Observational Study
Copyright ©The Author(s) 2023.
World J Methodol. Sep 20, 2023; 13(4): 259-271
Published online Sep 20, 2023. doi: 10.5662/wjm.v13.i4.259
Table 1 Patients clinical and demographic characteristics
Variables
Description
Age, mean ± SD55.65 ± 12.87
Sex
    Female98 (44.5%)
    Male123 (55.5%)
Tumor location
    Colon78 (35%)
    Rectum139 (62%)
Neoadjuvant chemoradiotherapy
    No107 (54,6%)
    Yes89 (45,5%)
Definitive stoma
    No50 (22.6%)
    Yes171 (77.4%)
Adjuvant chemotherapya
    Yes91 (70%)
    No39 (30%)
Table 2 Quality of life scores according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Quality of Life Questionnaire-CR29 structure and reliability
Scaling/single-item name
n
Item No.
Mean
SD
Floor
Ceiling
Range
ICC
EORTC QLQ-CR29
All patients 221
Urinary frequency31.3239.8933.4626.210.90-1000.961
Blood & mucus in stool38.3924.7329.0243.44.10-1000.969
(F) Body image45-4777.8224.831.8380-1000.950
Defecation/stoma problems49–54-----
Urinary incontinence3320.9632.2264.77.20-1000.982
Dysuria3420.6631.3063.36.80-1000.950
Abdominal pain3530.6134.12488.60-1000.922
Buttock pain3627.1434.6255.790-1000.921
Bloated feeling3728.8033.7750.28.60-1000.945
Dry mouth4024.5834.1460.28.60-1000.979
Hair loss4116.4429.5771.55.90-1000.968
Trouble with taste4220.5132.8967.08.10-1000.975
(F) Anxiety4364.6737.6016.743.40-1000.951
(F) Weight4475.5632.668.156.60-1000.960
Patients with stoma50
Flatulence49s41.4933.0028.610.20-1000.908
Leakage50 s42.1736.4932.716.30-1000.889
Sore skin around stoma51s42.8538.4934.520.40-1000.965
Bags change52.53 s18.3622.624920-830.969
Embarrassed54s45.5643.0941.829.10-1000.956
Stoma care pb55s40.0841.4746.821.50-1000.912
Stoma pb49-54s37.4120.184.14.10-1000.999
Patients without stoma172
Flatulence4930.6237.0152.912.80-1000.980
Faecal incontinence5026.1637.3861.614.00-1000.970
Sore skin around anus5120.3431.7264.57.60-1000.979
Stool frequency52.5329.6532.3338.47.60-1000.977
Embarrassment5431.2038.5154.715.10-1000.975
Defecation pb49-5428.7925.8416.10.70-1000.969
Male 123
Sexual functioning5642.8537.813320.50-1000.928
Impotence5738.1838.7940.9200-1000.966
Female 98
Sexual functioning 5867.0636.7611.948.80-1000.933
Dyspareunia5926.5835.7558.310.70-1000.985
C30221
Physical function1 - 573.6423.850.923.90-100-
Role function6.762.9237.0013.339.00-100-
Emotional function21-2467.2430.774.130.70-100-
Cognitive function20. 2583.9423.450.558.30-100-
Social function26 . 2779.5828.933.757.30-100-
Fatigue10.12.1830.9829.1727.12.80-100-
Nausea and vomiting14.157.7917.1678.00.50-83-
Pain9.1924.3129.7246.83.70-100-
Dyspnoea821.1030.5962.44.60-100-
Insomnia1127.6735.2556.49.20-100-
Appetite loss1320.4830.9963.36.40-100-
Constipation1627.5233.9753.81.40-100-
Diarrhea1727.6734.6753.210.60-100-
Financial difficulties2851.2240.6130.730.70-100-
Table 3 Convergent and discriminant validity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29
QLQ-CR29 scalesTotal sample (n = 221)
Patients without stoma (n = 50)
Patients with stoma (n = 171)
