Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 16, 2020
Open Peer Review Period: Jan 16, 2020 - Feb 17, 2020
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Development of a short instrument for measuring health related quality of life in oncological patients for the use in clinical routine – observational study protocol
Cancer patients often suffer from the physical and psychological burden of their disease and its treatment which are frequently not sufficiently identified nor addressed in clinical routine. In the context of improving patient-centered care of oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO-measurements for cancer patients are unsuitable for routine procedures due to their length and complexity.
Therefore, it is the aim of this study to develop and psychometrically test a short questionnaire to measure HrQoL in cancer patients for use in routine care.
This observational study consists of two parts:  a qualitative study to develop a short questionnaire measuring HrQoL and  a quantitative study to psychometrically test this questionnaire at five oncological departments of a comprehensive cancer center. In study part 1, semi-structured interviews with 28 cancer patients as well as five focus groups with 22 clinicians and nurses will be conducted to identify clinically relevant dimensions of HrQoL. The identified dimensions will be complemented with related dimensions of empirical studies and discussed in an expert discussion. On this basis a short instrument will be developed. In study part 2, the developed questionnaire will be tested in cancer in- and out-patients of five participating oncological clinics using additional standardized questionnaires assessing HrQoL and further important PROs. The questionnaire will be presented to 770 patients twice during treatment.
With five to six dimensions of one item each, the developed questionnaire is short enough, to not disrupt routine procedures during treatment and is profound enough, to inform clinicians about the patient’s problems and course concerning HrQoL. Clinical Trial: This study was registered at Open Science Framework (https://osf.io/y7xce/).
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