Journal List > J Korean Acad Nurs > v.44(6) > 1003039

Kim, Kang, Youn, So, Song, Chae, Jung, Kim, and Kim: Reliability and Validity of the Korean Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to Assess Chemotherapy-induced Peripheral Neuropathy

Abstract

Purpose

This study was performed to assess the reliability and validity of the Korean version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-induced peripheral neuropathy 20 items (EORTC QLQ-CIPN20) in patients receiving neurotoxic chemotherapy.

Methods

A convenience sample of 249 Korean cancer patients, previously or currently, being treated with peripheral neurotoxic chemotherapeutic agents were asked to fill in the questionnaire. Collected data were analyzed using SPSS 21.0 and AMOS 21.0. Construct validity, known-group validity, concurrent validity, and internal consistency reliability of the Korean version of the QLQ-CIPN20 were evaluated.

Results

Factor analysis confirmed 3 dimensions of CIPN: sensory, motor, and autonomic. The factor loadings of the 20 items on the 3 subscales ranged from .38 to .85. The 3 subscale-model was validated by confirmatory factor analysis (GFI= .90, AGFI= .86, RMSR= .05, NFI= .87, and CFI= .94), and concurrent validity was demonstrated with the EORTC QLQ-C30. Furthermore, the QLQ-CIPN20 established known-group validity. The Cronbach's alpha coefficients for internal consistency of the subscales ranged from .73 to .89.

Conclusion

The Korean version of the EORTC QLQ-CIPN20 showed satisfactory construct, concurrent, and known-group validity, as well as internal reliability.

