Development and validation of the system of quality of life instruments for cancer patients: Head and neck cancer (QLICP-HN)☆
Introduction
The head and neck cancer (HNC) is a life-threatening disease with high incidence in many countries including China.[1], [2] It is one of the sixth most prevalent worldwide neoplasm and accounts for 5% of all cancers in the Western world, with an estimated 900,000 new cases diagnosed annually. Independently of tumor site (oropharynx, oral cavity, sinus and nose, larynx), surviving patients experience a deterioration of their basic functions affecting such important functions as: breathing, mastication, salivating, swallowing, speaking, senses (hearing, taste, and smell).[3], [4] Both HNC and its treatment have significant and often devastating effects on the function, appearance, psychological status, socialization and consequently QOL of patients. Furthermore, due to the disabling effects of both the cancer and its treatment, patients with HNC have specific needs beyond those of most people diagnosed with other cancers.5
There is general recognition of the need to assess the impact of cancer and its treatment on patient’s health-related quality of life (HRQOL),[6], [7] while traditionally cancer outcomes (overall survival, disease free survival, time to disease progression, and other disease variables) remain essential. Consequently, several specific instruments for patients with head and neck cancer have been developed and are widely used in cancer clinical researches, including EORTC (European Organization for Research and Treatment of Cancer) QLQ-C30[8], [9] and QLQ-H&N35,[10], [11], [12] FACT-H&N (Functional Assessment of Cancer Therapy – Head and Neck).[13], [14]
However, very few Chinese QOL instruments are available even more and more clinicians and researchers are concerned with the QOL of patients with head and neck cancer in China, which impedes research and applications of QOL in this field greatly. Although the Chinese versions of QLQ-H&N35 and FACT-H&N can be used for Chinese patients,[15], [16], [17] they are lacking Chinese cultural backgrounds to some extent considering their original use in English-spoken patients. It is well known that QOL is highly culture dependent.[18], [19], [20], [21] The World Health Organization Quality of Life Assessment (WHOQOL) group proposed that perceptions and interpretations are rooted in that person’s culture and that has directly and formally incorporated cultural components as integral to its definition rather than acknowledging cultural influence as an extraneous variable. And thus the WHOQOL group defines QOL as an individual’s perceptions of their position in life, in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.22 This theoretical orientation towards culture as a focal part of QOL has explicitly directed the cross-cultural validations of QOL instruments or the developments of new instruments in largely different cultures.[18], [19], [20], [21], [22] Moreover, it is highly recognized that there are big differences between the Western culture and the Eastern culture with the Chinese being the representative.[20], [23], [24], [25] For example, in Chinese culture, the family relationship and kinship play very important roles in daily life. Personal achievement sometimes gives way to the well-being of the (extended) family. Taoism and traditional medicine focus on good temper and high spirit. Good appetite, sleep, and energy are highly regarded in daily life with food culture being very important in China. This kind of culture dependence does not reflect in most QOL instruments in other languages. Therefore, it is necessary to develop Chinese specific QOL instruments and a lot of Chinese QOL experts have been appealing to develop Chinese own instruments as Xiang et al. saying “the inclusion of QOL measures in routine clinical practice and research in Chinese societies should be encouraged and culture-sensitive QOL measures should be developed”.20 In response to this need, the Chinese QOL instruments system called QLICP (Quality of Life Instruments for Cancer Patients) was developed by module approach.[26], [27] This system includes a general module (QLICP-GM) which can be used with all types of cancer, and specific modules for different cancer with each module being used for only the relevant disease.[23], [24], [25] As an example, the head and neck cancer instrument of this system, QLICP-HN (Quality of Life Instruments for Cancer Patients-Head and Neck Cancer), was formed by combining the general module (QLICP-GM) and the specific module of the head and neck cancer. At present, the QLICP-GM and 14 specific modules have been developed or are developing, and thus, 14 cancer-specific QOL instruments were formed, namely, head and neck cancer (QLICP-HN), lung cancer (QLICP-LU), breast cancer (QLICP-BR), colorectal cancer (QLICP-CR), liver cancer (QLICP-LI), esophageal cancer (QLICP-ES), stomach cancer (QLICP-ST), bladder cancer (QLICP-BL), prostate cancer (QLICP-PR), cervical cancer (QLICP-CE), ovarian cancer (QLICP-OV), brain cancer (QLICP-BN), leukemia (QLICP-LE), and lymphoma (QLICP-LY). This paper is aimed to report the developmental process and validation of the QLICP-HN.
