Skip to main content
SpringerLink
Log in

Validity of the Japanese version of functional assessment of cancer therapy-gastric (FACT-Ga) and its sensitivity to ascites volume change: a retrospective analysis of Japanese clinical trial participants

  • Original Article
  • Published:
Supportive Care in Cancer Aims and scope Submit manuscript

Abstract

Purpose

The functional assessment of cancer therapy-gastric (FACT-Ga) questionnaire was designed to evaluate quality of life (QOL) in patients with gastric cancer. We aimed to explore the reliability and validity of FACT-Ga in Japanese patients, and assess the sensitivity of the gastric cancer subscale for detecting changes in cancer-related variables over time.

Methods

The Japanese version of FACT-Ga was used, and data were obtained from Japanese patients who participated in either of two clinical trials: treatment for advanced or recurrent gastric cancer with ascites (advanced-GC group), or adjuvant chemotherapy after curative resection of gastric cancer (adjuvant group). Psychometric data including data used to determine reliability, internal consistency, and clinical validity were analyzed. Clinical validity was evaluated by comparing subscale scores for patients in the two groups, and by comparing subscale scores for patients with different performance status scores. Correlation between gastric cancer subscale scores and gastric cancer-related variables was also examined. In addition, sensitivity of the gastric cancer subscale to changes in ascites volume, abdominal girth, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) was examined by evaluating their correlation in the advanced-GC group.

Results

We collected data on 156 patients (62 advanced-GC group patients and 94 adjuvant group patients). Response rates for the subscales were over 80 % at most time points for both the groups. Cronbach’s coefficient alpha revealed good internal consistency for each subscale. At baseline, the adjuvant group had higher QOL scores than the advanced-GC group (P < 0.05), and QOL scores for patients with different performance status scores differed significantly. Changes in gastric cancer subscale scores showed statistically significant correlation with changes in ascites volume (Spearman’s rank correlation coefficient, 0.5; P < 0.05).

Conclusions

FACT-Ga is reliable and clinically valid for Japanese patients with gastric cancer. Detection of QOL changes that correlate with ascites volume changes suggests that it could be used more broadly; FACT-Ga scores could be used as an endpoint for patients with gastric cancer-related ascites.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Quinten C, Coens C, Mauer M, Comte S, Sprangers MA, Cleeland C, et al. (2009) Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol 10(9):865–871

    Article  PubMed  Google Scholar 

  2. Shan B, Shan L, Morris D, Golani S, Saxena A (2015) Systematic review on quality of life outcomes after gastrectomy for gastric carcinoma. J Gastrointest Oncol 6(5):544–560

    PubMed  PubMed Central  Google Scholar 

  3. Morita S, Kaptein AA, Tsuburaya A, Kodera Y, Matsui T, Sakamoto J (2006) Assessment and data analysis of health-related quality of life in clinical trials for gastric cancer treatments. Gastric Cancer 9(4):254–261

    Article  PubMed  Google Scholar 

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

    Google Scholar 

  5. Webster K, Cella D, Yost K (2003) The functional assessment of chronic illness therapy (FACIT) measurement system: properties, applications, and interpretation. Health Qual Life Outcomes 16:79

    Article  Google Scholar 

  6. Eremenco SL, Cella D, Arnold BJ (2005) A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval Health Prof 28(2):212–232

    Article  PubMed  Google Scholar 

  7. Garland SN, Pelletier G, Lawe A, Biagioni BJ, Easaw J, Eliasziw M, et al. (2011) Prospective evaluation of the reliability, validity, and minimally important difference of the functional assessment of cancer therapy-gastric (FACT-Ga) quality-of-life instrument. Cancer 117(6):1302–1312

    Article  PubMed  Google Scholar 

  8. Debb SM, Arnold B, Perez B, Cella D (2011) Validation of the FACT-gastric cancer quality of life questionnaire for use in Spanish-speaking countries. Psychooncology 20(1):19–27

    Article  PubMed  Google Scholar 

  9. Zhou HJ, So JB, Yong WP, Luo N, Zhu F, Naidoo N, et al. (2012) Validation of the functional assessment of cancer therapy-gastric module for the Chinese population. Health Qual Life Outcomes 10:145

    Article  PubMed  PubMed Central  Google Scholar 

  10. Sakamoto J, Morita S, Yumiba T, Narahara H, Kinoshita K, Nakane Y, et al. (2003) A phase II clinical trial to evaluate the effect of paclitaxel in patients with ascites caused by advanced or recurrent gastric carcinoma: a new concept of clinical benefit response for non-measurable type of gastric cancer. Jpn J Clin Oncol 33(5):238–240

    Article  CAS  PubMed  Google Scholar 

  11. Imamoto H, Oba K, Sakamoto J, Iishi H, Narahara H, Yumiba T, et al. (2011) Assessing clinical benefit response in the treatment of gastric malignant ascites with non-measurable lesions: a multicenter phase II trial of paclitaxel for malignant ascites secondary to advanced/recurrent gastric cancer. Gastric Cancer 14(1):81–90

    Article  CAS  PubMed  Google Scholar 

  12. Oriuchi N, Nakajima T, Mochiki E, Takeyoshi I, Kanuma T, Endo K, et al. (2005) A new, accurate and conventional five-point method for quantitative evaluation of ascites using plain computed tomography in cancer patients. Jpn J Clin Oncol 35(7):386–390