References

1. Azhary H, Farooq MU, Bhanushali M, Majid A, Kassab MY. Peripheral neuropathy: Differential diagnosis and management. American Family Physician. 2010; 81(7):887–892.
2. Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, et al. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: The QLQ-CIPN20. European Journal of Cancer. 2005; 41(8):1135–1139. http://dx.doi.org/10.1016/j.ejca.2005.02.012.
crossref
3. Dunlap B, Paice JA. Chemotherapy-induced peripheral neuropathy: A need for standardization in measurement. The Journal of Supportive Oncology. 2006; 4(8):398–399.
4. Delforge M, Bladé J, Dimopoulos MA, Facon T, Kropff M, Ludwig H, et al. Treatment-related peripheral neuropathy in multiple myeloma: The challenge continues. Lancet Oncology. 2010; 11(11):1086–1095. http://dx.doi.org/10.1016/s1470-2045(10)70068-1.
crossref
5. Kautio AL, Haanpää M, Kautiainen H, Kalso E, Saarto T. Burden of chemotherapy-induced neuropathy-a cross-sectional study. Supportive Care in Cancer. 2011; 19(12):1991–1996. http://dx.doi.org/10.1007/s00520-010-1043-2.
crossref
6. Kiser DW, Greer TB, Wilmoth MC, Dmochowski J, Naumann RW. Peripheral neuropathy in patients with gynecologic cancer receiving chemotherapy: Patient reports and provider assessments. Oncology Nursing Forum. 2010; 37(6):758–764. http://dx.doi.org/10.1188/10.onf.758-764.
crossref
7. Tofthagen C, McAllister RD, McMillan SC. Peripheral neuropathy in patients with colorectal cancer receiving oxaliplatin. Clinical Journal of Oncology Nursing. 2011; 15(2):182–188. http://dx.doi.org/10.1188/11.cjon.182-188.
crossref
8. Visovsky C, Collins M, Abbott L, Aschenbrenner J, Hart C. Putting evidence into practice: Evidence-based interventions for chemotherapy-induced peripheral neuropathy. Clinical Journal of Oncology Nursing. 2007; 11(6):901–913. http://dx.doi.org/10.1188/07.cjon.901-913.
crossref
9. Richardson PG, Briemberg H, Jagannath S, Wen PY, Barlogie B, Beren-son J, et al. Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. Journal of Clinical Oncology. 2006; 24(19):3113–3120. http://dx.doi.org/10.1200/jco.2005.04.7779.
crossref
10. Griffith KA, Merkies IS, Hill EE, Cornblath DR. Measures of chemotherapy-induced peripheral neuropathy: A systematic review of psychometric properties. Journal of the Peripheral Nervous System. 2010; 15(4):314–325. http://dx.doi.org/10.1111/j.1529-8027.2010.00292.x.
crossref
11. Postma TJ, Heimans JJ. Grading of chemotherapy-induced peripheral neuropathy. Annals of Oncology. 2000; 11(5):509–513.
crossref
12. Wickham R. Chemotherapy-induced peripheral neuropathy: A review and implications for oncology nursing practice. Clinical Journal of Oncology Nursing. 2007; 11(3):361–376. http://dx.doi.org/10.1188/07.cjon.361-376.
crossref
13. Cavaletti G, Cornblath DR, Merkies IS, Postma TJ, Rossi E, Frigeni B, et al. The chemotherapy-induced peripheral neuropathy outcome measures standardization study: From consensus to the first validity and reliability findings. Annals of Oncology. 2013; 24(2):454–462. http://dx.doi.org/10.1093/annonc/mds329.
crossref
14. Barton DL, Wos EJ, Qin R, Mattar BI, Green NB, Lanier KS, et al. A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Supportive Care in Cancer. 2011; 19(6):833–841. http://dx.doi.org/10.1007/s00520-010-0911-0.
crossref
15. Kim HY, Kang JH, Song CE, Youn HJ. Chemotherapy-induced peripheral neuropathy and quality of life in breast cancer patients. Asian Oncology Nursing. 2013; 13(4):222–230. http://dx.doi.org/10.5388/aon.2013.13.4.222.
crossref
16. Mols F, Beijers T, Lemmens V, van den Hurk CJ, Vreugdenhil G, van de Poll-Franse LV. Chemotherapy-induced neuropathy and its association with quality of life among 2- to 11-year colorectal cancer survivors: results from the population-based PROFILES registry. Journal of Clinical Oncology. 2013; 31(21):2699–2707. http://dx.doi.org/10.1200/jco.2013.49.1514.
crossref
17. Kim JH, Choi KS, Kim TW, Hong YS. Quality of life in colorectal cancer patients with chemotherapy-induced peripheral neuropathy. Journal of Korean Oncology Nursing. 2011; 11(3):254–262. http://dx.doi.org/10.5388/jkon.2011.11.3.254.
crossref
18. Kwak MK, Kim EJ, Lee ER, Kwon IG, Hwang MS. Characteristics and quality of life in patients with chemotherapy-induced peripheral neuropathy. Journal of Korean Oncology Nursing. 2010; 10(2):231–239. http://dx.doi.org/10.5388/jkon.2010.10.2.231.
crossref
19. Dewolf L, Koller M, Velikova G, Johnson C, Scott N, Bottomley A. EORTC quality of life group translation procedure. 3rd ed. Brussels, BE: EORTC Quality of Life Group;2009.
20. Tabachnick BG, Fidell LS. Using multivariate statistics. 3rd ed. New York, NY: Harper Collins Publishers;1996.
21. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A. The EORTC QLQ-C30 scoring manual. 3rd ed. Brussels, BE: EORTC Quality of Life Group;2001.
22. Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, et al. Validation of the Korean version of the EORTC QLQ-C30. Quality of Life Research. 2004; 13(4):863–868.
crossref
23. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute. 1993; 85(5):365–376.
crossref
24. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the eastern cooperative oncology group. American Journal of Clinical Oncology. 1982; 5(6):649–655.
crossref
25. Kim GS. Analysis structural equation modeling. Seoul: Hannarae Publishing Co.;2007.
26. Nunnally JC, Bernstein IH. Psychometric theory. 3rd ed. New York, NY: McGraw-Hill;1994.
27. Kim EJ. Accessing factor structure and construct validity of the successful aging inventory. Journal of Korean Academy of Nursing. 2013; 43(4):568–578. http://dx.doi.org/10.4040/jkan.2013.43.4.568.
crossref
28. Park HA. Problems and issues in developing measurement scales in nursing. Journal of Nursing Query. 2005; 14(1):46–72.
29. Kim SH, Jo MW, Lee SI. Psychometric properties of the Korean short form-36 health survey version 2 for assessing the general population. Asian Nursing Research. 2013; 7(2):61–66.
30. Lee EH, Moon S, Cho SY, Oh YT, Chun M, Kim SH, et al. Psychometric evaluation of a need scale for cancer patients undergoing follow-up care. Journal of Korean Academy of Nursing. 2010; 40(4):551–560. http://dx.doi.org/10.4040/jkan.2010.40.4.551.
crossref

