Cancer Res Treat.  2021 Jul;53(3):763-772. 10.4143/crt.2020.1270.

Development and Validation of a Symptom-Focused Quality of Life Questionnaire (KOQUSS-40) for Gastric Cancer Patients after Gastrectomy

• Eom BW
• Lee J
• Lee IS
• Son YG
• Ryu KW
• Kim SG
• Kim HI
• Kim YW
• Kong SH
• Kwon OK
• Park JH
• An JY
• Kim CH
• Suh BJ
• Yoon HM
• Son MW
• Park JY
• Park JM
• Jeong SH
• Yoo MW
• Song GJ
• Yang HK
• Suh YS
• Park KB
• Ahn SH
• Shin DW
• Jee YS
• Ahn HS
• Lee S
• Min JS
• In H
• Kim A
• Hur H
• Lee HJ
• on behalf of KOrean QUality of life in Stomach cancer patients Study group (KOQUSS)

• KMID: 2518400
• DOI: http://doi.org/10.4143/crt.2020.1270

Abstract

Purpose
Patients who have undergone gastrectomy have unique symptoms that are not appropriately assessed using currently available tools. This study developed and validated a symptom-focused quality of life (QoL) questionnaire for patients who have received gastrectomy for gastric cancer. Materials and Methods Based on a literature review, patient interviews, and expert consultation by the KOrean QUality of life in Stomach cancer patients Study group (KOQUSS), the initial item pool was developed. Two large-scale developmental studies were then sequentially conducted for exploratory factor analyses for content validity and item reduction. The final item pool was validated in a separate cohort of patients and assessed for internal consistency, test-retest reliability, construct validity, and clinical validity.
Results
The initial questionnaire consisted of 46-items in 12 domains. Data from 465 patients at 11 institutions, followed by 499 patients at 13 institutions, were used to conduct item reduction and exploratory factor analyses. The final questionnaire (KOQUSS-40) comprised 40 items within 11 domains. Validation of KOQUSS-40 was conducted on 413 patients from 12 hospitals. KOQUSS-40 was found to have good model fit. The mean summary score of the KOQUSS-40 was correlated with the EORTC QLQ-C30 and STO22 (correlation coefficients, 0.821 and 0.778, respectively). The KOQUSS-40 score was also correlated with clinical factors, and had acceptable internal consistency (> 0.7). Test-retest reliability was greater than 0.8. Conclusion The KOQUSS-40 can be used to assess QoL of gastric cancer patients after gastrectomy and allows for a robust comparison of surgical techniques in clinical trials.

Keyword

Stomach neoplasms; Quality of life; Surveys and questionnaires; Validation study

Figure

• 

  Fig. 1 Study flowchart.

Reference

References

1. Information Committee of Korean Gastric Cancer Association. Korean Gastric Cancer Association Nationwide Survey on Gastric Cancer in 2014. J Gastric Cancer. 2016; 16:131–40.

2. Samm N, Han WH, Yoon HM, Ryu KW, Cho H, Lee S, et al. Prognostic implications of the eighth edition of the union for international cancer control - classification for gastric cancer patients from specialized treatment centers in Germany and Korea: a STOBE-Compliant large-scale cohort study. Medicine (Baltimore). 2020; 99:e18922.

3. Sprangers MA, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European Organization for Research and Treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on Quality of Life. Qual Life Res. 1993; 2:287–95.

4. Eremenco SL, Cashy J, Webster K, Ohashi Y, Locker GY, Pelletier G, et al. FACT-Gastric: a new international measure of QOL in gastric cancer. J Clin Oncol. 2004; 22(14 Suppl):8123.

5. Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, et al. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg. 2008; 248:721–7.

6. Park JY, Kim YW, Ryu KW, Nam BH, Lee YJ, Jeong SH, et al. Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer: a multicenter randomized phase III clinical trial (SENORITA trial) protocol. BMC Cancer. 2016; 16:340.

7. Kim SM, Cho J, Kang D, Oh SJ, Kim AR, Sohn TS, et al. A randomized controlled trial of vagus nerve-preserving distal gastrectomy versus conventional distal gastrectomy for postoperative quality of life in early stage gastric cancer patients. Ann Surg. 2016; 263:1079–84.

