Introduction
Patients and methods
Patients
-
before starting adjuvant or palliative chemotherapy (all fluoropyrimidine based regimens) (chemotherapy group),
-
before starting preoperative radiotherapy for rectal cancer (radiotherapy group): Preoperative radiotherapy delivered 45 grays in 25 fractions (five weeks) with or without concomitant fluoropyrimidine.
Measures and data collection procedure
-
Patients treated by adjuvant or palliative chemotherapy were asked to complete all questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38 and FACT-C) before the first, the third and the fourth courses of chemotherapy administered at 2 weeks interval.
-
Patients treated by preoperative radiotherapy for rectal cancer were asked to fill the three questionnaires before the first fraction and during the last week of radiotherapy.
Statistical analysis
Results
Sociodemographic and clinical data
Chemotherapy Group | Radiotherapy Group | p | Total | |
---|---|---|---|---|
N
|
71
|
56
|
127
| |
Age (years)
| 60 | 66 | 0.001 | 64 |
Median | ||||
Gender (%)
| ||||
Men | 38 (53) | 43 (77) | 0.007 | 81 (64) |
Women | 33 (47) | 13 (23) | 46 (36) | |
Marital status (%)
| ||||
Single | 3 (4) | 4 (7) | 7 (6) | |
Married | 53 (69) | 44 (80) | 0.52 | 97 (76) |
Widower | 7 (6) | 5 (4) | 12 (9) | |
Divorced | 8 (21) | 3 (9) | 11 (6) | |
Localisation (%)
| ||||
Colon | 55 (76) | 1 (2) | < .0001 | 56 (44) |
Rectum | 16 (24) | 55 (98) | 71 (56) | |
Disease status (%)
| ||||
Non metastatic | 30 (42) | 50 (89) | 80 (63) | |
Metastatic | 40 (56) | 5 (9) | < .0001 | 45 (35) |
Unknown | 1 (2) | 1 (2) | 2 (2) |
Test-retest reliability
n | ICCa
| 95% CIb
| |
---|---|---|---|
EORTC QLQ-C30:
| |||
Functional scales:
| |||
Physical function | 34 | 0.87 | 0.76-0.93 |
Role function | 33 | 0.80 | 0.64-0.90 |
Emotional function | 34 | 0.73 | 0.52-0.85 |
Cognitive function | 34 | 0.79 | 0.62-0.89 |
Social function | 34 | 0.84 | 0.71-0.92 |
Global QoL/GHS | 34 | 0.33 | -0.01-0.59 |
Symptom scales:
| |||
Fatigue | 34 | 0.82 | 0.67-0.90 |
Pain | 34 | 0.74 | 0.54-0.86 |
Nausea and vomiting | 34 | 0.43 | 0.11-0.67 |
Single items
c
:
| |||
Dyspnoea | 34 | 0.63 | 0.37-0.79 |
Sleep disturbance | 34 | 0.76 | 0.58-0.87 |
Appetite loss | 34 | 0.74 | 0.54-0.86 |
Diarrhoea | 34 | 0.33 | -0.003-0.60 |
Constipation | 34 | 0.54 | 0.25-0.74 |
Financial impact | 34 | 0.75 | 0.56-0.87 |
EORTC QLQ-CR38:
| |||
Functional scales:
| |||
Body image | 32 | 0.71 | 0.49-0.85 |
Future perspective | 32 | 0.76 | 0.56-0.87 |
Sexual functioning | 31 | 0.82 | 0.66-0.91 |
Sexual enjoyment | 11 | NA | NA |
Symptom scales:
| |||
Radiation-induced effects micturition | 32 | 0.67 | 0.43-0.82 |
Chemotherapy side effects | 32 | 0.70 | 0.47-0.84 |
General gastrointestinal symptoms | 32 | 0.65 | 0.39-0.81 |
