nach oben

Erschienen in:

01.09.2015 | Original Article

Validation of the Japanese version of HFS-14, a disease-specific quality of life scale for patients suffering from hand-foot syndrome

verfasst von: Naoko Mikoshiba, Noriko Yamamoto-Mitani, Kazuki Sato, Yoshinari Asaoka, Takamasa Ohki, Misato Ohata, Mitsunori Miyashita

Erschienen in: Supportive Care in Cancer | Ausgabe 9/2015

Einloggen, um Zugang zu erhalten

Abstract

Purpose

The purpose of this study was to develop a Japanese version of hand-foot syndrome (HFS)-specific quality of life (QOL) questionnaire (HFS-14) to evaluate and monitor the QOL of patients with a possibility of HFS.

Methods

The original English version of HFS-14 was translated and slightly modified into Japanese, and the Japanese HFS-14 was administered to 187 patients receiving chemotherapy with high risk of developing HFS as outpatients in four institutions in Japan. Factor validity, internal consistency, correlation with the Skindex-16 and Dermatology Life Quality Index (DLQI) scores, known group validity, and test-retest reliability were analyzed for 105 patients who developed HFS. Next, we compared HFS-14 with DLQI and Skindex-16.

Results

Factor analysis confirmed the factor structure (one putative scale) of the Japanese HFS-14. Cronbach’s alpha was over 0.90. The Japanese HFS-14 score was correlated with the Skindex-16 and DLQI score. Intra-class correlation coefficients were over 0.80. Patients with severe HFS reported significantly poorer HFS-14 score than those with mild HFS. The Skindex-16 and DLQI scores were also significantly different in patients with different Common Terminology Criteria for Adverse Events (CTCAE) grades, but with smaller effect sizes than those for the HFS-14 score.

Conclusions

The Japanese HFS-14 provides a valid and reliable score for monitoring and evaluating HFS.

Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (2011) http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm). Accessed 11 Sep 2013

Fujisaka Y, Horiike A, Shimizu T, Yamamoto N, Yamada Y, Tamura T (2006) Phase 1 clinical study of pegylated liposomal doxorubicin (JNS002) in Japanese patients with solid tumors. Jpn J Clin Oncol 36:768–774PubMedCrossRef

Hyodo I, Shirao K, Doi T et al (2006) A phase II Study of the global dose and schedule of capecitabine in Japanese patients with metastatic colorectal cancer. Jpn J Clin Oncol 36:410–417PubMedCrossRef

Twelves C, Wong A, Nowacki MP et al (2005) Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 352:2696–2704PubMedCrossRef

Robert C, Mateus C, Spatz A, Wechsler J, Escudier B (2009) Dermatologic symptoms associated with the multikinase inhibitor sorafenib. J Am Acad Dermatol 60:299–305PubMedCrossRef

Tomita Y, Shinohara N, Yuasa T et al (2010) Overall survival and updated results from a phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma. Jpn J Clin Oncol 40:1166–1172PubMedCrossRef

Belum VR, Wu S, Lacouture ME (2013) Risk of hand-foot skin reaction with the novel multikinase inhibitor regorafenib: a meta-analysis. Invest New Drugs 31:1078–1086PubMedCrossRef

Nardone B, Hensley JR, Kulik L et al (2012) The effect of hand-foot skin reaction associated with the multikinase inhibitors sorafenib and sunitinib on health-related quality of life. J Drugs Dermatol 11:e61–e65PubMed

Rivera E, Valero V, Syrewicz L et al (2001) Phase I study of stealth liposomal doxorubicin in combination with gemcitabine in the treatment of patients with metastatic breast cancer. J Clin Oncol 19:1716–1722PubMed

10.

Shahrokni A, Rajebi MR, Saif MW (2009) Toxicity and efficacy of 5-fluorouracil and capecitabine in a patient with TYMS gene polymorphism: a challenge or a dilemma? Clin Colorectal Cancer 8:231–234PubMedCrossRef

11.

Park YH, Ryoo BY, Lee HJ, Kim SA, Chung JH (2003) High incidence of severe hand-foot syndrome during capecitabine-docetaxel combination chemotherapy. Ann Oncol 14:1691–1692PubMedCrossRef

12.

Gressett SM, Stanford BL, Hardwicke F (2006) Management of hand-foot syndrome induced by capecitabine. J Oncol Pharm Pract 12:131–141PubMedCrossRef

13.

Azuma Y, Hata K, Sai K et al (2012) Significant association between hand-foot syndrome and efficacy of capecitabine in patients with metastatic breast cancer. Biol Pharm Bull 35:717–724PubMedCrossRef

14.

von Gruenigen V, Frasure H, Fusco N et al (2010) A double-blind, randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin-related hand-foot syndrome in gynecologic oncology patients. Cancer 116:4735–4743CrossRef

15.

Sibaud V, Dalenc F, Chevreau C et al (2011) HFS-14, a specific quality of life scale developed for patients suffering from hand-foot syndrome. Oncologist 16:1469–1478PubMedCentralPubMedCrossRef

16.

Blanco-Aparicio M, Vazquez I, Pita-Fernandez S, Pertega-Diaz S, Verea-Hernando H (2013) Utility of brief questionnaires of health-related quality of life (Airways Questionnaire 20 and Clinical COPD Questionnaire) to predict exacerbations in patients with asthma and COPD. Health Qual Life Outcomes 11:85PubMedCentralPubMedCrossRef

17.

Delate T, Coons SJ (2001) The use of 2 health-related quality-of-life measures in a sample of persons infected with human immunodeficiency virus. Clin Infect Dis 32:E47–E52PubMedCrossRef

18.

Feyers D MD, ed. (2009) Quality of life: assessment, analysis and interpretation (second edition). John Wiley and sons, New York

19.

Higaki Y, Kawamoto K, Kamo T, Horikawa N, Kawashima M, Chren MM (2002) The Japanese version of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Dermatol 29:693–698PubMedCrossRef

20.

Takahashi N, Suzukamo Y, Nakamura M et al (2006) Japanese version of the Dermatology Life Quality Index: validity and reliability in patients with acne. Health Qual Life Outcomes 4:46PubMedCentralPubMedCrossRef

21.

Gerbrecht BM, Kangas T (2004) Implications of capecitabine (Xeloda) for cancer nursing practice. Eur J Oncol Nurs 8(Suppl 1):S63–S71PubMedCrossRef

22.

Cohen J (1992) A power primer. Psychol Bull 112:155–159PubMedCrossRef

Titel: Validation of the Japanese version of HFS-14, a disease-specific quality of life scale for patients suffering from hand-foot syndrome
verfasst von: Naoko Mikoshiba
Noriko Yamamoto-Mitani
Kazuki Sato
Yoshinari Asaoka
Takamasa Ohki
Misato Ohata
Mitsunori Miyashita
Publikationsdatum: 01.09.2015
Verlag: Springer Berlin Heidelberg
Erschienen in: Supportive Care in Cancer / Ausgabe 9/2015
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-015-2638-4

Springer Medizin

Validation of the Japanese version of HFS-14, a disease-specific quality of life scale for patients suffering from hand-foot syndrome