8. Lee JH, Lee HJ, Choi YS, Kim TH, Huh YJ, Suh YS, et al. Postoperative quality of life after total gastrectomy compared with partial gastrectomy: longitudinal evaluation by European Organization for Research and Treatment of Cancer-OG25 and STO22. J Gastric Cancer. 2016; 16:230–9.

9. Nakada K, Ikeda M, Takahashi M, Kinami S, Yoshida M, Uenosono Y, et al. Characteristics and clinical relevance of postgastrectomy syndrome assessment scale (PGSAS)-45: newly developed integrated questionnaires for assessment of living status and quality of life in postgastrectomy patients. Gastric Cancer. 2015; 18:147–58.

10. Brierley JD, Gospodarowicz MK, Wittekind C. TNM classification of malignant tumours. 8th ed. Chichester: Wiley-Blackwell;2017.

11. Guideline Committee of the Korean Gastric Cancer Association (KGCA), Development Working Group & Review Panel. Korean practice guideline for gastric cancer 2018: an evidence-based, multi-disciplinary approach. J Gastric Cancer. 2019; 19:1–48.

12. Japanese Gastric Cancer Associaion. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017; 20:1–19.

13. Ajani JA, Bentrem DJ, Besh S, D’Amico TA, Das P, Denlinger C, et al. Gastric cancer, version 2.2013: featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2013; 11:531–46.

14. Hopkins WG. Measures of reliability in sports medicine and science. Sports Med. 2000; 30:1–15.

15. Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. 3rd ed. Oxford;Oxford University Press;2003.

16. EORTC Data Center. EORTC QLQ-C30 scoring manual [Inter-net]. Brussels: EORTC;c2001. [cited 2020 Dec 28]. Available from: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf .

17. Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW, et al. Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol. 2016; 69:79–88.

18. Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. 2nd ed. Oxford: Oxford Medical Publications;1995.

19. Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, et al. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004; 13:863–8.

20. Bae JM, Kim S, Kim YW, Ryu KW, Lee JH, Noh JH, et al. Health-related quality of life among disease-free stomach cancer survivors in Korea. Qual Life Res. 2006; 15:1587–96.

21. Pompili C, Koller M, Velikova G, Franks K, Absolom K, Callister M, et al. EORTC QLQ-C30 summary score reliably detects changes in QoL three months after anatomic lung resection for Non-Small Cell Lung Cancer (NSCLC). Lung Cancer. 2018; 123:149–54.

22. Takahashi M, Terashima M, Kawahira H, Nagai E, Uenosono Y, Kinami S, et al. Quality of life after total vs distal gastrectomy with Roux-en-Y reconstruction: use of the Postgastrectomy Syndrome Assessment Scale-45. World J Gastroenterol. 2017; 23:2068–76.

23. Fujita J, Takahashi M, Urushihara T, Tanabe K, Kodera Y, Yumiba T, et al. Assessment of postoperative quality of life following pylorus-preserving gastrectomy and Billroth-I distal gastrectomy in gastric cancer patients: results of the nationwide postgastrectomy syndrome assessment study. Gastric Cancer. 2016; 19:302–11.

24. Nishigori T, Okabe H, Tsunoda S, Shinohara H, Obama K, Hosogi H, et al. Superiority of laparoscopic proximal gastrectomy with hand-sewn esophagogastrostomy over total gastrectomy in improving postoperative body weight loss and quality of life. Surg Endosc. 2017; 31:3664–72.

25. Lee SS, Ryu SW, Kim IH, Sohn SS. Quality of life beyond the early postoperative period after laparoscopy-assisted distal gastrectomy: the level of patient expectation as the essence of quality of life. Gastric Cancer. 2012; 15:299–304.

26. Woo J, Lee JH, Shim KN, Jung HK, Lee HM, Lee HK. Does the difference of invasiveness between totally laparoscopic distal gastrectomy and laparoscopy-assisted distal gastrectomy lead to a difference in early surgical outcomes? A prospective randomized trial. Ann Surg Oncol. 2015; 22:1836–43.

27. Hinz A, Einenkel J, Briest S, Stolzenburg JU, Papsdorf K, Singer S. Is it useful to calculate sum scores of the quality of life questionnaire EORTC QLQ-C30? Eur J Cancer Care (Engl). 2012; 21:677–83.