2)

25

5.3 (± 11.3)

24

11.8 (± 21.8)

17

5.9 (± 11.3)

0.402

 Pain

25

34.0 (± 31.1)

24

34.0 (± 26.6)

0.453

25

32.0 (± 27.9)

23

35.5 (± 29.2)

25

33.3 (± 33.3)

24

38.2 (± 33.5)

17

30.4 (± 29.3)

0.294

 Dyspnoea

23

23.2 (± 28.5)

24

34.7 (± 31.1)

0.035b

25

34.7 (± 25.8)

23

24.6 (± 22.5)

25

29.3 (± 25.5)

24

33.3 (± 25.5)

17

25.5 (± 29.2)

0.135

 Insomnia

25

53.3 (± 35.3)

24

41.7 (± 35.0)

0.108

25

40.0 (± 35.3)

23

42.0 (± 22.5)

25

44.0 (± 34.9)

24

48.6 (± 31.9)

17

52.9 (± 39.7)

0.266

 Appetite loss

25

22.7 (± 30.9)

23

24.6 (± 29.8)

0.266

25

12.0 (± 18.6)

23

11.6 (± 25.3)

25

12.0 (± 20.8)

24

16.7 (± 25.5)

16

12.5 (± 20.0)

0.191

 Constipation

25

37.3 (± 36.9)

24

33.3 (± 37.3)

0.203

24

25.0 (± 30.8)

23

27.5 (± 30.5)

23

36.2 (± 33.9)

24

29.2 (± 36.4)

17

29.4 (± 32.1)

0.430

 Diarrhoe

25

13.3 (± 23.1)

22

22.7 (± 30.8)

0.105

24

11.1 (± 15.7)

23

14.5 (± 21.6)

24

11.1 (± 15.7)

24

15.3 (± 28.8)

17

13.7 (± 20.0)

0.254

 Financial difficulties

25

14.7 (± 25.1)

22

21.7 (± 28.8)

0.154

24

23.6 (± 28.0)

21

23.8 (± 31.1)

24

22.2 (± 28.3)

24

22.2 (± 29.9)

17

21.6 (± 30.1)

0.107

EORTC QLQ-CX24

Functional scales (higher scores indicate a better QoL)

 Body image

8

73.6 (± 24.2)

7

81.0 (± 22.8)

0.443

8

65.3 (± 27.5)

8

70.8 (± 20.7)

8

69.4 (± 22.0)

6

75.9 (± 23.5)

5

53.3 (± 27.6)

0.179

 Sexual activity

8

8.3 (± 22.0)

7

25.0 (± 25.0)

0.178

7

14.3 (± 16.5)

7

19.0 (± 24.3)

5

20.0 (± 26.7)

6

27.8 (± 22.9)

4

6.7 (± 13.3)

0.352

 Sexual enjoyment

1

100.0 (± 0.0)

1

47.6 (± 35.0)

NA

2

33.3 (± 33.3)

3

66.7 (± 27.2)

2

83.3 (± 25.2)

4

66.7 (± 23.6)

1

100.0 (± 0.0)

NA

 Sexual/vaginal functioning

1

58.3 (± 0.0)

1

75.0 (± 0.0)

0.104

2

50.0 (± 25.0)

3

47.2 (± 25.8)

2

54.2 (± 29.2)

4

56.3 (± 23.8)

1

83.3 (± 0.0)

0.305

Symptom scales (higher scores indicate more problems)

 Symptom experience

8

19.7 (± 12.9)

7

23.8 (± 9.9)

0.188

7

22.1 (± 13.4)

7

17.3 (± 15.5)

8

16.7 (± 13.8)

6

11.4 (± 7.2)

4

20.5 (± 8.7)

0.277

 Lymphoedema

8

16.7 (± 23.6)

7

33.3 (± 39.8)

0.267

8

60.4 (± 37.2)

8

41.7 (± 36.3)

8

37.5 (± 30.9)

6

25.0 (± 14.4)

5

53.3 (± 26.7)

0.017

 Peripheral neuropathy

8

8.3 (± 14.4)

7

11.1 (± 24.8)

0.499

8

4.2 (± 11.0)

8

16.7 (± 23.6)

8

20.8 (± 23.2)

6

16.7 (± 28.9)

5

0.0 (± 0.0)

0.284

 Menopausal symptoms

8

37.5 (± 30.9)

7

47.6 (± 39.3)

0.284

7

19.0 (± 35.0)

7

42.9 (± 38.7)

8

50.0 (± 28.9)

6

41.7 (± 27.6)