Convergent
Discriminant
α
Convergent
Discriminant
α
Convergent
Discriminant
α
Urinary frequency0.905-0.907-0.00-0.250.7950.83-0.84-0.00-0.210.660.91-0.92-0.12-0.250.82
Blood or mucus in stool0.74-0.89-0.27-0.350.6150.62-0.96-0.44-0.350.5810.79-0.87-0.20-0.300.65
Body image-0.66-0.75-0.00-0.360.672-0.51-0.89-0.20-0.390.690-0.63-0.72-0.07-0.190.64
Stool frequency0.83-0.96-0.30-0.390.83510.83-0.96-0.31-0.390.804-0.85-0.91-0.14-0.340.87
Table 4 Correlation between the Quality of Life Questionnaire-CR29 and the Quality of Life Questionnaire-C30

EORTC QLQ C30
CR-29Functional scalesSymptom scales
Scales/Single itemsQoLPFRFEFCFSFFANVPADYSLAPCODIFI
Functional scales
Body image0.29420.27920.37020.21420.24420.4032-0.2982-0.2562-0.1611-0.2502-0.1511-0.2782-0.2212-0.003-0.079
Anxiety0.29720.31420.26420.31520.27320.2852-0.2942-0.1601-0.2102-0.1691-0.1381-0.117-0.029-0.008-0.1671
Sexual function: Male-0.121-0.133-0.058-0.011-0.034-0.1110.009-0.0100.0840.0890.1240.1090.0490.0490.018
Sexual function: Female-0.2992-0.192-0.115-0.079-0.25610.0400.082-0.0330.2211-0.0010.23010.0400.0170.1120.033
Symptom scales
Urinary frequency-0.1371-0.2472-0.2012-0.2372-0.0890.0290.24420.0700.21820.23020.17620.16510.0420.22120.122
Blood and mucus in stool-0.2412-0.2832-0.2692-0.1902-0.110-0.1230.35920.21520.34920.19020.27720.26820.15210.30220.2562
Urinary incontinence-0.009-0.128-0.060-0.2372-0.1521-0.0500.1020.0140.1080.15010.19520.0300.13510.0320.044
Dysuria-0.017-0.103-0.1611-0.069-0.065-0.0470.15310.0120.17210.0580.13310.0860.0910.1000.025
Abdominal pain-0.1381-0.1611-0.099-0.125-0.099-0.0550.23220.14310.44320.14010.25420.1220.16810.107-0.039
Buttock pain-0.2122-0.2652-0.2702-0.103-0.098-0.0740.36320.14910.46920.19420.25320.19020.0250.14910.2802
Bloated feeling-0.2062-0.2132-0.1381-0.2132-0.1451-0.0840.29220.17110.37720.25620.38020.0580.25320.0400.073
Dry mouth-0.3092-0.3412-0.2572-0.2662-0.2832-0.1250.34020.39020.20520.20220.14110.32920.21120.14510.113
Hair loss-0.036-0.1952-0.1331-0.3372-0.2422-0.1310.18320.21720.0840.0800.14110.18220.20020.13510.033
Trouble with taste-0.099-0.2472-0.2362-0.1341-0.1731-0.1250.24320.34320.0360.20220.0100.27120.17310.1010.072
Weight0.17620.28020.29120.15710.1210.1792-0.2382-0.128-0.081-0.060-0.1431-0.1651-0.1691-0.083-0.017
Flatulences0.124-0.0230.139-0.126-0.180-0.2600.0770.056-0.0620.2620.0420.0650.1310.1470.117
Leakage0.0830.1420.046-0.271-0.128-0.1460.0330.059-0.0230.114-0.0040.0930.0290.1270.240
Sore skin around stoma-0.041-0.1900.025-0.6002-0.4022-0.33010.29510.2610.29710.2470.38020.0730.1720.0020.133
Bags changes-0.085-0.1690.002-0.4042-0.025-0.2730.228-0.0180.1550.2180.34410.192-0.0030.019-0.098
Embarrassment-0.4072-0.3122-0.3942-0.2721-0.150-0.1640.47620.1550.41920.32520.35320.156-0.0790.0300.3612
Stoma care problems-0.5022-0.3912-0.4582-0.2771-0.182-0.22810.52920.23910.58720.32820.46820.23910.093-0.0640.3432
Stoma problems-0.077-0.142-0.009-0.5802-0.277-0.36410.33610.1080.1810.2640.30110.1380.1040.1790.139