Defecation problems | 26 | NA | NA |
Stoma-related problems | 6 | NA | NA |
Sexual dysfunction of men | 14 | NA | NA |
Sexual dysfunction of women | 3 | NA | NA |
Weight loss | 32 | 0.36 | 0.02-0.63 |
FACT-C:
| |||
Physical Well-Being | 34 | 0.76 | 0.57-0.87 |
Social/Family Well-Being | 33 | 0.51 | 0.23-0.73 |
Emotional Well-Being | 34 | 0.79 | 0.62-0.89 |
Functional Well-Being | 34 | 0.73 | 0.52-0.85 |
Colorectal Cancer Specific | 34 | 0.77 | 0.59-0.90 |
FACT-C total score | 34 | 0.75 | 0.55-0.87 |
Trial Outcome Index-Colorectal | 34 | 0.82 | 0.66-0.90 |
Description of the QoL scores and responsiveness of the questionnaires
- Chemotherapy group
Description of scores (Table 3)
n | Score before 1stchemother.Mean (SD a) | Difference Mean (SD a) | Pb
| SRMc (CI 95%) | ESd (CI 95%) | |
---|---|---|---|---|---|---|
EORTC QLQ-C30:
| ||||||
Functional scales
e
: | ||||||
Physical function | 16 | 67.8 (30.2) | +14.9 (22.5) |
0.02
| 0.64 (0.19;1.08) | 0.48 (0.14;0.86) |
Role function | 16 | 55.9 (39.1) | +21.9 (16.7) |
0.03
| 0.60 (0.08;1.13) | 0.56 (0.10;1.07) |
Emotional function | 17 | 69.6 (16.1) | +16.2 (16.7) |
0.003
| 0.84 (0.28;1.54) | 1.00 (0.35;1.68) |
Cognitive function | 17 | 77.5 (20.4) | +10.8 (16.6) |
0.02
| 0.64 (0.16;1.29) | 0.52 (0.14;1.09) |
Social function | 17 | 62.7 (34.1) | +13.7 (38.3) | 0.16 | 0.35 (-0.17;0.88) | 0.40 (-0.20;0.89) |
Global QoL/GHS | 17 | 54.9 (20) | +14.2 (14.7) |
0.001
| 0.96 (0.38;1.67) | 0.71 (-0.23;1.44) |
Symptom scales
f
: | ||||||
Fatigue | 16 | 42.8 (27.9) | -16.3 (25.8) |
0.02
| - 0.63 (-1.07;-0.19) | - 0.58 (-1.13;-0.15) |
Pain | 17 | 28.4 (31) | -17.6 (37.5) | 0.07 | - 0.47 (-0.90;-0.09) | - 0.56 (-1.07;-0.05) |
Nausea and vomiting | 16 | 12.7 (22.5) | -6.2 (21.8) | 0.27 | - 0.28 (-0.69;0.28) | - 0.27 (-0.66;0.25) |
Single items
f
: | ||||||
Dyspnoea | 16 | 21.6 (26.2) | -8.3 (25.8) | 0.22 | - 0.32 (-1.05;0.65) | - 0.31 (-0.89;0.17) |
Sleep disturbance | 16 | 45.1 (31) | -12.5 (38.2) | 0.21 | - 0.32 (-0.86;0.19) | - 0.40 (-0.98;0.38) |
Appetite loss | 16 | 29.4 (30.9) | -12.5 (26.9) | 0.08 | - 0.46 (-0.93;0.01) | - 0.40 (-0.87;0.08) |
Diarrhoea | 17 | 19.6 (23.7) | +3.9 (33.1) | 0.63 | 0.11 (-0.38;0.64) | 0.16 (-0.41;1.17) |
Constipation | 17 | 17.6 (29.1) | -5.9 (27.0) | 0.38 | - 0.21 (-0.75;0.31) | - 0.20 (-0.67;0.31) |
Financial impact | 17 | 5.9 (17.6) | +3.9 (11.1) | 0.16 | 0.35 (0.11;0.57) | 0.22 (-0.05;0.49) |
EORTC QLQ-CR38:
| ||||||
Functional scales
e
: | ||||||
Body image | 16 | 81.7 (28) | +3.8 (14.2) | 0.30 | 0.27 (-0.33;0.69) | 0.13 (-0.13;0.37) |
Future perspective | 16 | 45.1 (28.7) | +22.9 (31.5) |
0.01
| 0.70 (0.27;1.27) | 0.79 (0.27;1.38) |
Sexual functioning | 14 | 20.2 (20.9) | +5.9 (16.8) | 0.21 | 0.37 (-0.28;0.86) | 0.28 (-0.15;0.83) |