Section snippets
Establishment of the general module (QLICP-GM)
Two working groups, the nominal group of 16 persons and the focus group of 10 persons, were organized. The focus group was composed of two physicians for patients with cancer and eight researchers (three in QOL/medical statistics, one in epidemiology, two in sociology, two in psychology), while the nominal group contained six physicians, two nurses, two medical educator/managers for cancer, and six researchers (two in QOL/medical statistics and epidemiologist, two sociologists, and two
Socio-demographic and clinical characteristics
The total sample included 133 patients with head and neck cancer varied in age from 11 to 87 with a median age of 54.0 and mean age 52.0 ± 15.4. The majority were married (123 cases, 92.5%), male (98 cases, 73.7%), while 10 (7.5%) were single, 35 patients (26.3%) female. 30 (22.5%) patients finished primary school, while 82 (61.7%) completed high school and professional secondary school, and 21 (15.8%) had a college degree; ethnics of Han is 103 cases (77.5%) while others is 30 (22.5%);
Discussions
This paper focused on the main steps of developments and validation of the QLICP-HN. Considering same-class diseases such as cancer often share many things in common, a popular approach in recent years has been to develop a general module for a class of diseases and then additional modules to capture individual differences in different diseases, with the QLQs from EORTC (European Organization for Research and Treatment of Cancer) and the FACTs from CORE (Center on Outcomes, Research and
Conflict of interest statement
None declared.
Acknowledgments
In carrying out this research project, we have received substantial assistance from David Cella, Sonya Eremenco, Benjamin J. Arnold and Hiramatsu Toshiko at CORE, Evanston- Northwestern Healthcare, and also from Xueliang Tang, Yubo Lu at the Yunnan Tumor Hospital. We sincerely appreciate their kind help.
References (35)
Widening perspectives: quality of life as a measure of outcome in the treatment of patients with cancers of the head and neck
Oral Oncol
(1994)- et al.
Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of in patients with cancer
Ann Oncol
(2008) - et al.
A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients
Eur J Cancer
(2000) - et al.
Health-related quality of life and culture
Semin Oncol Nurs
(2010 Feb) - et al.
Development and validation of the system of quality of life instruments for cancer patients: lung cancer (QLICP-LU)
Lung Cancer
(2008) - et al.
Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system
Arch Phys Med Rehabil
(2002) - et al.
Methods for assessing responsiveness: a critical review and recommendations
J Clin Epidemiol
(2000) Head and neck cancer and the quality of life
Otolaryngol Head Neck Surg
(1993)- et al.
Quality of life in patients of nasopharyngeal carcinoma: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and the EORTC QLQH&N35
Qual Life Res
(2003) - et al.
Geriatric oncology: comparing health related quality of life in head and neck cancer patients
Head Neck Oncol
(2011)
A UK multicentre pilot study of speech and swallowing outcomes following head and neck cancer
Clin Otolaryngol
The quality of life committee of the clinical trials group of the National Cancer Institute of Canada: organization and functions
Qual Life Res
Quality of life and psychosocial oncology research in Europe: state of the art
J Psychosoc Oncol
The European organization for research and treatment of cancer QLQ-C30: a quality of life instrument for use in international clinical trials in oncology
J Natl Cancer Inst
Quality of life in head and neck cancer patient: validation of the European organization for research and treatment of cancer QLQ-C30 and European organization for research and treatment of cancer QLQ-H&N35 in Indian patients
Indian J Cancer
Assessing quality of life in patients with head and neck cancer, cross-validation of European organization for research and treatment of cancer (EORTC) quality of life head and neck module (QLQ-H&N35)
Arch Otolaryngol Head Neck Surg
Interpreting differences in quality of life: the FACT-H&N in laryngeal cancer patients
Qual Life Res
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Supported by: The Natural Sciences Funds of Yunnan Province (2008CD055) and Research Fund of University Top Talent Project of Guangdong Province (GK1003).
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Zheng Yang and Jiahong Luo are as the first co-authors with the same contributions.
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