Flatulences-0.1601-0.1511-0.034-0.149-0.137-0.1120.1440.0320.17710.26920.1731-0.0030.0080.25220.2002
Faecal incontinence-0.036-0.081-0.040-0.142-0.122-0.1170.15310.0840.19010.1410.111-0.017-0.1400.40320.2032
Sore skin around anus-0.081-0.012-0.045-0.057-0.047-0.1020.0490.1130.0860.1210.0270.027-0.0060.1490.1951
Stool frequency0.002-0.019-0.024-0.0710.0020.0240.083-0.0440.25920.0920.1230.004-0.0350.45220.1891
Embarrassment-0.101-0.133-0.135-0.2072-0.1671-0.20820.17810.1410.1490.27620.15210.0620.1460.22420.2032
Defecation-0.111-0.116-0.038-0.2021-0.159-0.17310.19010.1570.28020.31620.18110.0400.1060.37920.2902
Impotence0.019-0.065-0.149-0.104-0.170-0.21810.0750.2431-0.1040.31320.0650.30820.1750.0080.064
Dyspareunia-0.083-0.096-0.118-0.174-0.2431-0.34520.1080.0250.26010.1630.1620.1560.0450.1570.2361
Table 5 Known-group comparisons

Stoma status
Colon vs Rectum
Neoadjuvant radiochemotherapy
CR-29 scales/single itemsYes (n = 50)No (n = 171)P valueColon (n = 78)Rectum (n = 139)P valueYes (n = 89)No (n = 107)P value
Urinary frequency35.6 (41.1)41.1 (34.6)0.41235.4 (31.2)42.2 (34.8)0.21545.5 (33.9)35.0 (32.2)0.031
Blood and mucus in stool27.6 (28.8)23.8 (29.1)0.24720.2 (26.8)27.4 (30.2)0.08629.9 (30.3)19.3 (27.1)0.004
Body image66.6 (27.5)81.1 (23.0)0.00077.4 (24.8)77.7 (25.0)0.93877.6 (24.1)78.9 (24.5)0.625
Urinary incontinence24.0 (35.0)20.0 (31.4)0.45118.3 (28.7)21.5 (33.0)0.78820.2 (32.0)21.4 (32.1)0.592
Dysuria21.3 (29.1)20.4 (31.9)0.46918.8 (30.6)22.3 (31.9)0.12023.2 (32.3)18.3 (29.7)0.299
Abdominal pain28.0 (32.5)31.3 (34.6)0.59028.6 (34.2)32.1 (34.3)0.44034.4 (34.6)26.7 (33.4)0.095
Buttock pain28.6 (33.6)26.7 (34.9)0.56317.0 (30.2632.3 (36.1)0.00138.5 (36.2)14.3 (27.5)0.000
Bloated feeling30.6 (33.5)28.2 (33.9)0.54527.7 (32.4)29.0 (34.2)0.89235.2 (35.6)23.6 (31.7)0.017
Dry mouth30.0 (36.4)23.0 (33.4)0.18320.5 (29.0)26.6 (36.5)0.47730.7 (38.3)19.0 (28.9)0.055
Hair loss17.3 (28.7)16.1 (29.1)0.60810.6 (24.9)19.4 (31.5)0.02718.7 (30.1)14.6 (28.6)0.222
Trouble with taste27.3 (36.0)18.5 (31.7)0.06913.2 (27.5)24.4 (35.1)0.01620.5 (31.1)17.7 (31.8)0.375
Anxiety52.6 (40.4)67.8 (36.1)0.01663.2 (37.8)65.4 (37.0)0.65865.9 (36.5)63.5 (38.4)0.725
Weight69.3 (38.6)77.3 (30.6)0.30579.4 (30.4)73.8 (33.2)0.19475.6 (30.4)76.3 (33.9)0.492
Flatulence45.8 (31.9)39.3 (32.7)0.60135.0 (34.1)45.6 (33.7)0.361
Leakage45.8 (31.9)40.4 (38.8)0.55842.1 (39.8)45.6 (31.8)0.705
Sore skin around stoma39.5 (32.7)44.4 (41.3)0.74850.8 (43.5)43.8 (33.4)0.598
Bags changes21.8 (27.0)16.6 (20.4)0.58417.5 (19.6)26.3 (27.3)0.351
Embarrassment64.5 (28.46)40.7 (44.9)0.05656.3 (46.3)36.9 (39.8)0.055
Stoma care problems37.5 (38.2)40.7 (42.5)0.80454.0 (42.1)23.4 (36.7)0.003
Stoma problems39.9 (17.1)36.1 (21.6)0.49937.1 (23.4)41.8 (16.4)0.387
Flatulences21.5 (33.6)34.5 (37.3)0.01743.8 (39.1)19.6 (31.8)0.000
Faecal incontinence16.12 (30.6)31.4 (39.5)0.00935.7 (41.0)17.0 (31.5)0.001
Sore skin around anus11.8 (24.2)25.1 (34.6)0.01229.5 (36.1)13.6 (26.0)0.002
Stool frequency19.3 (26.8)35.8 (34.2)0.00237.6 (36.1)21.5 (26.8)0.008