Sexual enjoyment | 7 | 54.2 (43.4) | +9.5 (41.8) | 0.57 | 0.23 (-0.56;1.28) | 0.21 (-0.73;0.91) |
Symptom scales
f
: | ||||||
Radiation-induced effects micturition | 16 | 23.5 (15.2) | +4.8 (15.7) | 0.23 | 0.30 (-0.23;0.91) | 0.32 (-0.23;0.89) |
Chemotherapy side effects | 16 | 18.6 (19.5) | +4.2 (18.4) | 0.38 | 0.23 (-0.30;1.1) | 0.21 (-0.77;0.92) |
General Gastrointestinal symptoms | 16 | 23.0 (12) | -7.0 (14.3) | 0.07 | -0.49 (-1.38;0.11) | - 0.58 (-1.45;0.17) |
Defecation problems | 13 | 15.4 (11.5) | -1.8 (8.2) | 0.43 | -0.22 (-1.10;0.41) | - 0.16 (-0.65;0.32) |
Stoma-related problems | 4 | 31.0 (21.5) | -1.2 (13.7) | 0.87 | -0.10 (-1.15;1.02) | - 0.05 (-1.96;2.43) |
Sexual dysfunction of men | 8 | 43.8 (41.7) | -2.1 (35.0) | 0.87 | -0.06 (-1.43;0.82) | - 0.04 (0.84;0.64) |
Sexual dysfunction of women | 2 | 8.3 (11.8) | -8.3 (11.8) | 0.50 | -0.70 (-1.44;-0.31) | -0.70 (-1.44;-0.31) |
Weight loss | 16 | 25.5 (34.4) | -22.9 (33.8) |
0.02
| -0.67 (-1.01;-0.35) | - 0.66 (-1.01;-0.36) |
FACT-C
e
: | ||||||
Physical Well-Being | 17 | 78.0 (15.3) | +5.3 (15.8) | 0.18 | 0.34 (-0.20;0.85) | 0.34 (-0.17;0.87) |
Social/Family Well-Being | 17 | 74.3 (21.1) | +3.2 (18.3) | 0.48 | 0.17 (0.47;0.59) | 0.15 (-0.39;0.48) |
Emotional Well-Being | 17 | 74.3 (19.6) | +3.3 (13.7) | 0.34 | 0.24 (-0.32;0.64) | 0.16 (-0.16;0.48) |
Functional Well-Being | 17 | 50.8 (17.1) | +10.0 (13.2) |
0.007
| 0.75 (0.20;1.27) | 0.58 (0.19;0.93) |
Colorectal Cancer Specific | 16 | 69.6 (10.6) | +3.9 (12.9) | 0.25 | 0.30 (-0.26;0.88) | 0.36 (-0.27;0.98) |
FACT-C total score | 17 | 69.5 (8.6) | +1.6 (9.0) | 0.49 | 0.19 (-0.36;0.71) | 0.18 (-0.35;0.81) |
Trial Outcome Index-Colorectal | 17 | 66.4 (10.6) | +4.7 (13.0) | 0.152 | 0.36 (-0.20;0.96) | 0.44 (-0.29;0.99) |
Responsiveness (Table 3)
- Radiotherapy group
Description of scores (Table 4)
n | Score before radiotherapy Mean (SDa) | Difference Mean (SDa) | Pb
| SRMc (CI 95%) | ESd (CI 95%) | |
---|---|---|---|---|---|---|
EORTC QLQ-C30:
| ||||||
Functional scales
e
: | ||||||
Physical function | 22 | 83.9 (18.4) | -6.5 (16.4) | 0.08 | - 0.39 (-0.78;0.02) | - 0.35 (-0.85;0.21) |
Role function | 21 | 74.6 (27.2) | -6.3 (28.1) | 0.07 | - 0.22 (-0.74;0.22) | -0.23 (-0.78;0.21) |
Emotional function | 22 | 79.2 (17.8) | +3.8 (14.2) | 0.23 | 0.26 (-0.19;0.67) | 0.21 (-0.15;0.57) |
Cognitive function | 22 | 94.7 (7.9) | -4.5 (15.6) | 0.19 | - 0.29 (-0.67;0.17) | - 0.57 (-0.55;0.21) |
Social function | 22 | 78.8 (24.2) | -5.3 (22.0) | 0.27 | - 0.24 (-0.69;0.21) | - 0.21 (-0.78;0.16) |
Global QoL/GHS | 22 | 54.9 (22.7) | +5.7 (26.4) | 0.32 | 0.21 (-0.32;0.53) | 0.25 (-0.24;0.75) |
Symptom scales
f
: | ||||||
Fatigue | 22 | 38.9 (25.1) | +2.0 (28.4) | 0.74 | 0.07 (-0.37;0.56) | 0.08 (-0.37;0.70) |
Pain | 22 | 23.5 (23.9) | +8.3 (27.6) | 0.17 | 0.30 (-0.16;0.84) | 0.34 (-0.16;1.04) |