4

16.7 (± 28.9)

0.359

 Sexual worry

8

58.3 (± 36.3)

7

23.8 (± 34.3)

0.055

7

33.3 (± 39.8)

6

44.4 (± 45.8)

6

38.9 (± 40.4)

5

33.3 (± 40.8)

2

50.0 (± 50.0)

0.397

EORTC QLQ-EN24

Functional scales (higher scores indicate a better QoL)

 Sexual interest

16

20.8 (± 28.6)

15

28.9 (± 29.5)

0.104

17

35.4 (± 27.6)

14

35.7 (± 26.6)

16

25.0 (± 25.0)

13

30.8 (± 30.6)

8

22.2 (± 15.7)

0.305

 Sexual activity

15

13.3 (± 20.4)

16

25.0 (± 25.0)

0.048

15

26.7 (± 24.9)

13

25.6 (± 26.6)

16

22.9 (± 22.7)

14

26.2 (± 28.7)

8

12.5 (± 23.2)

0.086

 Sexual enjoyment

4

58.3 (± 27.6)

7

47.6 (± 35.0)

NA

9

66.7 (± 22.2)

7

71.4 (± 21.3)

7

66.7 (± 25.2)

6

83.3 (± 25.5)

3

55.6 (± 31.4)

NA

Symptom scales (higher scores indicate more problems)

 Lymphoedema

17

44.1 (± 37.0)

17

31.4 (± 29.6)

0.069

17

38.2 (± 33.7)

15

40.0 (± 28.4)

17

43.1 (± 33.4)

15

41.1 (± 34.4)

10

43.3 (± 34.3)

0.069

 Urological symptoms

17

19.1 (± 21.0)

16

25.5. (± 24.6)

0.175

17

25.5 (± 26.0)

15

23.9 (± 19.0)

16

17.7. (± 15.0)

14

22.6 (± 21.5)

8

37.5 (± 29.2)

0.175

 Gastrointestinal symptoms

17

18.8 (± 9.8)

16

29.6 (± 21.6)

0.016

17

20.0 (± 13.1)

15

25.3 (± 12.7)

16

23.8 (± 18.1)

14

22.4 (± 19.3)

8

27.5 (± 9.1)

0.016

 Poor body image

16

28.1 (± 30.5)

17

17.6 (± 21.7)

0.022

16

16.7 (± 25.7)

15

17.8 (± 23.1)

17

17.6 (± 23.9)

15

9.3 (± 16.9)

10

18.3 (± 20.3)

0.022

 Sexual/vaginal problems

5

26.7 (± 24.9)

8

19.8 (± 19.7)

0.121

10

34.4 (± 21.3)

8

34.7 (± 31.6)

9

33.3 (± 25.7)

8

34.7 (± 29.6)

3

33.3 (± 32.7)

0.121

 Pain in back and pelvis

17

21.6 (± 27.9)

16

29.2 (± 23.2)

0.048

17

35.3 (± 31.2)

14

38.1 (± 27.8)

16

43.8 (± 30.5)

14

40.5 (± 33.8)

8

33.3 (± 33.3)

0.048

 Tingling/numbness

17

51.0 (± 38.1)

17

41.2 (± 38.8)

0.144

16

47.9 (± 40.8)

15

46.7 (± 36.1)

17

45.1 (± 39.5)

14

50.0 (± 37.3)

9

44.4 (± 44.4)

0.144

 Muscular pain

16

41.7 (± 46.1)

16

27.1 (± 26.9)

0.075

16

39.6 (± 37.7)

15

33.3 (± 33.2)

15

41.7 (± 36.3)

14

40.5 (± 33.8)

7

47.6 (± 35.0)

0.075

 Hair loss

17

39.2 (± 46.1)

15

20.0 (± 34.0)

0.215

17

11.8 (± 22.7)

15

31.1 (± 39.4)

15

18.8 (± 33.3)

14

4.8 (± 11.7)

8

33.3 (± 37.3)

0.215

 Taste change

17

19.6 (± 29.6)

16

8.3 (± 18.6)

0.052

17

7.8 (± 18.2)

15

24.4 (± 35.4)

15

16.7 (± 31.2)

14

14.3 (± 30.1)

8

8.3 (± 14.4)

0.052

  1. A p value of less than 0.05 was considered statistically significant for comparison of values to baseline
  2. N number of available data, NA not assessable, QoL quality of life, RT radiotherapy
  3. aClinically relevant small difference
  4. bClinically relevant medium difference
  5. cClinically relevant large difference