Embarrassment23.1 (35.4)34.9 (39.1)0.05340.4 (39.2)23.4 (35.7)0.004
Defecation pb18.8 (21.5)36.5 (36.5)0.00037.8 (27.4)19.5 (21.0)0.000
(F) Sexual function: Male54.1 (39.1)39.7 (37.1)0.16232.4 (32.4)48.1 (39.4)0.04746.3 (39.4)36.0 (32.8)0.211
Impotence47.2 (39.2)35.6 (38.5)0.02131.5 (34.6)41.6 (40.6)0.24843.9 (39.2)33.3 (36.8)0.167
Sexual function: Female56.8 (38.6)69.6 (36.1)0.06465.4 (33.3)66.6 (39.6)0.77069.4 (35.9)70.0 (35.2)0.928
Dyspareunia33.3 (39.1)24.8 (34.9)0.15620.23 (33.1)29.4 (37.1)0.24026.8 (32.6)23.3 (35.5)0.459
Table 6 Known-group comparisons, P < 0.0001

Gender
Age
CR-29 scales/single ItemsMale (n = 123)Female (n = 98)P value≤ 40 (n = 26)41-65 (n = 144)≥ 66 (n = 45)P value
Urinary frequency39.7 (33.1)40.1 (34.1)0.86228.2 (30.4)42.4 (33.3)38.1 (34.1)0.115
Blood and mucus in stool24.6 (27.8)24.8 (30.5)0.79425.6 (29.5)26.7 (29.4)19.2 (27.5)0.183
Body image77.4 (25.0)78.3 (24.7)0.77774.3 (23.2)76.6 (26.1)80.7 (21.8)0.481
Urinary incontinence19.5 (31.9)22.7 (32.6)0.38519.2 (28.5)19.6 (32.3)26.6 (33.0)0.273
Dysuria23.3 (32.2)17.3 (29.9)0.10123.0 (36.2)20.8 (31.5)20.7 (29.5)0.978
Abdominal pain27.6 (33.5)34.3 (34.6)0.17232.0 (34.6)31.9 (35.2)26.6 (29.8)0.772
Buttock pain28.1 (34.9)25.8 (34.3)0.47832.0 (34.6)27.7 (36.1)22.2 (30.1)0.500
Bloated feeling27.3 (32.8)30.6 (35.0)0.49526.9 (32.6)31.9 (35.0)22.9 (30.8)0.293
Dry mouth17.3 (28.7)33.6 (38.1)0.00123.0 (33.6)24.7 (33.8)25.1 (36.3)0.967
Hair loss8.6 (21.7)26.2 (34.9)0.00012.8 (28.4)19.6 (32.3)10.3 (19.8)0.228
Trouble with taste16.8 (31.4)25.1 (34.2)0.04030.7 (38.7)20.6 (33.4)14.8 (27.1)0.282
Anxiety69.6 (34.9)57.8 (39.9)0.03265.3 (38.2)60.1 (38.2)73.3 (34.5)0.116
Weight75.3 (33.3)75.8 (32.0)0.92075.6 (30.6)74.5 (33.6)77.0 (31.6)0.933
Flatulence43.6 (32.2)38.3 (34.6)0.56638.8 (32.7)44.7 (33.2)33.3 (36.5)0.667
Leakage47.1 (36.2)35.0 (36.6)0.24161.1 (44.3)41.9 (34.6)27.7 (38.9)0.299
Sore skin around stoma44.8 (39.1)40.0 (38.3)0.65066.6 (42.1)42.8 (37.5)33.3 (36.5)0.287
Bags changes20.1 (22.4)15.8 (23.2)0.42722.2 (25.0)20.9 (23.6)5.5 (8.6)0.328
Embarrassment46.3 (42.4)44.4 (44.6)0.68051.8 (50.3)51.3 (41.8)31.4 (40.3)0.230
Stoma care problems42.7 (43.1)36.3 (39.4)0.48166.6 (50.0)40.9 (40.2)29.6 (37.7)0.093
Stoma problems39.8 (20.0)33.8 (20.3)0.33648.1 (31.7)38.8 (16.9)23.1 (20.9)0.183
Flatulences29.0 (38.5)32.4 (35.2)0.45236.6 (41.7)33.6 (37.8)20.5 (31.1)0.142
Faecal incontinence23.4 (35.8)29.4 (39.1)0.39140.0 (44.0)28.7 (38.3)14.5 (28.4)0.050
Sore skin around anus17.3 (29.6)23.9 (33.9)0.30026.6 (36.8)21.7 (32.8)12.8 (24.9)0.266
Stool frequency27.8 (30.2)31.8 (34.7)0.83635.8 (34.7)33.0 (33.7)18.3 (25.0)0.029
Embarrassment27.3 (36.5)35.8 (40.4)0.17941.6 (38.8)36.0 (40.8)14.5 (26.2)0.005
Defecation pb26.9 (25.3)30.9 (26.4)0.49937.5 (33.0)30.3 (25.5)17.5 (19.0)0.032
Sexual function: Male33.3 (36.9)42.7 (37.8)45.8 (36.5)0.575
Impotence48.7 (44.3)35.2 (38.5)42.0 (35.1)0.465
Sexual function: Female57.5 (36.7)63.5 (37.7)82.3 (31.4)0.109
Dyspareunia33.3 (36.5)27.6 (36.8)9.8 (22.8)0.098