Table 1.
General and Clinical Characteristics (N=249)
Characteristics Categories n (%) M±SD
Age (year) <49 50 (20.1) 59.92±11.62
50-59 84 (33.7)
60-69 61 (24.5)
≥70 54 (21.7)
Gender Female 136 (54.6)
Male 113 (45.4)
Occupation Employed 57 (22.9)
Unemployed 192 (77.1)
Education Under or equal to elementary school graduate 62 (24.9)
Middle school graduate 41 (16.4)
High school graduate 101 (40.6)
Over or equal to college graduate 45 (18.1)
Type of cancer Breast cancer 82 (32.9)
Colon & rectal cancer 51 (20.5)
Gastric cancer 24 (9.6)
Esophageal cancer 4 (1.6)
Bile duct cancer 5 (2.8)
Ovarian cancer 4 (1.6)
Lung cancer 3 (1.2)
Malignant lymphoma 31 (12.4)
Multiple myeloma 32 (12.9)
Leukemia 8 (3.2)
Others 5 (1.3)
Time since diagnosis (month) <5 35 (14.0)
5-12 65 (26.1)
13-24 48 (19.3)
25-36 37 (14.9)
37-48 18 (7.2)
≥49 46 (18.5)
Stage (n=178) Stage 2 22 (12.4)
Stage 3 52 (29.2)
Stage 4 104 (58.4)
Current chemotherapy Yes 169 (67.9)
No 80 (32.1)
Duration of CIPN (month) <5 73 (29.3)
5-12 68 (27.3)
13-24 48 (19.3)
≥25 60 (24.1)
ECOG PS 0 71 (28.5)
1 151 (60.6)
2 27 (10.9)

CIPN=Chemotherapy-induced peripheral neuropathy; ECOG PS=Eastern Cooperative Oncology Group performance status.

Table 2.
Construct Validity and Reliability
Constructs Items Factor loading Error estimate CR AVE Inter-subscale correlation Cronbach’s alpha
Sensory Did you have tingling fingers or hands? .62 .46 .90 .50 .42~.53* .89
Did you have tingling toes or feet? .70 .43
Did you have numbness in your fingers or hands? .68 .44
Did you have numbness in your toes or feet? .72 .38
Did you have shooting or burning pain in your fingers or hands? .66 .44
Did you have shooting or burning pain in your toes or feet? .67 .45
Did you have problems standing or walking because of difficulty feeling the ground under your feet? .85 .29
Did you have difficulty distinguishing between hot and cold water? .54 .55
Did you have difficulty hearing? .54 .55
Motor Did you have cramps in your hands? Did you have cramps in your feet? .38 .70 .78 .50 .89 .52 .53~.54* .88
Did you have a problem holding a pen, which made writing difficult? .80 .38
Did you have difficulty manipulating small objects with your fingers (for example, fastening small buttons)? .71 .40
Did you have difficulty opening a jar or bottle because of weakness in your hands? .83 .30
Did you have difficulty walking because your feet dropped downwards? .67 .47
Did you have difficulty climbing stairs or getting up out of a chair because of weakness in your legs? .68 .49
If you drive a car, did you have difficulty using the pedals? .66 .44
Autonomic Were you dizzy when standing up from a sitting or lying position? .83 .30 .74 .60 .42~.54* .73
Did you have blurred vision? .78 .39
If you are a man, did you have difficulty getting or maintaining an erection? .39 .75

* p<.001; CR=Composite reliability; AVE=Average variance extracted.

Table 3.
Model Fit Test
Model Items Absolute fit index
Incremental fit index
χ2 (p) χ2/df GFI AGFI RMSR NFI CFI
Model 1 20 231.89 (<.001) 1.58 .90 .86 .05 .87 .94
Model 2 18 209.66 (<.001) 1.58 .91 .87 .05 .87 .95

GFI=Goodness of fit index; AGFI=Adjusted goodness of fit index; RMSR=Root mean square residual; NFI=Normal fit index; CFI=Comparative fit index.

Table 4.
Correlations between the QLQ-C30 and QLQ-CIPN20 for Concurrent Validity
QLQ-C30 QLQ-CIPN20
Sensory
Motor
Autonomic
r (p) r (p) r (p)
Global health status −.32 (<.001) −.28 (<.001) −.30 (<.001)
Functional −.51 (<.001) −.58 (<.001) −.60 (<.001)
Symptom .49 (<.001) .51 (<.001) .57 (<.001)

QLQ-C30=Cancer Core Quality of Life Questionnaire 30 items; QLQ-CIPN20=Quality of life questionnaire chemotherapy-induced peripheral neuropathy 20 items.

Table 5.
Known-group Validity Tests
ECOG PS QLQ-CIPN20
Sensory
Motor
Autonomic
M±SD F (p) M±SD F (p) M±SD F (p)
0 15.39±16.12 13.28 (<.001) 14.92±16.51 12.62 (<.001) 30.97±19.51 10.34 (<.001)
1 28.73±19.57 26.72±19.48 37.18±20.35
2 39.23±19.85 37.45±17.37 55.00±22.78

ECOG PS=Eastern Cooperative Oncology Group performance status; QLQ-CIPN20=Quality of life questionnaire chemotherapy-induced peripheral neuropathy 20 items.

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