An international field study of the EORTC QLQ-PR25: A questionnaire for assessing the health-related quality of life of patients with prostate cancer
Introduction
Worldwide, after lung cancer, prostate cancer is the most commonly diagnosed malignant tumour in men, with an estimated 40 million affected individuals in North America, Europe and Japan.1, 2 Patients with localised prostate cancer without distant metastasis (T1–2, N0, M0) can be treated with curative intent with either surgery or radiotherapy, with or without hormonal therapy. To date, there is no convincing evidence demonstrating survival superiority of any one of these approaches to curative treatment.3, 4, 5 Alternative disease management strategies include active surveillance and watchful waiting.6
Patients with locally advanced prostate cancer, with lymph node metastases or with distant (bone) metastases, cannot be cured. The first-line palliative treatment is hormonal. Patients with locally advanced prostate cancer typically receive external radiation combined with hormonal treatment.4, 7
In choosing amongst the various treatment options, not only are the issues of disease-free and overall survival important, but also the effect of the disease and its treatment on patients’ health-related quality of life (HRQOL). Due to the range of treatment options available, and the differential effects of various treatments on patients’ symptoms and functional health, HRQOL considerations may play an even greater role in treatment decision-making than is the case for some other types of cancer.
The EORTC employs a modular approach to assessing cancer patients’ HRQOL, including a core questionnaire, the QLQ-C30, intended for use across a wide spectrum of patient populations, and supplemental questionnaire modules, designed to assess HRQOL issues most relevant to a specific patient population.8 The EORTC has established standardised procedures for the development of condition-specific HRQOL questionnaire modules.9 Although other questionnaires are available for the assessment of prostate cancer patients’ HRQOL, including the Functional Assessment of Cancer Therapy – Prostate (FACT-P),10 the University of California, Los Angeles – Prostate Cancer Index (PCI)11 and the Expanded Prostate Cancer Index Composite (EPIC),12 it was considered desirable and appropriate to generate a questionnaire that is compatible and consistent with the measurement strategy employed within the EORTC. This paper reports the results of the international psychometric field testing of the prostate cancer-specific HRQOL questionnaire module, the QLQ-PR25.
Section snippets
Patients
Patients were recruited from March 2002 to December 2004, with follow-up data collected through 2005. The study was coordinated at the Quality of Life Department of the EORTC Headquarters in Brussels, Belgium (EORTC Protocol 15011-30011). Patients were prospectively registered before treatment, and were eligible to participate if they had a histologically confirmed diagnosis of prostate cancer, had no previous treatment for their prostate cancer and did not have cerebral metastases or
Patient characteristics
Between March 2002 and December 2004, 642 patients from 34 institutions in 13 countries were entered into the study. Of these, 53 patients were determined not to have met the eligibility criteria. The primary reasons for ineligibility included the presence of concurrent malignancies, prior hormonal treatment and prior non-hormonal treatment within 2 years of study entry. Of the remaining 589 patients, 80 could not be included in the final analysis due to missing treatment forms, use of the
Discussion
The results of this international field study of the QLQ-PR25 generally support its psychometric robustness. The questionnaire was well accepted by patients, yielded high compliance rates and proved to be acceptable to the large majority of patients. As expected items assessing sexual functioning were experienced as problematic by some elderly patients.
The results confirmed the hypothesised scale structure and reliability of 3 of the multi-item scales – urinary symptoms, sexual activity and
Conflict of interest statement
None declared.
Acknowledgements
This work was funded by the EORTC Quality of Life Group and, in part, by Grants 2U10 CA11488-36 through 5U10 CA011488-38 from the National Cancer Institute (Bethesda, MA, USA). Its contents are solely the responsibility of the authors, and do not necessarily represent the official views of the National Cancer Institute. This work was also supported, in part, by the EORTC Charitable Trust and FOCA. Fabio Efficace and Sven D’Haese undertook this work whilst employed at the EORTC Headquarters,
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