Nausea and vomiting | 22 | 2.3 (7.8) | +3.0 (12.2) | 0.26 | 0.24 (-0.21;0.70) | 0.38 (-0.75;1.33) |
Single items
f
: | ||||||
Dyspnoea | 21 | 11.1 (16.1) | 0.0 (14.9) | 1.00 | 0.0 (-0.52;0.44) | 0.0 (-0.41;0.38) |
Sleep disturbance | 22 | 28.8 (34.6) | -7.6 (35.5) | 0.33 | - 0.21 (-0.62;0.30) | - 0.21 (-0.64;0.30) |
Appetite loss | 21 | 20.6 (28.8) | +4.8 (35.4) | 0.54 | 0.13 (-0.31;0.66) | 0.16 (-0.32;0.91) |
Diarrhoea | 22 | 28.8 (31.4) | -1.5 (33.3) | 0.83 | - 0.04 (-0.56;0.39) | - 0.04 (-0.48;0.56) |
Constipation | 22 | 15.2 (24.6) | +12.1 (24.2) |
0.03
| 0.50 (0.06;0.97) | 0.49 (0.06;1.20) |
Financial impact | 21 | 10.6 (26.0) | +5.7 (26.4) | 0.33 | 0.22 (0.17;0.31) | 0.06 (-0.15;0.24) |
EORTC QLQ-CR38:
| ||||||
Functional scales
e
: | ||||||
Body image | 20 | 90.9 (16.3) | -3.3 (14.5) | 0.32 | - 0.23 (-0.7;0.27) | - 0.20 (-0.81;0.50) |
Future perspective | 21 | 56.1 (26.0) | +4.8 (21.8) | 0.33 | 0.21 (-0.23;0.72) | 0.18 (-0.21;0.57) |
Sexual functioning | 20 | 16.7 (27.9) | -5.8 (21.8) | 0.24 | - 0.26 (-0.76;0.19) | - 0.20 (-0.54;0.17) |
Sexual enjoyment | 10 | 33.3 (49.4) | -26.7 (30.6) |
0.02
| - 0.87 (-1.79;-0.45) | - 0.53 (-1.03;-0.15) |
Symptom scales
f
: | ||||||
Radiation-induced effects micturition | 21 | 21.7 (22.6) | +19.3 (21.9) |
0.0006
| 0.88 (0.42;1.44) | 0.85 (0.36;1.50) |
Chemotherapy side effects | 21 | 15.2 (23.6) | +5.3 (13.0) | 0.08 | 0.40 (-0.11;0.89) | 0.22 (-0.15;0.55) |
General Gastrointestinal symptoms | 21 | 26.7 (14.9) | -0.4 (11.9) | 0.88 | - 0.03 (-0.50;0.46) | 0.02 (-0.38;0.36) |
Defecation problems | 19 | 37.6 (21.6) | -1.5 (14.8) | 0.66 | - 0.10 (-0.59;0.41) | - 0.07 (-0.42;0.27) |
Stoma-related problems | 1 | 9.5 (00.0) | +23.8 (-) | - | - | - |
Sexual dysfunction of men | 9 | 35.9 (44.5) | +7.4 (20.6) | 0.31 | 0.35 (-0.28;1.09) | 0.16 (-0.09;0.65) |
Sexual dysfunction of women | 2 | 16.7 (23.6) | +16.7 (0.0) | 1.00 | 0 | 0.70 (0.65;1.10) |
Weight loss | 21 | 28.8 (34.6) | +1.6 (38.7) | 0.85 | 0.04 (-0.40;0.55) | 0.04 (-0.43;0.67) |
FACT-C
e
: | ||||||
Physical Well-Being | 19 | 81.4 (16.4) | -5.0 (14.3) | 0.15 | - 0.34 (-0.77;0.17) | - 0.30 (-0.94;0.10) |
Social/Family Well-Being | 19 | 71.3 (25.7) | -7.4 (16.2) | 0.06 | - 0.45 (-0.96;0.09) | - 0.28 (-0.63;0.03) |
Emotional Well-Being | 19 | 77.5 (17.6) | 0 (12.7) | 1.00 | 0.0 (-0.78;0.31) | 0.0 (-0.34;0.37) |
Functional Well-Being | 18 | 50.1 (20.0) | -2.5 (17.1) | 0.55 | - 0.14 (-0.71;0.40) | - 0.12 (-0.56;0.35) |
Colorectal Cancer Specific | 19 | 67.7 (11.5) | -3.2 (12.3) | 0.27 | - 0.26 (-0.64;0.24) | - 0.28 (-0.80;0.18) |
FACT-C total score | 19 | 69.1 (11.4) | -3.0 (8.5) | 0.14 | - 0.35 (-0.96;0.19) | - 0.26 (-0.64;0.15) |
Trial Outcome Index-Colorectal | 19 | 65.7 (13.7) | -2.6 (10.2) | 0.29 | - 0.25 (-0.78;0.31) | - 0.18 (-0.60;0.20) |