    Article  PubMed  Google Scholar 

  13. Tsuburaya A, Sakamoto J, Morita S, Kodera Y, Kobayashi M, Miyashita Y, et al. (2005) A randomized phase III trial of post-operative adjuvant oral fluoropyrimidine versus sequential paclitaxel/oral fluoropyrimidine; and UFT versus S1 for T3/T4 gastriccarcinoma: the Stomach Cancer Adjuvant Multi-institutional Trial Group (Samit) Trial. Jpn J Clin Oncol 35(11):672–675

    Article  PubMed  Google Scholar 

  14. Tsuburaya A, Yoshida K, Kobayashi M, Yoshino S, Takahashi M, Takiguchi N, et al. (2014) Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 versus UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): a phase 3 factorial randomised controlled trial. Lancet Oncol 15(8):886–893

    Article  CAS  PubMed  Google Scholar 

  15. Streiner DL (2003) Starting at the beginning: an introduction to coefficient alpha and internal consistency. J Pers Assess 80(1):99–103

    Article  PubMed  Google Scholar 

  16. Global Burden of Disease Cancer Collaboration, Fitzmaurice C, Dicker D, Pain A, Hamavid H, Moradi-Lakeh M, MacIntyre MF, et al. (2015) The global burden of cancer 2013. JAMA Oncol 1(4):505–527

    Article  PubMed Central  Google Scholar 

  17. Nakajima T, Nishi M, Kajitani T (1991) Improvement in treatment results of gastric cancer with surgery and chemotherapy: experience of 9,700 cases in the Cancer Institute Hospital, Tokyo. Semin Surg Oncol 7(6):365–372

    Article  CAS  PubMed  Google Scholar 

  18. Shan B, Shan L, Morris D, Golani S, Saxena A (2010) Systematic review on quality of life outcomes after gastrectomy for gastric carcinoma. J Gastrointest Oncol 6(5):544–560

    Google Scholar 

  19. Japanese Gastric Cancer Association (2011) Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer 14(2):113–123

    Article  Google Scholar 

  20. Maeda H, Kobayashi M, Sakamoto J (2015) Evaluation and treatment of malignant ascites secondary to gastric cancer. World J Gastroenterol 21(39):10936–10947

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Bodoky G, Scheulen ME, Rivera F, Jassem J, Carrato A, Moiseyenko V, et al. (2015) Clinical benefit and health-related quality of life assessment in patients treated with cisplatin/S-1 versus cisplatin/5-FU: secondary end point results from the First-Line Advanced Gastric Cancer Study (FLAGS). J Gastrointest Cancer 46(2):109–117

    Article  CAS  PubMed  Google Scholar 

  22. Munene G, Francis W, Garland SN, Pelletier G, Mack LA, Bathe OF (2012) The quality of life trajectory of resected gastric cancer. J Surg Oncol 105(4):337–341

    Article  PubMed  Google Scholar 

  23. Levine MN, Ganz PA (2002) Beyond the development of quality-of-life instruments: where do we go from here? J Clin Oncol 20(9):2215–2216

    PubMed  Google Scholar 

  24. Cheung YB, Daniel R, Ng GY (2006) Response and non-response to a quality-of-life question on sexual life: a case study of the simple mean imputation method. Qual Life Res 15(9):1493–1501

    Article  PubMed  Google Scholar 

Download references

Acknowledgment

The part of this study was presented in 2016 ESMO World Congress on Gastrointestinal Cancer held on 29 June–2 July, in Barcelona, Spain.

Author information

Authors and Affiliations

  1. Cancer Treatment Center, Kochi Medical School Hospital, Kochi University, Kohasu, Oko-cho, Nankoku, Kochi, 783-8505, Japan

    Hiromichi Maeda & Michiya Kobayashi

  2. Department of Biostatistics, Graduate School of Medicine, Yokohama City University, Yokohama, Japan

    Maho Sato

  3. Division of Gastroenterological Surgery, Chiba Cancer Center, Chiba, Japan

    Nobuhiro Takiguchi

  4. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan

    Takaki Yoshikawa

  5. Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine, Ube, Japan

    Shigefumi Yoshino

  6. Department of Surgical Oncology, Gifu University, Gifu, Japan

    Kazuhiro Yoshida

  7. Yokohama City University, Yokohama, Japan

    Akira Tsuburaya

  8. Tokai Central Hospital, Kakamigahara, Japan

    Junichi Sakamoto

  9. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan

    Satoshi Morita

Authors
  1. Hiromichi Maeda
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Maho Sato
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Michiya Kobayashi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Nobuhiro Takiguchi
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Takaki Yoshikawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Shigefumi Yoshino
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Kazuhiro Yoshida
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Akira Tsuburaya
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Junichi Sakamoto
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Satoshi Morita
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Hiromichi Maeda.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethics standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethics standards.

Conflict of interest

The authors declare that they have no conflict of interest.

Financial support

This study was supported by the Epidemiological and Clinical Research Information Network (ECRIN), a non-profit organization.

Additional information

Hiromichi Maeda and Maho Sato contributed equally to this work.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Maeda, H., Sato, M., Kobayashi, M. et al. Validity of the Japanese version of functional assessment of cancer therapy-gastric (FACT-Ga) and its sensitivity to ascites volume change: a retrospective analysis of Japanese clinical trial participants. Support Care Cancer 24, 4515–4521 (2016). https://doi.org/10.1007/s00520-016-3290-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00520-016-3290-3

Keywords

Search

Navigation